10 Most Innovative CROs To Watch In 2023.pdf

Industry
Sagacity
The Impact of
Emerging Technologies
on The Pre-Clinical
CRO Market
Most
Dr Ibrahim Farr
Chairman and CEO
Pivotal
Redeﬁning
Advancements
Role of CROs in
Shaping the Future
of Clinical Research
A Name Synonymous to Innova ons

RESEARCHING
and Educating
to SAVE lives.

Editor’s
Note
uring the COVID-19 pandemic, if clinicians,
Dhealthcare service-providing staff, nurses, and
doctors were battling at the forefront, then the
Clinical Research Organizations (CROs) have been
working hard in the background to develop effective
vaccines to fight this novel coronavirus.
With millions of cases emerging every day globally, the
demand for quick vaccination raised the expectations from
the CROs to rise to the occasion and intensify their vaccine
research, clinical trials, testing and developmental efforts,
which they did in a record time.
Because of their tremendous efforts, we as a global unit
came up with nearly a dozen vaccines already being
deployed worldwide, with over sixty-eight per cent global
population vaccinated at least once.
These are tremendous achievements while these CROs are
further advancing their forces to find more possible ways
through novel technologies to mitigate the virus spreading
and boost the global population’s immunity further.
The Augmenta ons
for Perpetual
Be erments

The momentum will be carried forward as predicted by the
Reportlinker’s report. According to the report, the global
CRO market is projected to grow at a CAGR of 10.06%
during 2022-26 and reach $40 billion by the end of 2026.
The report further states that the market will be further
driven by the growing biopharmaceutical industry,
increased global R&D expenditure and investment,
regulations of clinical trials, and technological innovations
in the healthcare industry, particularly in the CRO end-user
market segment and geographical landscape.
To grasp these very positive scenarios for the present and
future of the CRO industry, Insights Care’s team unveiled
this exclusive edition of the ‘10 Most Innovative CROs To
Watch In 2023.’ These ten CROs are among the disruptive
innovators when it comes to clinical trials, R&D, and
assisting the vaccine development drive. Also included in
this edition are two trendy articles our in-house editorial
team curated to give you a holistic view of the entire
scenario.
Flip through the following pages and witness CROs’
futuristic leap into a healthier tomorrow; enjoy!
-Anish Miller

Cover
Sto A Name Synonymous to Innovations
08
PIVOTAL
C O

Articles
e Impact of Emerging Technologies
on e Pre-Clinical CRO Market
Industry Sagacity
16
Role of CROs in Shaping the Future
of Clinical Research
Redeﬁning Advancements
28
20
24
32
Providing Synergic Solutions
for win-win Outcomes
CLINERGY HEALTH
RESEARCH
Blend of Innovations
Assuring Adaptability
OnQ Research
GENE THERAPY AND
CANCER TREATMENT
CXO
N T E N T S

Co-designer Paul Belin
Art & Picture Editor
Mrunalinee Deshmukh
Art & Design Head
Editor-in-Chief Pooja Bansal
Managing Editor Abhishek Joshi
Senior Editor Anish Miller
Visualiser David King
Research Analyst Eric Smith
Sarah Wilson, John Smith, Alex Vincent
Business Development Executives
Amy Jones
Business Development Manager
Sales Executives Kelli, Bill, Anna
SME-SMO Executives Gemson
Digital Marketing Manager Alina Sege
Technical Consultants David, Robert
Technical Head Jacob Smile
Marketing Manager John Smith
Assistant Technical Head Amar Sawant
Assistant Digital Marketing Manager Renuka Kulkarni
Assisting Editors Saloni, Drishti
Sonia Raizada
Circulation Manager Tanaji Fartade
Copyright © 2023 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or
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January, 2023
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BRIEF
FEATURING
COMPANY
1MED SA
1med.ch
Enrico Perfler
CEO
1MED is a Swiss-based regulatory and quality consultancy
company and full service CRO.
Biomapas
biomapas.com
Audrius Sveikata
CEO
Biomapas is a func onal and full outsourcing solu on
provider to the global life science industry.
Tiago M D da Silva
Managing Director
CLINERGY Health Research
clinergyhealth.com
CLINERGY was created to fill gaps le by the tradi onal
outsourcing model and to leverage opportuni es for the
healthcare industry and clinical sites on a cost-effec ve
way, so that health innova on reaches pa ents faster.
Ino v
ino vco.com
Bob Leasure
CEO
Through scien fic leadership and ongoing investments,
Ino v delivers a comprehensive range of nonclinical and
analy cal services that will exceed your expecta ons.
Link Medical Research
linkmedical.eu
Ola Gudmundsen
CEO
LINK Medical is a full-service Nordic CRO providing
product development services for the pharmaceu cal
and medical device industries across Northern Europe.
NDA Regulatory
Science (NDA Group)
ndareg.com
Chris ne Lind
Vice President
Commercial
NDA is a leading regulatory drug & device development
consultancy, suppor ng companies with their regulatory,
pharmacovigilance, quality and strategic planning.
OnQ Research
onqsa.co.za
Catherine Lund
Founder and
Managing Director
OnQ Research is a South African contract research
organisa on that offers services to assist with the en re
con nuum of clinical research.
Orphan Reach
orphan-reach.com
P.R.I.S.M.A.- CRO GmbH
prisma-cro.com
Thomas Ogorka
CEO
Orphan Reach is a full-service CRO with clinical
opera ons in place since 2002.
PIVOTAL
pivotalcr.com
Gernot Cremer
MD
P.R.I.S.M.A. is a German Clinical Research Organiza on
(CRO) and dedicated to support the European por on of
the pharmaceu cal and biotech industries’ clinical
development programs.
Dr Ibrahim Farr
Chairman and CEO
Pivotal is a Contract Research Organiza on that weaves
together the scien fic insight, the technology and the
resources to help customers address both current and
future needs.
10 MOST INNOVATIVE CROs TO WATCH IN 2023

A Name Synonymous to Innova ons
,Pivotal’s team is
proud of being involved in the
ac va on, conduc on and the
execu on of discrete full
ac vi es of nearly 500 diﬀerent
clinical research projects in
quite dis nct therapeu c areas
and phases and with many
diverse inves ga onal
compounds, devices and
products.
10 Most Innova ve CROs To Watch In 2023

Dr Ibrahim Farr
Chairman and CEO
Pivotal

harmaceutical companies have been increasingly
Pusing outsourcing to be more efficient and effective
in drug development, help reduce time-to-market
and boost the ongoing commercial success of their
products. This shift is accelerating M&A across many
segments of outsourced pharmaceutical services. Across the
pharmaceutical value chain, outsourced services are gaining
traction, from drug discovery, contract research and contract
manufacturing to commercialization services, safety and
risk management and pharmaceutical IT.
CROs generally employ an expertise-driven, project-based
consulting model that requires strategy and capability
around managing complex trials. Most importantly, while
some large service providers exist in this segment,
significant consolidation opportunities exist. In comparison,
the preclinical CRO market is more mature and
consolidated. Over the years, many large pharmaceutical
manufacturers have moved from working with a set of
preferred providers to forming strategic partnerships with
only one or two large CROs.
Nevertheless, other pharma and, preferably
biotechnological, companies do still prefer to work with a
set of qualified mid-size CROs in order to provide them
with more personalized focused specialized services.
With the objective of becoming a reliable full-service CRO,
Pivotal was born back in 2001 on the principle that
strategic scientific and medical advice and support should
be the backbone of all clinical trials with proper and
sufficient resources to cover not only the execution of all
essential aspects and stages of clinical trials from setup to
execution to termination, including clinical monitoring and
project management.
Under the leadership of Dr Ibrahim Farr, Chairman and
CEO, Pivotal also oversees other complementary activities
such as medical monitoring and writing support, or
pharmacovigilance and data-management and biostatistical
services, i.e., almost all that it takes to complete a clinical
trial, while just leaving some very specialized tasks (e.g.,
drug depot services or lab. analytics) in the hands of very
specialized vendors independent from the company.
The Profound Legacy
Now, almost 21 years from its foundation, Pivotal’s team is
proud of being involved in the activation, conduction, and
the execution of discrete full activities of nearly 500
different clinical research projects in quite distinct
therapeutic areas and phases and with many diverse
investigational compounds, devices and products.
With some more detail, Pivotal has been engaged, up to
date, in a total of 361 clinical trials – from phase 1 to phase
4- that involved the management of almost 6,000
investigational sites and >40,000 patients and in close to
115 non-interventional studies (NIS) which involved, in
turn, the handling of >9,000 sites and >62,000 patients. Or
in “big numbers”: an accumulated experience resulting
from working with >15,000 sites and >100,000 patients–a
heavy backpack to support its expertise and knowledge.
Pivotal’s team genuinely believe this all has only been
possible because of their proven experience in and deep
knowledge of the clinical research landscape and because of
the high quality with which Pivotal´s associates face and
manage all clinical projects that have been entrusted with –
all of these aspects a trademark of Pivotal and which have
warranted an essential number of clients repeating business
with us (almost 75% of repeat business), and others turning
to Pivotal to assume the rescue of their on-going trials when
“not flowing” as planned (some 32 clinical trials to date).
Yet, and aside from all those more general and technical
features defining Pivotal, the team believes that its most
essential strengths come not only from themselves but also
,Pivotal’s team
genuinely believe this
all has only been possible
because of their proven
experience in and deep
knowledge of the clinical
research landscape.

from its internal culture and a unique way of approaching
their clients and their concerns, always from a personal
perspective and commitment to deliver high-quality results.
The Continuum of Success
Over the years, Pivotal has succeeded in attracting–and
retaining- exceptional associates, all committed to and
passionate about clinical research and delivering medical
solutions much closer to patients. Such “exceptionality” can
be found at all operational levels, and its staﬀ–particularly
its senior management teams- is absolutely approachable
and directly–and personally-involved in all projects that the
company collaborates with.
Pivotal and its associates are pretty aware of how costly and
crucial every single project might be for the clients. They
feel unable to get into any clinical study–ample or
“tiny”- without putting the company’s experience and
knowledge into them.
When working with Pivotal, clients do not simply work
with “individuals” but with a robust team driven by a “one-
team” attitude, commitment, and integrity. Pivotal tries to
keep its customers in the center of its work, listen to their
inputs, and put itself in their shoes to better comprehend
their needs to become an extension of their teams.
Last, it is important to mention that apart with its clients,
Pivotal aims to stay connected with the “ecosystem” –
namely, the whole clinical and innovation communities- to
warrant in-time access to breakthrough science, best sites,
talent, and technology—delivering daily to its clients, and
making sure every deliverable, document, slide, or message
is clear, adds value and, eventually, reduces time to market.
This all is what, the team believes, has made Pivotal a
favorite partner for a high number of Biotech and Pharma
companies.
Adapting to the post-COVID-19 Clinical Trials Scenario
It was undoubtedly unthinkable back in 2019 that a
“catastrophe” like what the COVID-19 pandemic has
represented could simply happen and, much less predict all
the eﬀects it brought alongside–at a global level and,
obviously, at any smaller single compartment of human
lives, including the clinical research ecosystem.
Analyzing how the COVID-19 has impacted the clinical
trials–and may impact in the future- is not a

straightforward question but rather a polyhedric complex
problem requiring simultaneous looks from quite different
but complementary angles.
Firstly, it has affected all companies developing new
medical solutions for patients, including Biotech and
Pharma and other supporting-services companies like
clinical CROs. Then, undoubtedly, it has impacted the
organization of investigators at investigational sites who
had had to adapt, from one day to the next one, to a
different way to handle and manage their clinical research
activities and their patients–with patients not able to attend
their visits at the sites.
And last, likely the most critical link of the chain, it has had
an impact on thousands of patients being treated in the
context of clinical trials, frightened that the hopes they put
in every new treatment they were helping to develop for
themselves and for others may simply fly away. However,
despite the potentially terrible scenario that COVID-19 may
have resulted in, all actors involved in clinical research
have found a way to move forward and overcome all
hurdles encountered.
Indeed, the COVID-19 pandemic and all lessons learned
will condition the clinical trials arena in the future and how
all actors involved play their respective roles. And potential
new clinical research scenarios and rules will need to be
considered, yet still maintaining patients at the very core,
warranting their rights, hopes and illusions and having them
reassured at every moment–may other pandemic burst out
(or any other similar event) that they, patients, will be
treated as needed and deserved.
Among the lessons taken from the “COVID-19 experience,
Pivotal has learned that there are alternatives to the classical
face-to-face visits to sites and that data can still be collected
and verified remotely as much as possible. But also, others
by simply using online technologies that allow patients to
transmit outcomes, as per the corresponding protocol. Or in
other words, the COVID-19 pandemic has probably opened
up the door to that new type of decentralized clinical trials
(DCTs). Advantages, disadvantages and challenges of DCTs
vs. centralized trials will require, on the other hand, deep
discussion in another article and this is beyond the topics
that pretend to be now covered.
Pivotal also experienced that during this COVID-19 period,
the study treatment–commonly administered at each
investigational site- can be efficiently delivered to patients
by post or courier to the safety of their homes for self-
administration. And that even for more complex
administration routes requiring, for instance, injections,
specialized staff may visit patients at their places for dosing
–and, why not, to collect samples as needed.
Nevertheless, and despite the alternatives just pointed out
and applied by Pivotal, there will surely be many
procedures, trial activities and measures or trial compounds
– e.g., particularly unstable- that will not allow an easy shift
to this potential new model of making clinical research
home-friendly.
Be as it may, the “take-home” message from the COVID-19
outbreak is that alternative ways of doing clinical research
are possible and that “rethinking” clinical trial designs and
operational approaches are much more than recommended.
All parties–from sponsors to investigators and sites to
patients and regulators- must change their mindsets and
look at these alternatives with interest since they may also
help to reduce the overall costs of clinical investigations.
And Pivotal and other clinical CROs, on their side, will
have to adapt their operational procedures to this new
clinical research (remote) environment–surely, a long way
to go ahead, but much motivating.
,Pivotal definitely wants to
play the new game of DCTs but
always remains true to its client-
oriented and pa ent-centric
a tude, its commitment, and
strong belief in science and
quality as the basis to build on
medical discoveries and
advances.

Innovation and new technologies will be the basis of this
potential transformation, which is already in Pivotal’s
DNA. Thus, the company meets the first “inclusion
criterion” for this new environment and paradigm shift.
And for the future, the company considers, if not entirely
shifting to DCT-like approaches, at least to start walking
that new pathway parallel to the classical one. Pivotal
definitely wants to play the new game but always remains
true to its client-oriented and patient-centric attitude, its
commitment, and strong belief in science and quality as the
basis to build on medical discoveries and advances.
Embracing the Future Roadmap
The CRO market is constantly moving, and on the basis
thereof, “M&A” processes rely on. And as a consequence
of this, new giant actors emerge every year while smaller
CROs suffer, if not literally close the business. Niche
specialization or shifting to new target sponsors – e.g.,
biotech- may help them to survive and thrive, though.
These are certainly the market rules but are a trend that may
deprive the smaller innovators Biotech of partnering with
the right-size yet experienced CROs if no other actors can
be found out there. Not much to do to stop the market’s
hunger, but just sending a message to smaller innovators
and sharing the thought that rightsizing is still a valid
principle for sponsors to consider when selecting their
partner CRO–hence, mid-size CROs such as Pivotal will
surely be much more agile and will put their clients´
projects among those much more important for the client.
Mid-size and smaller focused CROs are likely different
from merged giants in that they may be just one more team
member of their clients and work incredibly close to the
proper clients´ internal teams. And at least, this is what the
company has been doing and pretending at Pivotal and what
has been the basis for its success story to date.
The future starts today, actually, and for 2023 Pivotal
intends to keep growing while remaining faithful to the
“organic growth” policy it has been following since
inception – rather than basing its expansion solely on
“M&A” operations-. Therefore, the company plans to offer
something else to entice old and new clients. COVID-19
outbreak has pointed out the new pathway to follow-DCTs,
digitalization, technology- and, as already mentioned, this is
a maneuver in which the company has already been
investing to get there. But in the short term, Pivotal plans to
work towards giving an impulse to the science behind
clinical research.
With this objective in mind, the company has onboarded
new talent forged in a research-making environment with a
proven capacity for planning and conducting experiments
and, importantly, for analyzing, interpreting, and publishing
results.
Pivotal’s ultimate idea is to provide such strategic scientific
analysis and advice to its clients in every new project it is
awarded, in real-time, so that rapid but robust decisions on
how to progress forward can be made, avoiding the
compromising of a total budget in a project that may have
lost sense or which may benefit from re-focusing.
An independent Look at Pivotal
Pivotal is proud of being the foundation it is today, and its
team believes in “we-are-Pivotal;” hence it runs the risk of
acting subjectively when giving marks to the company.
External independent opinions may help, though. These
words of wisdom showcase the status quo of
Pivotal—being one of the innovative CROs in the
healthcare industry. Detailed quotes are depicted in our
website at www.pivotalcr.comand at our patient journey
arm division at www.pivotalpatientjourney.com and below
is an example of these quotes:
“Pivotal continues to be my CRO of choice. They
complement our existing team by providing functional area
expertise that we do not currently possess. Their personnel
are highly engaged, experienced, and proficient in what
they do. Pivotal’ s leadership team is experienced and more
importantly, incredibly engaged throughout the entire study.
These are some of the reasons Pivotal continues to be a
trusted partner for us.” -Chief Operating Officer, at a US-
based Medical Device Co
“I have worked with Pivotal on two studies and have been
particularly impressed with the care they give studies, their
personal attention to the needs of sponsors, and their
dedication to getting things right. Pivotal is a closely-knit
group. There is no bureaucracy, simply the dedication to
serving the needs of their biotech clients. They are the
closest thing I can find to having my company personnel on
the ground in Spain and Europe.” -Chief Medical Officer, at
a US-based Biotech Co

“The team at Pivotal operates as a seamless extension of
our internal team, building trust with our European clinical
trial sites and our confidence in our ability to execute high-
quality clinical trials. The Pivotal management team acts as
a true partner, equally focused on our objectives to develop
innovative therapeutic treatments for patients with serious
unmet medical needs.” -Group Vice President, Development
Sciences Operations at a Mid-Size US Pharma Co
“As an independent investigator and head of a Cooperative
Group, I have been working with Pivotal since 2014 on six
projects in GU tumors and what I have encountered is a
dedicated team to clinical research, very much attentive to
the complex needs of independent investigators,
responsiveness and quality-minded throughout.
The team gets it right the first time in all the services,
including regulatory and clinical operations, medical and
safety monitoring, data management, and biostats. Pivotal is
my favorite CROs to work with, and I have no hesitation in
recommending it for any new trials in Oncology and
beyond in Europe.”-Senior Researcher PSMAR/IMIM
Hospital del Mar, Barcelona, Spain, and Associate
Professor of Medicine Harvard Medical School
“I have worked with Pivotal on international clinical trials
both of an ICU therapeutic and a cancer screening
device/diagnostic. I cannot think of a better partner. A cost-
effective collaborator with deep functional expertise,
particularly in data management, biostatistics, medical
monitoring, pharmacovigilance, and project management,
but even more importantly, a company with a culture of
problem-solving and shared responsibility.
Working with Pivotal is never “us” and “them”; it is one
shared mission with a group of professionals who simply do
whatever it takes to accomplish the goal. This starts at the
top, with the credible, expert, and ever-present leadership of
the CEO, himself a former senior Pharma drug developer,
and filters through every layer of the organization.”
-CEO, at a US-based Biotech Co.
“The patient recruitment process has been awe-inspiring,
and I have learned a lot through your company and your C-
Lys patient platform. You are making the world of research
a better place with your company and your ways.”
-Ophthalmologist and PI and Med. Monitor lead in FDA-
monitored clinical trials.
“And all of the above seems to be supported by the fact that
Pivotal was selected as one of the few firms that attracted
recognition from the Pharma IQ network as a RISING
STAR.”
The research base comprised international participants from
mainly big Pharma or Biotechs, SMEs pharma and
consultants, government bodies, medical device
manufacturers and public hospitals. We have kept doing as
good as then, so we are confident we will surely be
perceived now as we then were. Clients have the last word,
but business coming in aligns with this feeling.
,Pivotal has succeeded
in a rac ng – and
retaining- excep onal
associates, all commi ed
to and passionate about
clinical research and
delivering medical
solu ons much closer to
pa ents.

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Industry Sagacity
JANUARY | 2023 16

Technology is changing the health world’s future,
while future technology is reshaping the present
world of health. Already emerging from the
turbulent oceans of changing times are novel ways of
carrying out or performing preclinical research and
conducting trials.
Many giant Clinical or Contract Research Organizations
(CROs) have already started integrating their preclinical
research, testing, and trials with not only digital, virtual,
and remote technologies but are also implementing
Artificial Intelligence (AI), Cloud Computing, and
Machine Learning (ML) technologies to efficiently
conduct, perform, or carry out such experiments in
increasingly enhanced environments.
The process of developing a medicinal product is a long
one, where there are many subprocesses like idea or
concept generation, framing, discovering and developing
that idea further, then the pre-clinical research stage then
comes to the clinical trial stage, and finally, the FDA
assessment and review stage which approves or
disapproves the product based on its criteria.
The Power of Modern Tech
Although all these subprocesses are equally important, the
stage where pre-clinical research is conducted is the most
crucial one as the prospective product ideas or concepts
The Impact of
Emerging
Technologies on
the Pre-Clinical
CRO Market
JANUARY | 2023 17

have a strong chance of failing. This is where preclinical
CROs play a very major role in opting for advanced
technologies so they could research till the last element of
each idea and concept from every possible angle, and find
out the possibilities, and probabilities of the success and the
failure of the drug or medicine in development.
Modern technologies are not only giving more power to the
preclinical CROs to look at the preclinical trial process with
a holistic view increasing the probability of the drug or
medicine moving to the further stage but are also helping
them in saving huge costs.
Let us look in detail at these reasons and dig ourselves
deeper to gain a broader perspective.
A Holistic Tech Perspective:
Advance Technological Implementation lowers the
Uncertainty of the preclinical experiments by streamlining
and optimizing detailed data collection, easing down the
pre-clinical trials’ subject selection, decreasing the time
duration of research, and reducing financial costs. Research,
data collection, test subject selection and continuous
analysis are an integral part of drug research and medicine
development. However, with increasing intricacy in the
entire process, navigating through the continuous stream of
incoming data gets impossible for the human researcher.
This is where advanced technologies like automation, AI,
cloud computing, Big Data Analysis, ML, etc. provide not
only monitoring, tracing, tracking, and collecting data but
also deep and machine learning of the recorded data to offer
precise analysis, interpretation, flow, pattern while
matching the samples with earlier available ones.
Live COVID-19 Example:
It is because of using such novel technologies that in just a
year and a half, CROs across the world could come up with
more than a dozen coronavirus vaccines including Serum
Institute of India’s COVOVAX which has been developed
through three trials in one country and approved in five
countries, COVISHIELD (Oxford AstraZeneca
Formulation) developed through four trials in one country
and approved in 49 countries; Novavax’s NUVAXOVID
which has been developed through 17 trials in 13 countries
and approved in 38 countries; Oxford/AstraZeneca’s
VAXZEVRIA developed through 66 clinical trials in 31
countries and approved in 140 countries; and so on and so
forth.
Due to this rapid vaccine development, according to The
New York Times’ COVID vaccine tracker, as of July 2022
over 5.23 billion people or 68.2% of the world population
have received a dose of a COVID-19 vaccine.
Futuristic Technologies is the Future
Clinical trial researchers also get benefitted by gaining
actionable insights into the detailed reports created by using
digital technologies. For example, AI and ML are now
widely used in the most appropriate sample group selection
that responds more to the pre-clinical tests and trials.
The first major advantage of using these techs is the
automated cellular level selection, data generation and
analysis. These futuristic technologies modern cell-based
selection offers an early-stage issue identification and
problem detection with potential drug developments and
testing. It aids in reducing sample wastage, time, and effort,
and streamlines the entire process of research and
development. For example, data samples collected during
the research using AI can also be utilized for the most
suitable patient matching during the clinical trials testing
process.
Preclinical image, graphics, and sample matching and
analysis process automation are also feasible using techs
such as AI and ML. CROs are now increasingly using these
technologies for automated testing sample analysis,
identification of molecular compounds, and analyse patterns
for drug discovery.
For Example, AI is now being used by the Institute of
Cancer Research for making predictions regarding cancer
drugs’ novel prospects and performing repetitive tasks like
research record up-gradation and data extraction. Likewise,
scientists have successfully developed Eve, an AI Robot to
help researchers in speeding up the drug discovery process.
-Anish Miller
JANUARY | 2023 18

he Healthcare industry usually faces problems to
Tbridge the gap to solve the problems promptly, and
isn't it something that should be taken care of?
Acknowledging these concerns of filling up the operational
gaps and solving the problems in a timely manner,
Clinergy Health Research has solutions to a variety of
managerial issues while also providing a full revamp of all
the health care processes.
Having this problem-solving approach and abundant
experience, Tiago M D da Silva, Managing Director, has
scientific and management knowledge to enhance the
operational experience and deliver superior results.
In an interview with Insights Care, Mr. da Silva talks about
Clinergy roles and how it is making a significant difference
through its solutions into the healthcare niche.
Please brief our audience about Clinergy Health
Research, its USPs, and how it is positioned as a reliable
name in the CRO sector?
Clinergy is a CRO, but we always like to highlight that our
"C" stands for "Collaborative" rather than "Contract," and,
while for some people, that might look like a small detail, it
makes all the difference.
Being a Collaborative Research Organization means that
our structure, processes, values, and people are fully
focused on long-term value-adding partnerships rather than
on short-term transactional relationships with clients.
Such a mindset allows us to truly embrace our clients´
vision and ways of working. We act as an extension of their
team, focusing on what matters to them while feeling
empowered to "run the extra mile" to deliver operational
excellence.
This is now more important than ever as we see what has
been happing to the CRO environment over the past two
decades, with so many mergers and acquisitions resulting in
huge CROs with inflated structures (and costs) that surely
can still serve a set of substantial clients but no longer fits to
serve small biotechs, pharma companies and healthcare
start-ups given their very particular needs in terms of costs,
flexibility, sense of urgency and attention.
Unlike most CROs, our key driver is not related to short-
term financial goals. However, long-term customer
satisfaction and we bring that to daily life through the way
we shape our KPIs, quality control strategies, and risk-
based thinking in everything we do. Another element that
brings our unique mindset to life is the fact that we have
made a conscious decision not to have a business
development/sales team.
Whenever clients reach out to us looking for our services,
they get to talk directly with our team of medical doctors,
pharmacists, nurses, biologists who will be directly
involved in the client´s clinical trial/project, most of whom
have been on clinical development for 15, 20+ years.
At the end of the day, science comes first in everything we
do so that we can achieve our mission of "helping health
innovation reaching patients faster."
Shed some light on your offerings and how they impact
the CRO industry as well as your clients. How your
company provides research services to various
organizations?
The value we add as strategic partners to our clients is
much more a result of our focus on the "how" rather than on
the "what." We are equipped to provide end-to-end planning
solutions, conducting and reporting clinical trials from site
10 Most Innova ve CROs To Watch In 2023
JANUARY | 2023 20

Our values are built upon
elements that are key to
delivering operational
excellence with a high focus on
the human aspects that make a
difference in how we deliver it
daily.
feasibility and selection to project management, regulatory
submissions, risk-based monitoring, data management,
statistics, medical writing, among others. However, the
means we utilize to deliver are essential.
We are very meticulous when it comes down to
understanding what delivery methods can fit each client
better so that we can offer cost-effective solutions tailored
to each of them without having to choose between cost and
efficiency and without trying to push "over the top"
solutions only to justify we have them.
Tiago M D da Silva
Managing Director
JANUARY | 2023 21

While we rely on state-of-the-art tech solutions to plan and
manage trials efficiently, our secret sauce is our people, no
question about it. As we like to say, Clinergy is all about
"humanology and technology for high-performance clinical
development."
What are the core values upon which Clinergy Health
Research is built? What is the vision and mission of your
organization?
Our values are built upon elements that are key to
delivering operational excellence with a high focus on the
human aspects that are effective in how we deliver it daily.
They are a sense of urgency, entrepreneurship, efficiency,
caring for others, integrity, and passion.
We all know how hard and costly it is to put health
innovation into the hands of those who needed it, and, as
scientists, there is nothing more disappointing than
inefficiencies playing a role in that. Our mission of "helping
health innovation reaching patients faster" reminds us that
we should always be acting as catalysts so that we add real
value to the innovation chain.
Mr Tiago, please tell us about your professional tenure
in the CRO Industry.
Before founding CLINERGY, I have fulfilled different
clinical operations roles, including leading the Global
Clinical Research Operations for medicinal products within
a UK-based FTSE 100 consumer health company.
I had the pleasure to spend the last 17 years driving and
delivering strategic projects for companies such as
Novartis, Abbott, Eli Lilly, and Reckitt Benckiser, helping
patients have access to value-adding medicines and health
innovation across multiple geographic locations.
Having lived and worked in both hemispheres on either side
of the Atlantic, I have acquired an intimate appreciation of
the cultural and regulatory differences that truly impact
global clinical research.
Being an experienced leader, share your opinion on how
modern technologies have impacted the CRO sector.
How has Clinergy Health Research incorporated such
technologies into its daily operations?
Clinical development has benefited a great deal from new
tech solutions over the past 15 years, most notably over the
past decade. CROs have a key role in making innovative
solutions available to their clients by utilizing data-driven
solutions to reduce operational complexity, make better-
informed decisions around study design, monitor workforce
assignment, and conduct remote trials.
At Clinergy, we can embed various levels of technology
according to each trial´ needs, from eTMFs that count on
machine learning to automate document filling to high-tech
risk-based study execution solutions that cave save up to
40% of monitoring costs.
What would be your advice to budding entrepreneurs
who aspire to venture into the CRO space?
Setting yourself to be able to act as a partner to companies
that operate in one of the most regulated environments out
there is no easy task; people should know. The most
important point I would highlight to those considering
entering this space is: to make sure the core values which
you believe will set our company apart from other players
are genuinely embedded in daily operations. All the rest is
easily available to anyone else. In an expensive and
complex market such as clinical development, the cost is
certainly not part of the top three decision factors for most
companies as they know how much more expensive it could
be to have an entire clinical trial failing due to operational
flaws compared to paying a bit more to have a partner who
can deliver high standards by their side.
How do you envision scaling your organization's
operations and offerings in 2022 and beyond?
We have a clear view when it comes down to our growth
expectations. Although the demand is very high, we have
no interest in growing at any cost as we know the dangers
that come with that. We suffer no external pressure to
deliver better financial results every quarter as a privately
held company. That allows us to entirely focus on customer
satisfaction based on high-quality and high-performance
output as key drivers. We have been growing steadily, and
we plan to keep a close eye on the balance between growth
and excellence.
JANUARY | 2023 22

Oscar Juan
MD, PhD, Medical
Oncologist, Senior
Medical Manager
Pivotal S.L
JANUARY | 2023 24

ene therapy has evolved from being science fiction
Gto becoming a reality with the possibility not only
for treating hereditary diseases but also for treating
genetically complex diseases, such as cancer.
Gene therapy can be defined as the set of techniques that
use nucleic acids (DNA, RNA, or their variants) to replace,
correct, or inhibit an endogenous gene in the cells of the
organism or, acting independently of the gene, use a nucleic
acid to synthesize proteins or enzymes that provide new
biological properties to cells or tissues. The objective of
gene therapy is to treat or alleviate a disease.
Depending on the target cells on which we´d want to act,
we can differentiate two kinds of gene therapy:
• Germ gene therapy, which is the insertion of the
therapeutic gene in germ cells, such as egg cells in females
and sperm cells in males. Since this therapy alters the germ
cells, finally, the changes move on to the next generation.
This type of therapy could be used to definitively correct
congenital diseases. However, this has not been done in
humans due to its greater complexity and, especially, due to
ethical considerations.
• Somatic gene therapy, the objective of this therapy is to
introduce or alter genes in somatic cells, i.e., the cells that
make the body tissues of multicellular organisms. These
changes are not transferred to a person´s offspring.
In Vivo and Ex Vivo Gene Therapy
Depending on how we manage genes, we can differentiate
two types of somatic gene therapy:
Ÿ In vivo gene therapy: the therapeutic nucleic acids are
introduced directly into the patient’s body. The vector-
gene construct is introduced by cell-specific direct
injection into tissue in need. Once inside the body and
in contact with the targeted cells, the gene is
incorporated into the tissue’s cells, encoding the
production of the needed protein. In vivo gene therapy is
less complex than in vitro gene therapy. However, in
general, there is less control over the transfection of the
gene and its efficacy.
Ÿ Ex vivo gene therapy involves extracting the cells from
the system, isolating them, growing them in a culture,
and inserting the genes. Afterwards, cells are returned to
the body in a similar procedure such as those used in
hematopoietic stem-cell transplantation. Ex vivo gene
therapy has the advantages of allowing to choose the
cell type, having more control over the procedure, and
having greater efficacy in gene transfection. However,
its complexity is higher than in vivo gene therapy, has
an increased cost, and can only use cells that can grow
in culture.
Delivery strategies for therapeutic applications
The goal of gene therapy is to achieve a durable expression
of the gene transfected to correct the gene alteration that
causes the disease. A safe, effective, and controllable
delivery system is key in gene therapy. There are two types
of vectors: viral vectors and non-viral vectors.
Viral vectors
Viruses are, so far, the most used delivery strategy. The
advantages of viral vectors are the availability of well-
established protocols, high transduction efficiencies, and
Gene THERAPY
and Cancer
Treatment
JANUARY | 2023 25

Aboutthe
Author
Oscar Juan, MD, PhD, Medical Oncologist,
Senior Medical Manager at Pivotal S.L.U.
Oscar is MD from Universitat de València, Spain
(1991) and trained in Medical Oncology and
Haematology at Hospital Clínico Universitario
de Valencia, Spain (1995). He also holds a PhD
Cum laude from Universitat de València (2002).
He has been working as Medical Oncologist
since 1996 in various hospitals in Spain and
most recently at Hospital Universitari i
Politècnic La Fe in Valencia, Spain.
He has participated as Principal Investigator in
more than 100 international trials including
pivotal trials than have changed the clinical
practice and paradigms in lung cancer
treatment.
As a member of the Biomarker and Precision
Medicine Unit, he was focused on
metabolomics, epigenetic and genomic
biomarkers in EGFR-mutated lung cancer
patients and patients receiving immunotherapy.
He joined Pivotal in January 2020 as Senior
Medical Manager in Oncology. He focuses on
supporting the strategic clinical development of
new molecules and acts as the medical
reference and medical monitor for several
innovative early phases trials and provide
guidance to the Clinical Project team members
at Pivotal to ensure adherence to study
objectives and timelines.
JANUARY | 2023 26

having mechanisms for introducing genetic material into
cells systematically. Viral vectors include retrovirus,
lentivirus, adenovirus, and adeno-associated virus (AAV).
Retroviral vector was the earliest used and has a minimal
risk of causing insertion mutations.
Non-viral vectors
Non-viral vectors can carry a higher genetic load, are safe,
and generally induce a lower immune response. The
liposome is one of the most attractive non-viral vectors for
gene therapeutics. Liposome has no inhibition and no
significant damage to normal tissues and cells around the
target cells, enabling the target gene to be fully transfected
into the target cells. After the success of SARS-CoV-2
vaccines, lipid nanoparticles have become a widely used
vector for gene therapy.
Gene therapy in monogenic diseases
Gene therapy was initially conceived as a treatment of
genetic diseases caused by mutation of a single gene
(monogenic). Hereditary diseases include various disorders
in which a defective gene determines that a protein is not
synthesized or is elaborated abnormally, causing many
different clinical manifestations depending on the structural
or enzymatic function of that particular protein (e.g.,
hemophilia A). These problems could be solved with gene
therapy by supplying a normal copy of the defective gene to
the affected tissues.
Approaches in Cancer gene therapy
Cancer occurs due to the disruption of normal cell
proliferation and apoptosis processes. The aim of gene
therapy in cancer is different from the treatment of
monogenic diseases in which the goal is to correct a specific
genetic defect.
Several gene therapy approaches have been developed for
cancer management, such us:
Ÿ Oncolytic Virotherapy (OV) is one of the most
promising approaches for tumor immunotherapy. OV
introduce wild-type tumor suppressor genes into cells
that lack the tumor suppressor gene leading to tumor
cells’ lysis inducing an anticancer immune response
(e.g., p53 gene).
Ÿ Gene silencing therapy uses an RNA interference
(RNAi) that induce sequence-specific degradation of
complementary mRNA. RNAi is used in different areas
of medicine, such as neurodegenerative and
cardiovascular diseases, viral infections, and cancer.
Since cancer is the accumulation of various mutation
types that regulate gene networks promoting cell
proliferation, RNAi is an attractive approach to treating
tumors.
Ÿ Suicide gene therapy consists in introducing suicide
genes to express enzymes or proteins that directly
trigger the death of tumor cells (the gene encodes a
protein that is cytotoxic) or indirectly (the gene
expresses enzymes that are sensitive to a drug that is
administered concomitantly).
Ÿ Chimeric antigen receptor (CAR)-T cell therapy is a
slightly different process with respect to the more direct
forms of gene therapy. CAR-T cells are a lab-generated
fighter cells customized for each individual patient.
They are made by collecting T cells from the patient and
re-engineering them in the laboratory adding anti-cancer
genetic code to produce proteins on their surface called
chimeric antigen receptors, or CARs. These CARs
recognize and bind to specific proteins, or antigens, on
the surface of cancer cells.
CAR-T cell therapies are the most common technology
used in potential cancer therapy and represent 49% of the
genetically modified cell therapies pipeline. However,
CAR-T cell therapies can cause severe side effects being the
most frequent and serious one the cytokine release
syndrome (CRS).
To date, the FDA has approved several CAR-T cell
therapies for hematological diseases. However, challenges
remain for the use of CAR-T cell therapy to treat solid
tumors due to their heterogeneity and localizations in the
human body.
Conclusions Drawn
Gene therapy represents a novel therapeutic approach for
managing diseases with difficult treatment. Monogenic
diseases have been treated successfully with gene therapy,
but cancer is a complex process in which cells have altered
their normal proliferation and apoptosis. Recent progress in
developing safe and effective vectors for gene delivery,
understanding gene editing, and the advances in adoptive
immunotherapy with CAR-T cells has opened up new
avenues and strategies for treating intractable diseases.
JANUARY | 2023 27

ost COVID-19 pandemic world has
Pcompletely changed. The impact is most
severe on the healthcare industry, especially
on the clinical research and trials activities across the
globe. The life science industry met unprecedented
challenges which forced it to accelerate innovation,
revamp its traditional mindset and embrace digital,
virtual and online capabilities to ensure service
continuance.
Traditionally, the Industry was very cautious, slow
and reticent in adopting digital and virtual clinical
trial practices. It was comprehensible, evident and
expected since many of the device-dependent
diagnosis and treatment driven therapeutic areas
added much more complexity to the digital, virtual,
and remote oﬀering evolution. Further, already
established, proven, and existing decade old practices
could not be abandoned or replaced or shifted to the
digital, virtual or remote mode.
This emerged as the major concern in the continuance
of clinical research and trial niche, leading to almost
87% reduction in clinical research in England during
the peak time of ﬁrst wave, as later found out by
University College London study. Answering the
question of avoidance, the industry opened up its
mindset to accept the changing realities of clinical
trials and shifting nature of clinical research in the
post-pandemic world.
Role of
CROsin
Shaping the
of ClinicalResearch
Future
JANUARY | 2023 28

Redeﬁning
Advancements
JANUARY | 2023 29

The Changing Dynamics of Clinical Research Industry
A rapidly growing industry, clinical research and trials is
advancing due to new studies conducted in record numbers,
ever-increasing patient participation expanding the clinical
trial subject pool, numerous research sites of excellent
quality, and a huge volume of successful trials over the
years contributing to the expertise and values. Further
development of technical modules and various modalities
could improve clinical trial continuance and drive
innovation and change to the higher level.
However, all these modalities and modules must meet the
standard criteria’s and benchmarks of excellence so that the
safety and security of the trials could be maintained or
enhanced. This is where digital, virtual, and remote
technologies could aid in optimizing various processes like
site feasibility, pre-screening of patients, selection and
clinical trial providence.
By reviewing its own trends, changes, pressures, upheavals,
successes and failures during the last two and a half years,
the clinical trial industry managed to come up with more
than a dozen coronavirus vaccines, thus pushing forward
the innovation driven momentum and accelerating the
renewed focus by considering key factors of success.
Tech-Focus:
With many of the restrictions still being in effect, industry’s
digital mindedness is continuing. Simply, the industry has
now fully adopted an entire decentralized virtual model
attitude or a hybrid approach. In this new approach,
organizations are compelled by the virus to continue with
the clinical trial modalities which can offer at-home or
remote testing facilities along with online practices and
digital techniques. It will ensure clinical trial continuance
for patients in a more comfortable, convenient, safe and
secure manner. This will be done without any negative
impact on the clinical investigators participation.
During the last two and a half years remote pre-screening
tests, e-consent practices and monitoring approval by
patients and clinicians is on the rise. Since they are now
established as preliminary benchmarks for future
modalities, the industry could further leverage
advancements in practices best suitable and feasible across
the entire spectrum of life science industry to further drive
safe, secure, flexible, patient-centric, comfortable,
convenient, and efficient clinical research and trial
modalities which will constantly keep improving the future
performance of clinical trials.
It will provide a primary foundation for the both hybrid
modelled and fully virtual research and trial environments
which will be completely equipped with precise tools,
adequate techniques, robust and seamless infrastructure, a
well-integrated ecosystem, and big-data analytical
methodologies.
Creating Streamlined Ecosystem:
When cross-functional entities work jointly, all the related
stakeholders could participate in offering inputs, gaining
information, and mutually assessing the developmental
approaches to increase the result acceptance amidst the
changing market dynamics. This is crucial when deriving
digital, virtual and remote clinical trial effectiveness
assessment.
As they have easy access to patients, clinical investigators,
sites, and sponsors, partners of Clinical Research
Organizations(CROs) can promptly facilitate further
enhancements in digital, virtual and remote clinical trials
conductions success.
Futuristic CROs Transforming the Clinical Research
Before the pandemic happened not any expert would have
been able to predict the future of healthcare industry forget
of clinical research and trial industry. Although the
pandemic is unprecedented in its devastation, one thing it
did good is the way it diverted the entire progress path of
sector world over.
The possibilities, opportunities, and probabilities it has
opened up is an unimaginably positive future in itself. The
journey has merely started. We could push the boundaries
of now established innovation further. This way we could
explore some unexplored areas in the clinical trials with
many CROs coming together and creating an upbeat
ecosystem which will operate like an industry organ which
will facilitate a future where globally innovative modalities
could be established, enhanced and advanced so that
whenever any unprecedented crisis situation will arrive in
the future, the industry as a whole and the world as united
will be able to combat.
-Anish Miller
JANUARY | 2023 30

OnQ Research
Blend of Innova ons Assuring Adaptability
linical trials are carried out by contract research
Corganizations (CROs) for the pharmaceutical,
medical device, and biotechnology businesses as
well as for academic institutions, governmental agencies,
and foundations. Using a CRO for outsourcing reduces the
amount of time needed for clinical trials and product
development.
When compared to conducting the trial internally, working
with a CRO frequently results in significant time savings.
The tools and resources needed are already available to
CROs, and they also have a staff of internal experts with
experience in all facets of clinical testing, development, and
compliance.
With more than 20 years of experience, OnQ Research is a
full-service contract research organization (CRO). It is
dedicated to offering pharmaceutical, biotech, other CROs,
and allied businesses innovative, affordable, and useful
clinical research services. OnQ Research was established in
1999 and has since carried out more than 500 clinical trials
in southern Europe and more than 10 African nations.
Without the chance to incorporate other African nations,
South Africa cannot be viewed in isolation. Mozambique,
Botswana, Rwanda, Ghana, Uganda, Kenya, and Tanzania
are just a few of the African nations where OnQ Research
has conducted extensive research. This entails assessing a
new region and assisting in the creation of full-fledged,
qualified clinical research sites through site evaluation and
resource and capacity building. Success in all clinical trials
on the African continent is guaranteed by its distinctive
Clinical Monitoring Team concept and clinical study
approach. The company is known for producing
high-quality research quickly and effectively.
Clients can centralize research across Africa with the help
of OnQ. Due to its extensive expertise and experience, it
can provide excellent patient care, lower risk, and superior
data management. OnQ's clinical research team is spread
across all of the major cities in each nation, allowing it to
be flexible and deploy resources as needed.
Under the adept leadership of Catherine Lund, the
Founder and Managing Director, OnQ Research offers
Catherine started her clinical research journey as
a study coordinator for an RSV trial. She then
joined IQVIA (then Quintiles) as a clinical trial
assistant in 1996 and trained to become a CRA.
She started consulting in 1999 and gradually
evolved the business into a CRO. She describes
herself as an accidental entrepreneur and grew
the team and processes as the demand grew.
Catherine Lund is the Founder and Managing
Director of OnQ Research. She is, by training, a
registered neonatal nurse who entered the
clinical research arena as a research nurse,
followed by her formal clinical research training at
Quintiles. She left Quintiles to pursue a career in
contracting.
Through collaborations, she then established
OnQ Research, initially as a consultancy, which
evolved into a full-service, South African-based
CRO in 1999. Catherine Lund has served on the
SACRA (South African Clinical Research
Association) Exco for a period of three years.
She was the Vice Chair for the South African
Chapter of ACRP (Annual Review of
Competency Progression) in 2003.
Catherine Lund is a registered nurse with a
diploma in general, midwifery, community health,
and psychiatry, a certificate in neonatal intensive
care, and a BA in diplomacy and political studies
from B.G. Alexander Nursing College and
UNISA, respectively.
The Adept Leader
10 Most Innovative CROs to Watch in 2023
JANUARY | 2023 32

Catherine Lund
Founder and
Managing Director
OnQ Research

top-notch clinical trial management and coordination
through CRAs with regional bases in all major cities in the
nations it operates in. This ensures close site management
and reduces costly travel expenses. It is perfect for all of its
clinical trial management needs due to its significant
experience in carrying out successful trials.
Below are highlights of the interview that emphasize OnQ’s
services to assist with the entire continuum of clinical
research.
Catherine, please brief our audience about your
company, its USPs, and how it is positioned as a reliable
name in the CRO sector?
OnQ Research is a South African-based, organically grown
CRO servicing primarily the African continent. OnQ
Research prides itself on offering its clients a blend of
innovation, adaptability while adding real value with our
highly trained staff. We use science as the basic premise for
our services without compromising on quality.
OnQ Research does not have a “one size fits all” approach.’
This applies to all aspects of the client relationship and
interface, from budgets to sizes of teams, systems and
processes offered, and levels of engagement.
Shed some light on your offerings and how they impact
the CRO industry as well as your clients. How your
company provides research services to various
organizations?
We offer assistance with protocol inception and design,
liaising and obtaining appropriate Health Authority and IRB
approvals, selecting high quality sites through our extensive
networks, project management, monitoring, data
management, and medical writing.
What are the core values upon which your organization
is built? What is the vision and mission of your
organization?
Our core values are Empowerment: We empower emerging
biotech and pharma companies with tools, resources, and
expertise for clinical trial execution. Internally, we also
apply the same value. We are passionate about career
growth and offering potential candidates opportunities to
add value to our organization. Collaboration: OnQ
collaborates with sponsors and clients to drive cost-
effective delivery of clinical trials. Quality-focused. We are
committed to the ethical conduct of clinical trials and
delivering quality data for drug registration.
Being an experienced leader, share your opinion on how
modern technologies have impacted the CRO sector.
How has your company incorporated such technologies
into its daily operations?
We make use of carefully selected, fit-for-purpose systems
for day-to-day clinical trial management. We use a CTMS
for project management tracking and are in the process of
implementing a locally developed learning management
system and quality management platform. As our company
grows, the implementation of new technologies is crucial to
improving efficiencies. Still, it requires careful risk-benefit
considerations to ensure that we remain capable of
delivering a high-quality product at a competitive price.
What would be your advice to budding entrepreneurs
who aspire to venture into the CRO space?
Although I am, of course, biased, this is one of the most
exciting industries in which to venture. Networking is key.
Attending as many conferences as you can and accessing as
much information as you can. Understand what part of the
CRO space excites you and where you can see your future
path.
How do you envision scaling your organization’s
operations and offerings in 2023 and beyond?
Our company is very deliberate in its focus on being the
premier CRO in Africa. Our plan to achieve this is to be
intentional about investing in our staff and understanding
that all our clients require a bespoke and unique service.
Please give us a few testimonials of your
clients/customers and a list of awards/recognitions that
accurately highlight your organization’s position in the
market. (If available/permissible)
Our clients consistently offer similar feedback in that they
enjoy working with our organization, which is flexible,
adaptable, and up for any challenge. It has been broadly
indicated that we have a “can-do” problem-solving
approach to conducting clinical research without
compromising on quality outcomes.
OnQ Research prides itself
on offering its clients a blend
of innova on, adaptability
while adding real value with
its highly trained staff.
JANUARY | 2023 34

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