1. Where Do We Come From? What Are We? Where Are We Going?
Planimeter Kft, Budapest, Hungary
OUR MISSION
is to serve as a source of expertise in delivery classical and
up-to-date biostatistical services in pharmaceutical, bio-
technology, medical device industries world-wide, and to
promote the use of rigorous quantitative methods in the
biomedical and public health sciences. Our approach is to
capitalise on our presence and network in Hungary and use
information technology to assist the life sciences industry in
the development of quality products, on time and on budg-
et, every time.
OUR VISION
is to be an internationally known and accepted ser-
vice provider in Pharmaceutical industry. One day we
would like to turn our rich knowledge and experience
in biostatistical / bioinformatical innovation. What we
do not aim at any circumstances is to be‘leader’in
business or measurements aspects. We wish to pro-
vide top-level services with a manufactural taste and
comfort.
PLANIMETER
is a full service CRO specialised in Translational
Medicine.
Our biggest strength is the strong mathematical and
data management background. During our 16 years
history we took part in all phases of drug develop-
ment including pre-clinical and post-marketing. The
company today has 16 employees and a similar pool
of contractors.
CONTACT
Managing director: István Jánosi
Address: Váci út 95,
Budapest, Hungary,
H-1139
Tel./Fax: +36 1 452 0545
E-mail: janosi@planimeter.hu
Web: www.planimeter.hu
REFERENCES
Big Pharma: AstraZeneca (HU, RO, BG), Abbott (HU,
HR), UCB (HU, CZ, A), Novartis, Pfizer, Sandoz, Roche.
Medium-sized Pharma: Allergopharma (D), Actavis,
EGIS, HYD (HU) Novo Nordisk (HU, SRB, LV).
CRO:
Argint (H),
Msource (B), Ac-
covion (D),
NorthWiseSer-
vices, Cerafor,
Russlan (UK),
Clinovo (USA).
PARTNERS
We are grateful to:
• Argint International, a Hungarian CRO with rich
experiences in monitoring and site management
especially in Hungary
• Cerafor, a UK CRO with whom we analysed many
Phase III, and integrated safety studies together
• Infomatix, a Hungarian IT company who trained
Spotfire us
• Russlan Clinical, a UK CRO operating in former
Soviet countries.
eCRF / EDC
Planimeter developed its own eCRF concept
and the system operates in 8 countries now.
• Monitoring sup-
port
• Full query man-
agement
• Complete audit-
trail
• Easy and self-evident patient management
• Wide range of tools to support of data entry and
correction
• Flexible reporting options
• 0-24 telephone help-desk.
Current references are: Astrazeneca (H, RO, BG),
UCB (H, A, CZ, SK), Abbott (H, HR, RO), Boehringer
Ingelheim (H, A, SL, SK).
Furthermore four oncological patient registry was
also designed and implemented in Hungary.
Patient Support Program
Patient Support is about integration and share
of information in trials with educational con-
tent.
- Integration of GPs,
specialists, call-centers,
education websites and
patient organisations,
- Notifications to partic-
ipants on visits or other
requirements,
- Measure and report
the impact of the edu-
cation on the outcome
and compliance.
Statistical Analysis of IMS-data
Our solution supports (scientific) statistical
analysis of IMS-
data.
• Flexible group-
ing,
• Several pre-de-
fined analytical
tools (time-series
approach, pat-
tern identification, intervention analysis),
• Direct reporting on inter- or intranet,
• Integrated hypothesis testing tools,
• Wide variety of graphing opportunities.
Design and evaluation of Trials
Core service covering all aspects of Trials from
design till reporting.
Data / Text Mining
Data and text mining are important and effec-
tive tools both in handling of“Big Data”and
Translational Research.
We already successfully completed several data-
text mining projects. We are familiar in gaining in-
formation from publicly available databases (like
clinicaltrials.gov) and we also apply these tech-
niques during reporting from IMS-database.
We designed, built and explored data warehouses
for many companies in pharma and finance sec-
tors.
Besides SAS® we are also familiar with
Personalised Treatment
Translational Research, handling
of big data results personalised
treatment.
Our current experiences in personal-
ised treatment are connected with
- comparison of safety profiles of
clinical and post-marketing phase
- investigation of genotyping vari-
ants
- performance of subgroup analysis
to detect specific non-responders.
Handling of Big Data
Analysis of“big data”gives not only more re-
sults. It gives another perspective.
Exploration of complex integrated databases re-
quires a different skill set than evaluation of stud-
ies.‘Classification tree’,‘clustering’,‘spatial analysis’,
‘time series’, just to highlight some frequently used
techniques. There are more differences in explora-
tory data analyses compared to study data report-
ing: a) research question is generally not postu-
lated in formal mathematical language b) (partly
consequently) generally no unique answer can be
given (e.g. in a classifica-
tion).
Furthermore the new tasks
require new tools, too. Our
favourite tools are WEKA,
KNIME, R and WINBUGS.
1997 2013201120031999 2001 2005 2007 2009
“Give me
six hours
to chop
down a
tree and
I will
spend the
first four
sharpen-
ing the
axe.”
(Abraham
Lincoln)
> 120
Clients
> 350
Trials
> 500,000
Patients
> 20
eCRFs
• Protocol, CRF, SAP, table shell development
• Management of submission
• Database structure according to CDISC standards
• Statistical programming (in SAS or R) with a well-
established QA-support
• PK/PD-modeling
• Application of new ap-
proaches (Bayesian-meth-
ods, BUGS, modeling with
WEKA, etc.).
Rich experiences in Phase
I-IV and post-marketing stud-
ies, and epidemiological surveys. The therapeutic
areas we are most familiar are: vascular and ner-
vous system disorder, ophthalmology, infections,
oncology, renal and urinary disorders, immuno-
logy and respiratory disorders.
Data Management
100% error free databases from both electronic
and paper sources.
• Our data clerks are dedicated to clinical trials
Highly sophisticated and detailed QA-system
• Complete query management
• Full audit trail
• Follow of CDISC-standards
• Being CFR21 Part 11 compliant.
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