1. REACH CLOSER to the Truth
EmpiriStat, Inc.
2011 Corporate Capabilities Summary
BIOSTATISTICAL SYNERGY
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
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2. Corporate Capabilities Summary
REACH CLOSER to the Truth
Quick Facts About EmpiriStat, Inc.
Woman-Owned Small EmpiriStat was founded with a unique goal: to discover the truth as far as
Business possible. As biostatisticians and clinical trialists, we believe reaching this goal is
only possible by going beyond analytics. For every research and development
Federalwide Assurance
(FWA) A00015488 project, science and fact extend along a timeline in both directions—past,
present and future. Applying rigorous methodologies and experience at every
CAGE Code: 53F97
point along this timeline results in outcomes that are as close to the truth as
DUNS Number: 826391034 possible.
Small Business NAICS codes:
518210 541519 541611 Our work lies at the intersection of science and practice. We bring in depth
541690 541712 541720 experience to your research and development, along with accurate
541990 611420 611430 documentation, rigorous quality control, and regulatory compliance. We work
efficiently under tight project deadlines without compromising quality.
EmpiriStat, Inc. Professional
Development and Training We work with clients interested in ongoing communication and dialogue
Education and training is the between disciplines and our experience comes from collaborating with many
cornerstone of EmpiriStat. researchers over a wide range and complexity of studies in epidemiology and
Without the tools for continuous various medical and device specialties. We are committed to providing and
improvement professionally and maintaining the highest scientific rigor and ethical standards—while providing
personally, we believe we lose both timely and cost-effective services.
the insight, knowledge, and
passion to further ourselves,
our career, and our business. Commitment to Excellence
Training is the process of We at EmpiriStat are committed to “We have the passion for making
developing specific skills to building long lasting collaborative things happen with an urgent
perform a certain job or task relationships with our clients. We believe
more efficiently, and education patience, optimism, and a tolerance
that to forge these effective relationships,
is noted to be the overall we must remain true to our key values: for uncertainty. It is not just the
development of the human responsibility, integrity, value, and respect for our knowledge in the
mind. EmpiriStat offers a wide
commitment to excellence in every role field that we possess, but taking
range of specific training
sessions, such as Good Clinical and task we undertake. action and doing valuable work
Practice (GCP) training, Site with that knowledge.”
Management Training, or Data Our underlying foundation at EmpiriStat is
and Safety Monitoring Board a belief that we can make a difference in
~ Dr. Nicole C. Close, President
(DSMB) Training. We also offer the world and we will try to do that each
a wide variety of Professional and every day. We have the passion for
Development courses, such as making things happen, coupled with a genuine reserve of good will, from
Educational Modules in professionals who are excited to share and contribute their knowledge and
Biostatistics for Non-
experience, but who are equally compelled to learn and to engage themselves
Statisticians, Epidemiology,
in that process to continually improve corporately, professionally and
Data Management, and
Pharmacovigilance. Please personally.
contact us to request a
Professional Development and
Training Brochure.
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
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3. SELECTED CASE STUDIES Services
Challenge: A pharmaceutical We offer the following major clinical research collaboration and services:
company was only months away Biostatistics and Statistical Programming
from filing their NDA with the Data and Safety Monitoring Board Services
FDA. They did not have an in-
Project Management
house Biostatistics/Statistical
Programming group for review
Statistical Software and Programming Validation
and writing of the ISS SAP and Clinical Data Management
to conduct the validation Clinical Site Management
programming for their program. Clinical Monitoring Services
Safety Monitoring and Reporting Services
Statistical Analysis: EmpiriStat
collaborated with the company Regulatory Support Services
and provided all of the services Scientific Administrative Support
required as the Sponsor’s in- Biostatistical Synergy
house Biostatistics and Statistical
Programming group to support
both the ISS and the NDA filing
within a very condensed
Biostatistics and Statistical Programming
timeframe without compromising EmpiriStat provides a wide range of services throughout every project and
quality. clinical trial phase. Some services – such as statistical programming of tables,
listings, and figure shells – provide cost and time savings to our collaborator if
Result: The company received
the Biostatistical guidance,
programmed and validated while the trial is
writing, review and statistical ongoing (instead of during the database closure and
validation programming from analysis phase). The range of our assistance can be
EmpiriStat to complete the filing categorized loosely by project/trial phase
within the existing company (Implementation, Ongoing, Database Closure,
timelines. The company saved Analysis, Post Clinical Trial, and General) and range
time and money by consulting from hypothesis, objectives and endpoint planning, Protocol and Statistical
with EmpiriStat who provided Analysis Plan writing/review, Sample size/power calculations, Statistical
flexible, time efficient and cost programming specifications, to Interim data monitoring/analysis, Database
effective services in an expedited
review and cleaning, and Primary statistical analysis and secondary review of
manner set by the client’s needs.
statistical analysis and interpretation.
Challenge: The client had
contracted with EmpiriStat for
Data and Safety Monitoring Board Services
part-time Senior Clinical and Establishing, managing, and participating on a Data and Safety Monitoring
Regulatory Affairs Management Board (DSMB) is a serious process. EmpiriStat has the skills, knowledge, and
and expertise. The client was experience to perform DSMB services professionally and effectively. As a
also in the process of contracting partner in the process, we assist the Sponsor in DSMB member identification
for a full service CRO to provide and selection, DSMB training, and full administrative support services. Our
Data Management, Clinical professional management and secure data analysis and delivery ensures
Monitoring, Safety Reporting, leadership to assist with establishing the objectives, responsibilities, and
Biostatistics, and Regulatory
procedures through an official charter. We also have the expertise to establish
support for their multi-center
clinical trial. However, the client
procedures for the review of safety data, and we are fully qualified to act as
was having contracting the unblinded partner in performing the statistical analysis and facilitation of
difficulties and the trial timelines the exchange of information between the DSMB members, DSMB Chair, and
were being delayed. Sponsor.
Solution: EmpiriStat was
contracted by the client to
expand their current services to
provide a Bridge until the CRO
could be selected and
contracted. In a condensed
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
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4. timeline of just 4 months,
EmpiriStat created the
Project Management
deliverables and provided the EmpiriStat has the experience and capability to succeed at collaborating and
on-site professionals to initiate managing overall projects and clinical trials beyond statistical services. We
the clinical trial (including have the ability to provide critical leadership across the entire project team,
complete Case Report Forms, and we work with the sponsor to complete deliverables and strive to meet
Manual of Procedures, a Safety project timelines and budget specifications. Our Project Management support
Reporting System, Study Specific will guide your study with seamless communication that will define and
Procedures, Establishment and complete your project on time, and on budget. Some of our PM services can
procedures for a Data and Safety include “hands-on” oversight from concept to completion, coordination and
Monitoring Board, all training
review of project deliverables such as Protocols, CRFs, and other clinical study
modules, Clinical Monitoring Plan
and 2 certified research tools, and study budget forecasting and contract negotiation. We also develop
coordinators and one Risk Analysis Plans, Outsourcing Plans, and Contingency Plans to reach your
professional consultant). A clear project milestones.
transition plan was developed
between EmpiriStat’s Bridge of Statistical Software and Programming Validation
services to the CRO.
Validation is a critical element in clinical trials, and EmpiriStat provides
Result: The client moved valuable insight for the entire validation process, including assistance with
forward with the deliverables validation procedures and documentation of statistical software installation,
required to initiate the trial
operation and performance qualification, SAS® Macro and statistical
without further delay, had no
programming validation, and independent review and assessment of corporate
cost or delay associated with a
new group getting up to speed statistical software validation procedures, processes and documentation.
on the trial since EmpiriStat was
currently providing management Clinical Data Management
guidance. It saved time and
Effective and well-executed data management is a vital part of any project or
money when the CRO was hired
since all primary deliverables had
clinical trial, and EmpiriStat’s Data Management services
been created for the study. ensure the quality of your results. EmpiriStat is capable
of providing full data management services to include the
design and review of case report forms, Data
Challenge: A European device Management Plans, and the development of edit
company was preparing for filing specifications. We also have the ability to develop and
with the US FDA with a device implement a clinical database to collect and store study data, and perform
already approved in Europe. medical coding using MedDRA and WHO Drug dictionaries. EmpiriStat is proud
They had consulted with an to be capable of supporting studies that are paper-based, electronic, or a
academic Biostatistician in the
hybrid of both.
US, but were unsure of the
analyses and recommendations
that the Biostatistician had made Clinical Site Management
and was looking for an Selection, evaluation and qualification of clinical sites and investigators are
independent senior statistical
critical for the successful execution and completion of clinical trials. The site
opinion.
selection process and the relationship of the sponsor-site-investigator are key
Solution: EmpiriStat was areas of opportunity in accelerating the drug and device development process
consulted to review the while generating high quality data. Site selection is a crucial decision that
statistical analyses and needs to be made by the Sponsor in which both obvious and underlying
recommendations and to provide
challenges are addressed and efficiencies are made. Considerations we take
their own assessment prior to
the company filing. EmpiriStat
into account are the potential of patient recruitment and retention; the
statisticians (PhD Biostatistician experience of the site Principal Investigator, quicker start-up processes, the
with US Regulatory experience increased competition among Sponsors for sites, patients, increased
and an EmpiriStat UK Statistical globalization of trials and key players, and FDA and international regulations.
Consultants versed in EMEA EmpiriStat assists the Sponsor in creating site selection and management
guidances) reviewed the processes by taking an in-depth look at specific steps and/or a critical analysis
information and provided a of existing practices, challenges and provide an opportunity to formulate a
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
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5. detailed Statistical Risk Analysis more solid partnership between Sponsors, sites and investigators.
of the filing.
Result: The device company Our team has successfully implemented clinical trial sites, and we have proven
was provided with a detailed processes for starting new sites that remain lasting ones through in-depth
Statistical Risk Analysis training, education and continual mentoring.
summary and an independent
assessment. The company made
modifications to their filing based
Clinical Monitoring Services
upon EmpiriStat’s Frontline attention to detail and quality comes from well-developed clinical
recommendations and monitoring plans and their appropriate execution. EmpiriStat embraces the
successfully filed with the US philosophy that the biostatistician and data manager works with the clinical
FDA. monitor in those plans in order to provide insight into key variables and issues
of data collection and recording that may have an impact on the final analyses.
Early identification prevents issues later and saves staff time and costs. We
Therapeutic Experience
assist our collaborators with expertise in quality assurance of study operations,
writing and implementing clinical monitoring plans, monitoring reports, as well
 Infectious Diseases
 Vaccines as protocol and regulatory compliance review.
 Traumatic Brain Injury It’s our standard to have a very short turnaround time for issuing our reports.
 Transplants and Immunology
Something we take great pride in and have been commended on by many of
 Anti-Infectives
our clients.
 Reproductive Health
 Medical Devices
 Dermatology Safety Monitoring and Reporting Services
 Blood Products
EmpiriStat offers a comprehensive plan to help you manage your pre- and
 Wound Care
post-marketed product safety program. This management and services may
 Oncology
 Diabetes
include Serious Adverse Event (SAE) and Adverse Event (AE) reporting, SAE and
 Cardiovascular Disease AE MedDRA coding, examining current treatment utilization patterns, SAE
narrative writing, submission to regulatory authorities, generation of
MedWatch (3500A/CIOMS) Forms, preparation of periodic safety update
Global Depth and Diversity
reports (PSURs) and periodic adverse drug experience reports (PADERs. We
follow the FDA's Good Pharmacovigiliance Practices and EMEA's European
 Government Directive 2001/20/EC guidelines and focus our work-products on the end-user
 Non Profit Organizations perspective.
 Private Industry For those studies that require use of an Independent Safety Monitor, our
 Academic
EmpiriStat Consultants stand ready to perform those functions as well, safely
partitioned and fire-walled from our Safety Department and project staff.
 Private Practices
Regulatory Support Services
“I would do anything for Empiristat. You EmpiriStat offers tailor made regulatory services to assists Sponsors and
can trust them to do what they say they
Investigators with the administrative activities involved in meeting the
will do, which isn’t always true about
contractors. They have a sense of
regulatory requirements for research involving human subjects. We can
urgency and their work is top-notch. assure that study projects and protocols comply with federal, state, and
The fact they are a virtual company institutional requirements governing the conduct and implementation of each
never entered my mind because they trial, and can serve as a liaison between the FDA, the IRB, Investigators, and
always deliver—and in this economy, Research Staff. Additionally, we can offer consultation and guidance regarding
that is what it most important.” the application to the FDA regarding your product or device, support for FDA
and IRB submissions, assistance with registering trials on ClinicalTrials.gov,
~Roger House, President assistance with Pre-IND meetings, Type B Meetings and other regulated
Axiom Corporation meeting requests, and guidance for FDA audits.
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
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6. Scientific Administrative Support
Often it is necessary to provide scientific administrative support for a project
that may not have a dedicated individual to perform these services, or does
not have a sufficient amount of this work to employ a full-time staff member
to handle. This often results in these services being assigned to members of
the team with other duties. With competing projects, timelines, and efficiency
in mind, EmpiriStat recognizes these challenges and provides the following
services to support your team: Administrative management of Data and Safety
Monitoring Boards, preparation and distribution of paper and electronic
documents, on-site management of local or international conferences, and
For personalized attention coordination of Investigator kick-off meetings. Also provided are the
contact us at: coordination and scheduling of science team meetings, and taking minutes
during these group collaborations.
EmpiriStat, Inc.
13694 Sam Hill Drive
Mount Airy, MD 21771
Biostatistical Synergy
Tel: 866.935.STAT derived from the Greek synergos, συνεργός meaning working together
Fax: 866.276.STAT
Email: info@empiristat.com Synergy is when two or more different entities cooperate advantageously for a
final outcome. We think with EmpiriStat’s teamwork, we will help you
produce an overall better result than if you were working toward the same
goal individually. We take pride in our ability to provide the highest quality
services with an appropriately staffed team while maintaining our
responsiveness and flexibility of a smaller company. It’s a promised standard
from us that includes expertise, mentoring, and support from a team of
experts who understand your needs. Our goal is always to help you succeed by
working as a part of your team. We will tailor a project plan to meet the needs
www.empiristat.com
of every project, whether you need full scope global services or only one
particular service, such as statistical analysis and programming. It is our
absolute goal to help you succeed by fully integrating and working as part of
your team.
“I’d heard Empiristat would be a good company to handle our
statistical analysis. They were very patient while we waited for
regulatory clearance, then incredibly fast and efficient when
clearance finally came. Their data cleaning was nothing short of
amazing, and when I asked them on short notice to write some
abstracts for conferences, I was blown away by how quickly this
was done—and they were extremely well-written. I can’t say
anything bad about Empiristat.”
~Mark Breda
Makerere University School of Medicine
Kampala, Uganda
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com 
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