1. REACH CLOSER to the Truth
EmpiriStat, Inc.
2010 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

2. Corporate Capabilities Summary
REACH CLOSER to the Truth
Quick Facts About EmpiriStat
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
project, science and fact extend along a timeline in both directions—past,
Federalwide Assurance present and future. Applying rigorous methodologies and experience at every
(FWA) A00015488
point along this timeline results in outcomes that are as close to the truth as
possible.
CAGE Code: 53F97 Our work lies at the intersection of science and practice. We bring over 15 years
DUNS Number: 826391034 of experience to your research and development, along with accurate
Small Business NAICS codes:
documentation, rigorous quality control, and regulatory compliance. We work
efficiently under tight project deadlines without compromising quality.
518210 541519 541611
541690 541712 541720
541990 611420 611430 We work with clients interested in ongoing communication and dialogue
between disciplines and our experience comes from collaborating with many
researchers over a wide range and complexity of studies in epidemiology and
various medical and device specialties. We are committed to providing and
maintaining the highest scientific rigor and ethical standards—while providing
both timely and cost-effective services.
Commitment to Excellence
EmpiriStat Launches 2010 We at EmpiriStat are committed to building “We have the passion for
Boot Camp Training Series long lasting collaborative relationships with making things happen with an
Our 2010 Boot Camp Training Series was our clients. We believe that to forge these
developed by professionals who have urgent patience, optimism, and
effective relationships, we must remain
hands on experience in all phases of clinical a tolerance for uncertainty. It is
research. Training Series include true to our key values: responsibility,
educational modules for Biostatistics, Data integrity, value, and commitment to not just the respect for our
Management and Standards, excellence in every role and task we knowledge in the field that we
Pharmacovigiliance and Safety Reporting, undertake.
Clinical Monitoring and Data and Safety possess, but taking action and
Monitoring Board Training. Each course is doing valuable work with that
presented once per Quarter at specific Our underlying foundation at EmpiriStat is
locations and is offered on-site or at a a belief that we can make a difference in knowledge.”
central location designated by the client. the world and we will try to do that each
Facility and meeting planning for a central
and every day. We have the passion for ~ Dr. Nicole Close, President
location may be arranged by an EmpiriStat
Meeting Planner Manager on behalf of the making things happen, coupled with a genuine reserve of good will, from
client. Please contact us to request our professionals who are excited to share and contribute their knowledge and
Training Brochure. experience, but who are equally compelled to learn and to engage themselves
in that process to continually improve corporately, professionally and
personally.
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

3. SELECTED CASE STUDIES
Challenge: A pharmaceutical Services
company was only months away We offer the following major clinical research collaboration and services:
from filing their NDA with the
FDA. They did not have an in- Biostatistics and Statistical Programming
house Biostatistics/Statistical Data and Safety Monitoring Board Services
Programming group for review Project Management and Auditing
and writing of the ISS SAP and Statistical Software and Programming Validation
to conduct the validation Clinical Data Management Assistance
programming for their program. Site Selection and Qualification
Solution: EmpiriStat Clinical Monitoring
collaborated with the company Safety Monitoring and Reporting Services
and provided all of the services Scientific Administrative Support
required as the Sponsor’s in-
house Biostatistics and
Statistical Programming group Biostatistics and Statistical Programming
to support both the ISS and the EmpiriStat provides a wide range of services throughout every project and
NDA filing within a very clinical trial phase. Some services – such as statistical programming of table,
condensed timeframe without listing, and figure shells – provide a cost savings to our collaborator if
compromising quality. programmed and validated while the trial is
Result: The company received ongoing (instead of during the database closure and
the biostatistical guidance, analysis phase). The range of our assistance can be
writing, review and statistical categorized loosely by project/trial phase
validation programming from (Implementation, Ongoing, Database Closure and
EmpiriStat to complete the filing Analysis Phase, Post Clinical Trial Phase, and
within the existing company
General) and range from hypothesis, objectives and endpoint planning, Protocol
timelines. The company saved
time and money by consulting
and Statistical Analysis Plan writing/review, Sample size/power calculations,
with EmpiriStat who provided Statistical programming specifications, to Interim data monitoring/analysis,
flexible, time efficient and cost Database review and cleaning, and Primary statistical analysis and secondary
effective services in an review of statistical analysis and interpretation.
expedited manner set by the
client’s needs.
Data and Safety Monitoring Board Services
Establishing, managing, and participating on a Data and Safety Monitoring
Challenge: The client had Board (DSMB) is a serious process. EmpiriStat has the skills, knowledge, and
contracted with EmpiriStat for experience to perform DSMB services professionally and effectively. As a
part-time Senior Clinical and partner in the process, we assist the Sponsor in DSMB member identification
Regulatory Affairs Management
and selection, DSMB training, and our professional management and secure
and expertise. The client was
data analysis and delivery ensures leadership to assist with establishing the
also in the process of
contracting for a full service CRO objectives, responsibilities, and procedures through an official charter,
to provide Data Management, expertise to establish procedures for the review of safety data and we are fully
Clinical Monitoring, Safety qualified to act as the unblinded partner in performing the statistical analysis
Reporting, Biostatistics, and and facilitation of the exchange of information between the DSMB members,
Regulatory support for their chair, and Sponsor.
multi-center clinical trial.
However, the client was having
contracting difficulties and the
trial timelines were being
Project Management and Auditing
delayed. EmpiriStat has the experience and capability to succeed at collaborating and
managing overall projects and clinical trials beyond Biostatistical services.
Solution: EmpiriStat was Many clients find our management capabilities an invaluable aspect of our
contracted by the client to
larger collaboration. Our management services include project leadership and
expand their current services to
management of clinical trials, epidemiologic studies, health surveys, and
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

4. provide a Bridge until the CRO surveillance studies; Auditing of vendor facilities and services for statistical
could be selected and analysis, programming and Computer system 21 CFR Part 11 compliance
contracted. In a condensed qualification and auditing.
timeline of just 4 months,
EmpiriStat created the
deliverables and provided the
on-site professionals to initiate Statistical Software and Programming Validation
the clinical trial (including
Validation is a critical element in clinical trials, and EmpiriStat provides valuable
complete Case Report Forms,
Manual of Procedures, a Safety insight for the entire validation process, including assistance with validation
Reporting System, Study procedures and documentation of statistical software installation, operation
Specific Procedures, and performance qualification, SAS® Macro and statistical programming
Establishment and procedures validation, and independent review and assessment of corporate statistical
for a Data and Safety Monitoring software validation procedures, processes and documentation.
Board, all training modules,
Clinical Monitoring Plan and 2
certified research coordinators Clinical Data Management Assistance
and one professional Effective and well-executed data management is a vital part of any project or
consultant). A clear transition clinical trial, and EmpiriStat’s guidance of clinical data
plan was developed between management ensures the quality of your results. Such
EmpiriStat’s Bridge of services services include design and review of case report forms,
to the CRO. write and review Data Management Plans and edit
Result: The client moved specifications, design data entry structures appropriate
forward with the deliverables for clinical and laboratory data and provide edit specification programming and
required to initiate the trial validation. New in 2010, EmpiriStat is showcasing their paper reduction data
without further delay, had no collection technology “EmpiriSource.”
cost or delay associated with a
new group getting up to speed
on the trial since EmpiriStat was Site Selection and Qualification
currently providing management Selection, evaluation and qualification of clinical sites and investigators are
guidance, and will save time and critical for the successful execution and completion of clinical trials within
money when the CRO is hired budget and timelines. The site selection process and the relationship of the
since all primary deliverables sponsor-site-investigator are key areas of opportunity in accelerating the drug
have been created for the study.
development process while generating high quality data. Site selection is a key
conscious decision that needs to be made by the Sponsor in which both obvious
Challenge: A European device and underlying challenges are addressed and the opportunities for improving
company was preparing for filing efficiency are made. Considerations we take into account are the potential of
with the US FDA with a device patient recruitment and retention; the growing scarcity of experienced
already approved in Europe. investigators who bring relevant experience to your trial, quicker start-up
They had consulted with an processes, the increased competition among Sponsors for sites, patients and
academic Biostatistician in the experienced investigators, increased globalization of trials and key players, and
US, but were unsure of the FDA and international regulations. EmpiriStat assists the Sponsor in creating
analyses and recommendations the process, taking an in-depth look at specific steps and/or a critical analysis of
that the Biostatistician had
existing practices, challenges and provides an opportunity to formulate a more
made and was looking for an
independent opinion. solid partnership between Sponsors, sites and investigators.
Solution: EmpiriStat was Clinical Monitoring Services
consulted to review the Frontline attention to detail and quality comes from well-developed clinical
statistical analyses and
monitoring plans and their appropriate execution. EmpiriStat embraces the
recommendations and to provide
philosophy that the biostatistician and data manager works with the clinical
their own assessment prior to
the company filing. EmpiriStat monitor in those plans in order to provide insight into key variables and issues
statisticians (PhD Biostatistician of data collection and recording that may have an impact on the final analyses.
with US Regulatory experience Early identification prevents issues later and saves staff time and costs. We
and an EmpiriStat UK Statistical assist our collaborators with expertise in quality assurance of study operations,
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

5. Consultants versed in EMEA written and implementation of clinical monitoring plans, on-site data audits and
guidances) reviewed the monitoring reports, and protocol compliance and regulatory compliance
information and provided a review.
detailed Statistical Risk Analysis
of the filing. Safety Monitoring and Reporting Services
Result: The device company
EmpiriStat offers a comprehensive plan to help you manage your pre- and post-
was provided with a detailed
marketed product safety program. This management and services may include
Statistical Risk Analysis
summary and an independent SAE/AE Handling, Adverse event (AE) and serious adverse event (SAE) data
assessment. The company entry and logging, examining current treatment utilization patterns, AE and SAE
made modifications to their filing evaluations, SAE narrative writing, literature reviews and summaries,
based upon EmpiriStat’s Regulatory Reporting, Generation of MedWatch 3500A/CIOMS forms,
recommendations and preparation of periodic safety update reports (PSURs) and periodic adverse
successfully filed with the US drug experience reports (PADERs), and prompt notification of potential
FDA. expedited IND, alert, and suspected unexpected serious adverse reaction
(SUSAR) reports. We follow the FDA's Good Pharmacovigiliance Practices and
EMEA's European Directive 2001/20/EC guidelines and focus our work-products
on the end-user perspective.
Industries We Serve
Government For those studies that require use of an Independent Safety Monitor, our
Biotech EmpiriStat Consultants stand ready to perform those functions as well, safely
Pharmaceuticals partitioned and fire-walled from our Safety Department and project staff.
Neutraceuticals
Academic
Vaccines 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
For personalized attention
mind, EmpiriStat recognizes these challenges and provides the following
contact us at:
services to support your team: Administrative management of Data and Safety
Monitoring Boards, Prepare and distribute paper and electronic documents,
EmpiriStat, Inc. Arrange and provide on-site management of local or international conferences
13694 Sam Hill Drive and Investigator kick-off and training sessions, Schedule conference calls and
Mount Airy, MD 21771
meetings and taking minutes at scientific meetings and during conference calls.
Tel: 866.935.STAT
Fax: 866-.276.STAT
Email: info@empiriStat.com
Biostatistical Synergy
derived from the Greek synergos, συνεργός meaning working together
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
www.empiristat.com
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 of every project. Whether
you need full scope global services or only one particular service offering like
statistical analysis and programming.
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