This document provides information on Precision Clinical Research Group (PCRG), a clinical research organization. It summarizes PCRG's services, which include clinical trial monitoring, training, and customized tools and standard operating procedures. It emphasizes PCRG's focus on accuracy, detail-orientation, and ensuring clinical trials are conducted according to high standards.

1. CP
R
G
PRECISION
CP CLINICAL
R Claudette Palmer, PA, RN, FNP, has over 17 years experience in the
G management of clinical trials for the pharmaceutical/biotech and medical
device industry and a background in protocol and CRF design, drug accounta- RESEARCH
bility design/procedures, investigator recruitment, budget negotiations, field
monitoring and remote data entry. GROUP
Lori Richards has 15 years in the Biotechnology and Pharmaceutical
industries from basic research to Clinical Program Management. Ms. Richards
has developed protocols, CRFs, negotiated contracts/budgets, performed
audits, and managed clinical activities of Phase I-III clinical trials. Her
expertise is Oncology Therapies. She has a BS degree from Southern Illinois
University.
who
we
are Lisa Sanchez-O’Brien is a Clinical Research Assistant and was responsi-
ble for all clinical administrative management for Jenner Biotherapies, Inc.
prior to joining PCRG. Her expertise includes monitoring incoming data from
clinical trials, preparation of all FDA submissions for ongoing studies, patient
drug assignments and coordinating Scientific Advisory Board and Principal
Investigator meetings.
Benjamin Gaines is president and CEO for PCRG. He has been a business
consultant with a focus on recruiting for Fortune 500 companies for more
than twenty years. His involvement in the Biotech industry since 1992
includes recruiting, business consulting, and contracting Medical Monitors,
Scientists, Clinical Research Associates, Bio-statisticians, and Data
Management personnel.
CRITICAL
minds
over
matters
P R E C I S I O N C L I N I C A L R E S E A R C H G R O U P
1980 Ocean Street Suite A Santa Cruz, California 95060-1723
CRITICAL
TEL 831-469-7416 FA X 831-469-7432 E M A I L Bgaines@precisionclinical.com
www.precisionclinical.com

2. P R E C I S I O N C L I N I C A L R E S E A R C H G R O U P
“ The difference and the
between a word
Some people have the ability to see the critical fine lines but overlook the whole as the
sum of the parts. PCRG’s attention to detail includes a broad view of the bigger picture.
We check and re-check every aspect of our research as well as the impact of smaller issues
exactly right word on the full scope of the project at hand.
is the difference Training
between lightning Pharmaceutical companies have traditionally been reluctant to conduct clinical trials in
certain foreign countries due to complexities of training or lack of training, as well as
and the lightning bug.
” regulatory oversight. With the adoption of the International Conference on Harmonization
and Good Clinical Practice Guidelines (ICH GCP), these countries have become increasingly
more attractive in the competitive rush to conduct global research programs.
how
do
we
MARK TWAIN
Training provided by PCRG is tailored to the specific need of the client and includes: business
• Extensive review of ICH GCP Guidelines
• Study preparation to include project management
• Clinical trial administration (CRA and Coordinator)
• Production of quality and reliability of data
PCRG at the Forefront of Global Research
What we do is inextricably linked with the emphasis we place on perfection. In our talks Since 1998 Pharmaceutical companies and CROs have been expanding to South Africa,
with existing and future clients, we have learned that, above all other concerns in the Russia and Spain where there are significant numbers of trained medical professionals.
what biopharmaceutical industry today, is accuracy of data. The final results are only as good as
the starting plan and how it is conducted.
These areas also offer large numbers of patients with racially specific diseases.
we
do Precision Clinical Research Group, Inc. (PCRG) provides its clients with reliable, accurate
and cost-effective reporting of clinical data using highly qualified, experienced and
PCRG provides training programs tailored to meet the International Committee of
Harmonization (ICH GCP) Guidelines in order to attract pharmaceutical companies to
these under-utilized areas.
accountable CRAs and Project Managers. Our total focus is the success of your clinical
program. We deliver the components of that success using strict, specific and accountable Clinical Site Management
guidelines that meet and match your high standards of operation.
Study sites must function like a well-oiled machine – always in compliance with GCP
One of the world’s most unmanaged challenges today is the lack of dedication to detail. guidelines and consistently meeting your high standards. Our CRAs are assigned to ensure
We see it on a global level in the forgiveness of miscalculations at every level. A 1% faithful adherence to protocol, from study start-up to site closeout. The CRA assigned to
margin of error may be allowable in matters of mundane importance but no intrinsic value your unique project, initiates and trains study site personnel, monitors the CRFs, audits
can be placed on a human life. regulatory files and resolves data queries. You receive a written report documenting the
findings and progress of each visit. Upon data retrieval, your database is audited to
Precision Clinical Research Group is self-regulating in matters of reliability. Our research is
resolve discrepancies. The result is a wholly verified and accurate data package.
exhaustive. Our ethics are scrupulous. Our results are exactly what you should expect and
must demand.
Optimum Precision
Precision Clinical Research Group knows, as you do, that the depth and scope of the final
data originates with the quality of the tools used to collect that data. The PCRG staff
carries through with its dedication to detail in building those tools to ensure that final
We start with the exactly right people. results adhere to the highest standards of reliability.
Mark Twain once said “The difference between a word and the exactly right word is the
where difference between lightning and the lightning bug.” We translate Mr. Twain’s observation
We customize the exactly right tools for your project by using and improving on estab-
lished methods that have been effective in the past. At the same time, we maintain a for-
we – with rigorous dependability – in our delivery of clinical monitoring and project manage- ward thinking attitude to allow for possibilities in new and innovative methods that might
begin ment services by carefully selecting the exactly right candidates for each project.
Each associate on the PCRG team is chosen to meet the specific demands and needs of
be appropriate for your specific project.
SOPs for study site reports, SAE Reporting and preparation are customized to fit your
your program. Associates must meet a stringent set of criteria, meticulously outlined by clinical program. Updates and reports on the status of accrual and status of each site are
PCRG’s management, before final assignment to a project. Experience on paper is not always provided on a regular, pre-determined basis.
enough. Our candidates must have a demonstrated track record of proven performance and
success with a clear commitment to and investment in perfection. Our carefully crafted set If it’s important enough to do it right, it’s important to do it exactly right. At the core of
of checks and balances ensures results and services originating with high standards and Precision Clinical Research Group’s philosophy and success is our rigorous adherence to
accountability. accuracy. Consistently. In this, we are inflexible.