Executive Summary
Operational Delivery
General Pharma Company is pleased to provide our proposal to Sample Pharma, Inc. (hereafter referred to as Sample Pharma) for the conduct of your
upcoming Phase III XYZ study on the safety and efficacy of
Sample Drug on a General Indication entitled:
A
Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the
Safety and Efficacy of Sample Drug Compared with
Sample in Adult Patients with General Indication
In our proposal your General Pharma Company team has outlined why we
will be the ideal partner for Sample Pharma. We have provided information regarding
overall experience in General Indication studies;
addressed the operational execution of the XYZ study; and provided a
budget based on given study parameters, General Pharma Company’ assumptions, and risk based monitoring approach. In addition, we have
responded to all RFP questions.
For the execution of this study General Pharma Company will provide the
following services:
- Clinical project management
- Project initiation and start-up
- Feasibility
- Clinical monitoring and site management
- Quality assurance
- Medical monitoring services
- Vendor management (Central Lab)
- Drug Safety
- Data management and analysis
Upon receipt of your RFP documents we assembled our team of medical, clinical
project management and site start-up (SSU) experts to determine the most appropriate
country/site strategy. Our proposed strategy involves 14 countries, and
multiple regions based on previous experience we have in studies conducted in General Indication,
and from extensive global feasibility previously performed. We are confident
that given the current clinical landscape and lessons learned from similar
studies, this approach offers a realistic, initial strategy. In order to
optimize site fit and recruitment performance we suggest completing a more
thorough feasibility upon study award to further refine our recommendations.
General Pharma Company’s Key Advantages
General Pharma Company has undertaken over 185 Phase I-IV General Indication studies involving approximately 236,000
patients in 79 countries worldwide in the past three years. General Pharma Company has extensive
experience in recruiting patients in intensive care settings, and believe that
this experience will be pivotal to the successful completion of this Phase III
study.
Global Reach and Local Expertise
General Pharma Company unrivalled global reach and size positions our company uniquely in
terms of single provider ability to fulfill all development functions globally. Our worldwide presence gives us access to
exceptional patient populations in less developed countries, and allows us to
utilize the low cost structure in emerging economies to deliver highly
competitive services. Operational efficiencies are enhanced by our ability to
manage large, global and multifunctional teams with globally harmonized
systems, practices and SOPs. By building
the right local relationships, having a comprehensive understanding of local
laws and sensitivity to local customs, we can find you the right investigator,
with the right patient, in the right country.
Strategic Partnerships and Networks
General Pharma Company partnerships and clients include key relationships with providers
and healthcare organizations, clinical specialty associations, patient
organizations, hospital associations, pharmacist associations, managed care
organizations, state departments of public health, Quality Improvement
Organizations (QIOs) and government agencies.
Operational Talent
We
are delighted to be able to offer Sample Pharma Company an extremely experienced study team,
led by our Global Clinical Project Manager (gCPM) John Doe. Based in Idaho,
John is a Director within the General Indication Group and has successfully managed a
number of large project teams in his career at General Pharma Company. He will have primary
global clinical project management responsibilities for your study and be the
main point of contact for the Sample Pharma Company team following an award.
Medical Expertise
We
have a highly experienced medical team with extensive expertise in General Indication studies. Mary Jane, M.D., will assume the role of
Medical Advisor for your XYZ Sample study. Dr. Jane has a unique, strong combination
of extensive training and experience as Director of Medical and Scientific
Services in the General Indication. Dr. Jane understands the specific requirements of
treatment in this indication and will collaborate closely with the team to
provide medical oversight. Dr. Jane, like John, is based in Idaho.