White Guide – Chapter 9: Pfizer-Sponsored Research
and Clinical Research Collaborations (CRCs)
Rev. 2/23
Page 146 of 381
Chapter #9: Pfizer-Sponsored Research and Clinical
Research Collaborations (CRCs)
Pfizer engages scientists, Healthcare Professionals (HCPs), academic and other research institutions,
for-profit co-development partners, as well as government agencies to conduct research and
development projects and studies. These include in vitro experiments (discovery), in vivo studies
(preclinical animal), human clinical studies, and consultancies and services related to these areas. This
research can generate important information about Pfizer products as well as valuable medical and
scientific information that can lead to improvements in clinical care, the development of new treatments,
and better delivery of healthcare to patients.
Pfizer-sponsored clinical studies are frequently a key part of the development of medicinal products and
devices. Pfizer-Sponsored clinical studies are designed, conducted, and overseen by Pfizer or on behalf
of Pfizer. When Pfizer is the sponsor, it is generally responsible for the regulatory obligations applicable in
the geographies where these studies are conducted. Pfizer-sponsored studies may be intended to support
a new product, a significant change in the labeling of a product, a new indication, a proposed advertising
claim, or post-marketing commitments. The company may engage the services of Contract Research
Organizations (CROs) or other service providers to assist in execution of some or all elements of clinical
trial conduct including study design, start-up, study management, data monitoring, data analysis, and
reporting. There are various types of Pfizer-sponsored clinical trials, which are covered by different SOPs,
CMCD CT02-GSOP Protocol Development for Interventional Studies, CMCD CT24-GSOP Non-
Interventional Studies and CMCD CT45-GSOP Interventional Studies With Minimal Risk. Contact the
Business Process Owners (BPOs) for information about these SOPs.
Clinical Research Collaborations or CRCs are engagements under which Pfizer collaborates with an
external party to perform a clinical study and/or other clinical research activities. CRCs allow Pfizer to
partner with investigators and organizations (Collaborators) to generate innovative research of potential
scientific value to patients, physicians and the greater scientific community. Collaborators may be academic
institutions, research networks, cooperative groups, government agencies or other entities. Pfizer may
provide Collaborator with one or more types of support, such as funding, product(s), device(s), equipment
or other types of support such as in-kind services like publication writing support, Pharmacokinetic (PK)
analysis, etc. In addition, Pfizer can contribute to the development of the protocol, Informed Consent
Documents (ICDs), Statistical Analysis Plan (SAP), and other relevant study documents. In certain
CRCs, Pfizer will want to obtain access to and/or request data to be transferred to Pfizer.
CRCs facilitated and managed by the Research Collaboration Center of Excellence (COE and/or R-CRC
team (part of GPD), that is part of the Global Medical Grants group, are subject to the requirements of