Category: Professional Posters
Purpose: Pfizer Worldwide Research, Development and Medical’s (WRDM) mission is to deliver breakthrough medicines that change patients’ lives. As clinical trials for investigational products (IP) continue to grow in complexity and scope, it is critical that biopharmaceutical companies and clinical trial sites work collaboratively to strengthen the IP handling experience for both healthcare providers and patients. A need for clinical research pharmacy expertise was identified to enhance this partnership with external stakeholders.
Methods: Clinical Research Pharmacy (CRP) was established at Pfizer to partner with clinical sites to maintain data integrity, ensure regulatory compliance and protect patient safety. An initial gap analysis identified an opportunity to improve the IP handling experience at clinical trial sites. Subsequently, the CRP team conducted clinical site visits globally. These visits provided Pfizer colleagues an opportunity to engage in conversations regarding clinical site operations and local pharmacy practices related to IP handling. In addition, the CRP team has taken the initiative to invite clinical site personnel to Pfizer in order to gain an understanding of IP operations and processes.
Results: Two patient-focused initiatives, Site Awareness and Visit Exchange (SAVE) and Site Practices and Opinions Round Table (SPORT), were implemented. These two initiatives identified five areas of focus related to IP handling. They are 1) optimization of IP handling documentation; 2) access to “end-user (healthcare provider and patient) friendly” clinical trial supplies and supplemental tools (e.g. videos); 3) provision of IP handling training through investigator meetings and clinical site initiation visits; 4) consultation on clinical site IP handling related matters and 5) development of innovative mobile applications to enhance IP handling experience for clinical sites.
CRP has created an IP manual with detailed handling instructions for use by the clinical trial sites. Patient/caregiver dosing instruction cards and site administration instructions are provided to assist on the proper use of IP. CRP provides enhanced IP handling training at investigator meetings/clinical site initiation visits and serves as a key resource for clinical site IP queries. CRP was instrumental in the deployment of two mobile applications designed to minimize dispensing errors and notify clinical sites of pending IP shipments.
Conclusion: CRP at Pfizer is an innovative and novel organization that was created to enhance the IP handling experience and optimize the conduct of Pfizer-sponsored clinical trials.