Protocol for Oversight of BA/BE Study Sites and Monitoring Activities Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for clinical monitoring and site management activities…
Procedure for Administering Investigational Products in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and accurate administration of study drugs…
Protocol for Management of Investigational Products in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling, storage, and accountability of study…
Procedure for Randomization and Masking in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the randomization and blinding processes in Bioavailability (BA)…
Standard Operating Procedure for Managing Vendors and Third Parties in Clinical Research Purpose This SOP outlines the procedures for the selection, engagement, oversight, and evaluation of vendors and third parties…
Standard Operating Procedure for Identifying and Managing Conflicts of Interest in Clinical Research Purpose This SOP outlines the procedures for identifying, assessing, and managing conflicts of interest (COI) in clinical…
Standard Operating Procedure for Managing Emergencies in Clinical Research Purpose This SOP outlines the procedures for emergency preparedness and response in clinical trials and clinical studies. The goal is to…
Standard Operating Procedure for Maintaining Participant Confidentiality and Privacy in Clinical Research Purpose This SOP outlines the procedures for ensuring the confidentiality and privacy of participant data in clinical trials…
Standard Operating Procedure for Compensating and Reimbursing Participants in Clinical Research Purpose This SOP outlines the procedures for compensating and reimbursing participants in clinical trials and clinical studies. The goal…
Standard Operating Procedure for Managing and Mitigating Risks in Clinical Trials Purpose This SOP outlines the procedures for risk management and mitigation in clinical trials and clinical studies. The goal…