As Sponsor, you’re responsible for ensuring adequate oversight of every organisation who provides services for your clinical trial. For example: investigator sites, IMP manufacturers and distributors, pharmacovigilance service providers, clinical research organisations, vendors and laboratories.
Paul Cross Consulting can assist by providing vendor oversight services on your behalf. PCC will complete the following work plans on behalf of the sponsor organisation:
During study set-up: feasibility review, protocol and essential documentation development (Patient Information Sheets and Consent Forms, IMP Dossiers, Investigator Brochures), management and oversight of the Research Ethics Committee (REC) and Clinical Trial Authorisation (CTA) applications, management of the Sponsor Green Light process, and implementation of risk management processes (risk assessment and risk mitigation).
During the conduct of the research study: management of quality control and quality assurance, GCP audits.
Vendor oversight will commence during the study set-up and will continue during and after the study’s completion; to ensure the study is managed in line with GCP and The Regulations.
*Please note, all work is completed virtually at the current time, due to the Covid-19 pandemic.
Contact PCC for further information: firstname.lastname@example.org