Are your outsourcing processes compliant with current and new requirements?
The Sponsor remains ultimately responsible for a clinical study's conduct. Regulatory inspections increasingly examine sponsors' oversight and control of both large and small scale outsourced activities
MHRA GCP Guidelineswww.gov.uk/guidance/good-clinical-practice-for-clinical-trials ....MHRA would also like to remind sponsors that they are ultimately responsible for GCP. Therefore, sponsors have a requirement to ensure oversight of all staff working on their trials, including contractors.... (MHRA Infringement notice remarks, 2016)
OM360 can install and implement the oversight processes expected by regulatory authorities.
Assessment of existing processes
Actions in response to audit reports or inspections regarding vendor oversight & control
Integration of OM360 QA validated SOPs into sponsor Quality Management System
Search & Selection
Scope of Work & Setup
Governance & Oversight
Training of outsourcing processes & tools for operational staff
ICH GCP E6(R1) 5.2.1 A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.....
Current ICH E6 (R2) Amendments include significantly increased expectations:
Management & oversight of Investigator Sites ( Section 4.2.5/4.2.6/4.9.0)
Sponsor Quality Management responsibilities (entire new Section 5.0)