10-12 October 2018
The eXL Clinical Quality Oversight Forum was attended by over a hundred professionals representing drug and device sponsor firms and suppliers. The theme of trial integrity was presented across a variety of topics with a focus on assessment of quality. All attendees agreed that investing in collaborative, cross-functional, risk-based decision making/planning is the best was to ensure quality and compliance (quality by design).
We heard several presentations about recent global agency inspection experiences. Seems agencies are increasing their sponsor inspections, with one (1) firm reporting an inspection every month in 2018 (China, MHRA, EMA and local MoHs). Inspection trends included electronic access to e-systems (e.g., TMF, EDC) for pre and post inspection periods (up to six  months), emphasis on randomization protection and Risk Management Plans. e-system access is in contrast to the US FDA activities who do not plan request remote access as part of an inspection any time soon as noted by Miah Jung, the US FDA speaker from the Office of Compliance, CDER.
Ms. Jung presented the 2017 inspection metrics which cite historically consistent observations from 57 Sponsor, 18 CRO and 79 IRB inspections. She anticipated that 2018 would have less Warning Letters issued to Sponsor firms than in 2017. She went on to emphasis her desire for the US Form 1572 for foreign sites which surprised many attendees in light of direct guidance from agencies (e.g., Germany) not to complete the form. She verbalized an expectation that site personnel undergo GCP training “every few years” and while the agency does not inspect the CRO’s vendors, it is expected that Sponsor has oversight of all vendors, including those contracted by the CRO (perhaps through oversight of the CROs oversight program). Inspectors have been trained on ICH E6 R2 and expect to see Risk Management Plans, where the Sponsor provides the scientific risks, the CRO the operational risks and all stakeholders are involved early on (before the final protocol), including Biostatics. She also stated that new guidance publication is imminent related to e-systems and e-records.