Birds-of-a-Feather Round Table Discussion:  Suppliers/Venders Oversight: Best Practices

Date:  Thursday, 17-March-2022      Duration: One hour (Note: this is the “odd” week so please see exact time in each time zone below)

Facilitator:           Manuela Hornberger, Boehringer Ingelheim   

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic:   A sponsor is obligated to keep oversight of vendors/suppliers involved in clinical trials (and related activities). It sounds easy, but it actually is not. There are so many different types of vendors, ranging from software suppliers, SaaS providers, service providers (e.g. CRO, adjudication, ..). 
- What exactly is required to keep and demonstrate oversight?
- Is it sufficient to have 'adequate contracts' in place, do audits every now and then and that's it?
- What is your experience or learning from the last years with increasing outsourcing?
- Do you feel like everything is 'under control' and that oversight can be demonstrated at all times (during and after the trial) in a way acceptable by regulators?

- What is your perspective from vendor/supplier side on the topic?

- Are their ‘standard processes’ in place at the vendor/supplier side to support the oversight activity of the sponsor or is it required to re-invent the wheel with every new sponsor because they are having different expectations?

This session is not intended to provide answers to the above questions. It is about exchanging views with other participants and gaining insights into the different parties’ challenges and needs. This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion.

Time – Please note the time … it is during the “odd” week when North America and Europe are one hour “less” apart than usual.  Because this is a Round-table discussion, as per eCF policy it will not be recorded. If you cannot make it, please ask a colleague to attend for you. We apologize for the inconvenient time in some time zones.

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

eCF Members may register using this link:   eCF BoF Round-table Registration (eclinicalforum.org)