© 2018 by STEP-IN Management Ltd.

Supplier Oversight: company and study level

Few Life Sciences companies conduct all their work in house.  The activities that are considered core has reduced to strategy and approval (and for some areas, e.g. regulatory submission and CSRs, not even that).

 

What always remains is sponsor accountability and the ICH E6 R2 Addendum of 2017 shows regulators recognise this needs improvement. Although the R2 Addendum gives encouragement for risk based approaches, the requirement to have robust processes to establish and document oversight at study level is clear.

 

Due diligence for the selection of suppliers and their ongoing management is an aligned activity and in scope for inspection

‚Äč

Oversight Plans content should point to study Risk Management Plans, acknowledge transition of work to new suppliers, allow for revision to reflect the maturity of relationship and encourage early data-driven remediation of issues.

STEP-IN Management Associates help clients establish Supplier Selection and Management SOPs and tools and have worked with Clinical Teams to create, populate and align study- and function-specific practical Oversight Plans for CROs.