Vendor Selection and Risk Mitigation in Accordance with ICH E6 (R2)

-Transitioning from Required Minimum to Sustained Compliance and Scalability

Are your outsourcing practices structured to gain the maximum efficiency and ROI that it could be?  This brief article on Vendor Selection and Risk Mitigation in Accordance with ICH E6 (R2) will provide a perspective on how compliance can be utilized to establish a better vendor experience.

Biotech companies face increased regulations that require documentation of their vendor selection process, vendor oversight, quality practices, and risk management strategies.  These regulations present an optimal opportunity to establish standardization that drives efficiency and consistency. 

ICH E6 (R2) Guidelines impact on Sponsors

In 2017 the ICH recognized a need to modernize the E6 guidelines and supplement with recommendations to facilitate the implementation of new methodologies and increase the quality and efficiencies in clinical trials, referred to as ICH E6 (R2).  This revision included a new section, section 5.0, which addresses all activities of the clinical trial life cycle, from design to archiving.  These revised guidelines provided new definitions and clarity around Sponsor responsibilities.   

Many companies still seem to struggle with effectively executing a standardized process for selection, contracting, oversight and management of vendors (CROs, etc.)  Prior to this revision expectations for vendor selection/management or risk management were not documented. 

What are the Sponsors new responsibilities?  Section 5.2.2 states: “The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).”  Although this statement is vague and is expected to be further clarified in the upcoming revision 3, many believe this infers that the sponsor now has the obligation to have a documented practice in place that describes its process for vendor selection and vendor oversight. 

This is often best accomplished through outsourcing and contracting SOP’s.  Contracts should also reflect that prior to use of third parties by CROs, sponsors should be informed and assured the selection process and oversight are in compliance.  The vendor oversight processes should have a vendor management plan linked to the outcome of risk assessment. 

The implementation of a sound vendor management plan, starting with the vendor selection process, will result in ICH E6(R2) compliance and enhance the sponsor/vendor relationship by establishing a means of frequent and structured way to communicate, set expectations and success criteria while mitigating risk. A good vendor selection process should include:

• Request for Information (RFI) and Request for Proposal (RFP) templates

• Bid Defense Meeting

  • Score card

• Contracting

  • Transfer of Obligations (need to submit to FDA, should be included in contract)

• Quality Assurance

  • Vendor Qualification

  • Vendor Audits

• Vendor Oversight

o   Third Party Oversight Plan

o   Governance

• Metrics/KPIs

• Project Management Plan

• Monitoring Plan

• Data Management Plan

• Statistical Plan

• Site/Patient Recruitment Plan(s)

• Risk Management

  • Risk-based quality management

  • Risk-based monitoring

  • Risk-based provider oversight

    • Governance

    • RACI

    • Communication Plan

• SOPs

These practices should be established and implemented prior to initiating the clinical development of a product.  Be careful not to over-complicate the vendor infrastructure.  Smaller, less complex vendor infrastructures tend to make for a smoother path towards execution.  Organizations lacking the internal expertise to develop a robust, compliant, vendor selection process should consider seeking out an outsourcing subject matter expert (SME) as either a full-time resource or as a consultant.

When selecting the best outsourcing model and strategy keep the end in mind. 

• Are you taking your product through the entire clinical development program to marketing? 

• Are you only interested in limited clinical development with the intent to sell or license out to a larger company to complete late phase development and/or to file for regulatory approval and finally to market? 

Your end goal, along with available funding will determine your best option.  If your interest is in positioning your product to sell or license, it would be advantageous to establish processes and strategies commensurate with ICH E6(R2) practices before embarking on the clinical development of your product to not only realize the ROI associated with it but also to offer your potential buyers a more robust, comprehensive, well organized and GCP compliant “package” which would presumably add value to the offering.

As part of your outsourcing strategy, keep in mind that relationship building is a critical component to all successful vendor outcomes.  It takes clear communication and collaboration to strengthen those relationships.  This starts to take root prior to and throughout your vendor selection process.  When developing your outsourcing strategy, assess your internal capabilities, identify your gaps, consider costs versus speed along with determining the impact of your choices on your long-term goal.  This help you decide whether or not to contract temporary resources, utilize Function Service Providers (FSP) for certain services, contract a full-service provider, or to develop a hybrid approach.

Mark Mann is a Principal Consultant for The Oxenham Group and an accomplished executive with extensive experience in drug development, and driving programs to successful completion, resulting in product approvals by directing clinical operations, outsourcing strategies, and clinical development with leading pharmaceutical and medical device companies.

To schedule a discussion with Mark and his team, or to learn more, please click here.