We recently concluded a highly productive, three-day face-to-face workshop for the IMPALA Critical to Quality Assessment Methodology and Report (CAR). The workshop was sponsored by IMPALA and hosted by Boehringer-Ingelheim in Ingelheim, Germany, and brought together the CAR work product team representatives from across our member companies. Our primary goal was to engage in focused discussions to define and finalize the implementation guidelines and associated toolkit that any Sponsor company can leverage to implement CAR methodology. 

The Regulatory Imperative

A focal point of the workshop was calibrating what is reported in Clinical Study Reports (CSR) for “Important” Quality Issues versus what was needed to ensure we meet ICH E6 R3 guidelines. The team fundamentally aligned that current mechanisms like the CSR do not fully enable a proactive, timely, and end-to-end story of quality oversight and management at relevant stages

 of a clinical trial. Establishing a clear IMPALA value proposition on how the CAR methodology enables sponsors to fulfil the regulatory expectations and align with these CSR requirements is critical to our strategy moving forward. 

 

Key Achievements 

The dedicated time allowed us to align on core principles and make significant strides on our deliverables: 

  • Industry Assessment: We developed a heat map documenting the current state of CAR implementation across the industry and highlighting its drivers. 
  • Barrier Identification: We discussed and documented specific pain points in implementing a CAR methodology so they can be factored directly into the guidelines and tools. 
  • Core Guidelines: The team made substantial progress on drafting the IMPALA Guideline and identified key elements of the CAR template to support Sponsors in implementing the CAR methodology. 
  • Data Mapping & Templates: We agreed on a close-to-final draft of the Critical to Quality (CtQ) Factors, definitions and objective questions. We also agreed on data mapping tools, alongside advancing the draft IMPALA CAR Template. 
  • Tool Integration: We reviewed existing IMPALA tools and analytics to identify what can be natively referenced in the CAR Guidelines. 
  • Value Proposition: We identified the need to document a comprehensive value proposition for both, internal and external stakeholders. This will prove invaluable in sharing it consistently across industry and regulatory agencies. 

  

Presenting to Boehringer-Ingelheim Leaders 

IMPALA was honoured to present the CtQ assessment methodology and report to leaders within Boehringer-Ingelheim. Jorge Lizardi (Head Global Quality Medicine at Boehringer Ingelheim) opened the presentation sharing an inspiring invitation to innovate in the Quality domain. Kiernan Trevett (Quality Policy Chapter Lead, Roche and IMPALA CAR WPT leader), Paula Walker (Global Head of RBQM, Roche) and Roshan D’Souza (Head of Quality Excellence Digital, Roche and IMPALA Steering Committee Chair) provided a holistic, end-to-end view of the CAR methodology including  the value proposition, efforts to date and engagements with regulatory agencies and their feedback. The presentation was well received with great interest and engagement via Q&As facilitated by Jennifer Emerson (Head of Quality Analytics and Risk Management, Boehringer Ingelheim and IMPALA Steering Committee Co-Chair). Thanks again to Boehringer-Ingelheim for inviting us to present.  

 

The Value of In-Person Collaboration  

Beyond the tangible deliverables, the intangible benefits of meeting face-to-face were immense. Being in the same room allowed the team to openly discuss in an inclusive and safe space, the real barriers to adoption and align swiftly on strategies to overcome them. This environment galvanized the work product team, building incredible momentum and shared ownership for the delivery and implementation of this initiative. 

 

The Roadmap Ahead  

Capitalizing on this momentum, we have developed a milestone-based plan to complete all CAR deliverables and established the timeframes needed to reach our end state. We are actively driving toward delivering a comprehensive implementation package by Q3 of this year. To support this rollout, we also discussed a communication plan detailing our next steps for taking this externally to Consortium Members, the wider Industry, and Health Authorities. 

Thank you for your continued support as we work to transform quality oversight in clinical trials. A special thanks to Boehringer-Ingelheim, a founding member of the IMPALA Consortium, for hosting this IMPALA workshop and for their hospitality.