Beat Widler, PhD
Managing Partner and Co-Founder

25 years with Roche in Switzerland in the areas of regulatory affairs, clinical research and Quality Assurance & Risk Management;
5 years Head of Pharma Development UK, Welwyn Garden City, providing leadership to 750+ drug development professionals.

Quality Risk Management & Quality by Design (QbD)
Process analysis and re-engineering in:
- Clinical Trial Management and Monitoring
- Pharmacogivilance
GCP Issue Management
SOP Development & Management
Regulatory Intelligence for Compliance

Quality Risk Management in Clinical Trials and Drug Safety - strategy, concept, methodology, process and organizational design and implementation
Built the Roche CQA department into a fully integrated Quality Management function providing quality risk management and QA oversight to the areas of Pharma clinical trials (phases (1-4) and Pharmacovigilance including CSV and vendor quality management aspects
Development of an SOP management system for a global software company
Leader of Task Force for QA- & GCP-- integration of Roche Japan development operations
Coordination and organization of FDA, EMA initiated inspections globally
Lead the Roche Clinical Trials Posting and Transparency Inititiative. A team of Roche IT and medical writers with the support of CenterWatch and Boston Consulting Group building a web-based registry of Roche clinical trials and a database of trials' results
Developed and implemented the strategy for the off-shoring of all transactional Disclosure activities to a third-party service provider
Provided leadership to the Roche Ethics and Sustainability work groups.
Conducted more than 100 audits worldwide (e.g. Europe, Eastern Europe, US, Latin-America, Japan, Australia and China
Member of the Board of DIA and member of the strategy committee of EMPRA, an EU Commission project.