• A full root-cause investigation and impact assessment of an inadvertent incident of un-blinding of investigators and project staff on a pivotal phase 3 IND study.
• A vendor selection assignment for a phase 1 radio-active micro-dosing study.
• At the request of a global Pharma company, an evaluation of key European investigator sites prior to the award of a complex phase III development program.
• A program of system audits for a Japanese pharma company that resulted in significant process re-engineering and business optimisation.
• A series of system audits of a global Pharma company’s European affiliate offices as part of its corporate governance program.
• The conduct of 120 clinical investigator site audits in over 45 countries within the last 5 years.
• The conduct of a series of medical device investigator site audits in France and Germany.
• Within the last two years, for-cause investigations covering the recruitment of ineligible subjects, the use of subject samples outside of the approved study protocol and falsified clinical assessments have been conducted.
• Amongst an array of other inspection-related assignments, the completion of a full mock GCP inspection (including the company offices and investigator sites) and MAA submission review for a virtual European biotech company and the subsequent support of them through inspection by the EMA which lead to the CHMP approval of the Western World’s first gene therapy product.
• Wider Perspectives was commissioned to act as an expert GCP witness for a case brought at the High Court in the UK.
• The conduct of a GCP due diligence assessment of an Indian Pharma company for a US/European biotech organization looking for a co-development partner. The assessment identified a series of risks which enabled this customer to proceed in an alternative direction.
Process and systems
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