View Adapting to process change

Adapting to process change

We provide case processing support to a global pharmaceutical company. In 2015, our client moved their global safety database to a new system. Our team adapted quickly to the new system, to deliver high quality, efficient case processing throughout the initial transition period and beyond. Challenges Creating effective, clear new case processing conventions. A short timeframe to adapt…

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View Ensuring compliance with rapid, accurate reporting

Ensuring compliance with rapid, accurate reporting

We are responsible for the submission of EU regulatory case reports for a global clinical trial, with a co-running trial using the same Investigational Medicinal Product (IMP), managed by another sponsor. In 2015, we received an extremely late case report from our client’s Pharmacovigilance (PV) team. Prior to this compliance and reporting had worked well….

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View Managing a named patient programme

Managing a named patient programme

In 2013, a client with a Named Patient Programme (NPP) designed to treat patients with an unmet ‘special’ clinical need following the end of a Phase I/II trial of their oncology product approached us to manage the programme. We have successfully managed the NPP with significant improvements and substantially refined procedures implemented. The project A…

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View Experts in the field

Experts in the field

Managing pharmacovigilance, medical information and quality complaints We manage pharmacovigilance (PV), medical information and product quality issues in the EU for a post marketed, global product. Our PV and Medical Information teams have developed expert knowledge of the product to provide a high quality, holistic service on behalf of our USA-based client. Our service We…

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