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XPE creates a medical writing program for a leading pharma company

A leading global pharmaceutical company with a substantial product portfolio sought help from XPE Pharma & Science to develop, update and archive a large body of documents relating to clinical trials.

Challenge

The company in question is continually running medical trails, both for existing and newly developed products. Global stakeholders are involved in this ongoing process, which entails an enormous amount of (legalistic) paperwork. The company needed an outsourcing partner to develop and archive all the documents cataloguing their clinical trials in line with strict regulatory requirements.

Solution

Together with the client, XPE selected a team of experienced writers and set up a training program to ensure every single one of them would be fully qualified to support the company at all times. This high-profile team quickly acquired the necessary knowledge to independently develop the required documents, such as study reports, protocols, Informed Consent Forms and Case Report Forms.

Results

At present, XPE provides the client with a fully outsourced team of ten scientific writers. They focus on the timely delivery of study-supporting documents, written in line with the ethical guidelines. In addition, they carefully archive a variety of study-related materials. A quality assurance team makes sure all the regulatory requirements are met. Thanks to this kind of on-site support, the company’s documents are delivered on time, allowing the client to focus on his clinical operations.