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Background
With more than 100,000 employees in 100 countries, our client is a pharmaceutical company based in France and active in many therapeutic areas including oncology and infectious diseases. Their medicines treat 28 million people each year.
Challenge
With the aim to start promptly a retrospective, secondary data use study in oncology, our client entrusted our medical writing team with the development of the clinical study protocol. The study design (including its population and endpoints) was strongly related to the results of an ongoing feasibility study. The challenges were to adapt the study design throughout the process of writing the protocol and to finalize the document within a tight timeframe.
Approach
The development process of the study protocol included two drafts and a final version. Each version was written and reviewed by a lead medical writer according to the sponsor’s recommendations and to the feasibility results, in compliance with best practices and applicable regulations and with the support of one of our biostatisticians. A second medical writer performed a full quality control of each version of the protocol (including data sources, format, style, and consistency).
Key results
Benefits
The extensive experience, the flexibility and the proactivity of our medical writing team allowed us to deliver the required document with the highest quality within the agreed timeline, in an efficient and reliable manner.
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