The clinical study report under the microscope

Nowhere in the pharmaceutical industry is the relationship between cost, price and value better demonstrated than in the delivery of the clinical study report (CSR). Delivery of the CSR is often viewed simply as dotting i’s and crossing t’s at the end of the clinical trial process. And yet, once the study participants have been thanked, the samples analysed and the many study documents archived, the CSR is the one single aspect of the study that remains visible for the lifetime of the product. Will it reflect the care you put into conducting the study? Will it clearly represent the study’s findings and communicate the true value of your investigational medicinal product (IMP)? Considering these challenges, you need to consider carefully who should write your study report.

To ensure prompt delivery of high quality CSRs, the author needs to both understand regulatory requirements and have the ability to decode the many aspects of the project knowledgebase. If you write the CSR yourself (assuming you have the know-how), you will avoid the cost of finding, employing and instructing a third party; however, the minimum price you pay will be loss of your valuable time. Your other responsibilities – such as programme management, site negotiations and addressing IMP issues – may affect your focus, preventing you from concentrating on the next task in hand. And are you aware of the most recent regulatory requirements – for example, do you know enough about Policy 0070 to address its challenge when writing the report? You could hand the work to a colleague but the challenges remain the same.

At Niche we care about the quality of CSRs within the industry and have written over 600 CSRs in the last 18 years. Now you can share some of the insights we have gained from all that experience. Please download our introductory guide and resource (here) and avoid making the most obvious mistakes. Don't forget to sign up to receive future issues of Insider's Insights and use any of the other resources we provide freely on the Niche website. We also welcome topic suggestions for future issues of the Insider's Insights.

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