A startup company developing a new drug to treat blood cancer lacked the expertise to draw up the required documentation. XPE Pharma & Science helped put them on track.
Following initial research and development, the client wanted to launch a Phase I clinical study, which involved a large amount of documentation. However, being a startup, they had little expertise of their own in this matter.
XPE provided the client with an experienced medical writer who advised them on the various documents they needed. Additionally, he created indispensable templates and used them to write the first reports together with client-employed clinical trial experts.
With the support of XPE’s expert writer, the client was able to identify the requirements, roll out a document development process, and submit the necessary clinical trial support documents to the authorities, in the right format, thereby guaranteeing a timely initiation of the study.