XPE Pharma & Science launched a full Phase I clinical study for a start-up that lacked the necessary expertise to complete the required administrative and legal steps.
The client, a Belgium-based startup that invented a drug to treat blood cancer, was eager to move forward after the initial research and development phase. Their aim? Launch a Phase I clinical trial. Yet, being a startup, they didn’t have the internal expertise required to develop the necessary documents. So they went looking for that experience elsewhere – enter XPE.
XPE provided the client with an experienced medical writer, who talked the entire process through with them and consulted them on the documents they needed. This expert then got to work on template materials that proved indispensable throughout the Phase I clinical study. Together with client-employed clinical trial experts, the XPE expert also wrote the first reports.
Thanks to the support of this expert writer, the client met the requirements, started a document development process, and successfully submitted the necessary clinical trial support documents to the authorities. This ensured a timely initiation of the study.