Background
The client, a US Biotechnology company, was running clinical trials in the US. With these existing trials going well, they wanted to expand their research program. They required a written Investigational Medicinal Product Dossier (IMPD) within two weeks to adhere to their investors’ ambitious site initiation timelines. An Investigational New Drug (IND) was already in place, with all the required data readily available and completed to a high standard.
Challenge
The funding was in place for boosting recruitment and opening sites in Europe, but they didn’t have the resources or knowledge to operate in line with European regulations. All their existing documentation was written to follow US guidelines, and they needed help to adapt to a new location and expand their research quickly and efficiently.
It was important to adhere to the short timelines as failure to do so could cause a delay in opening clinical trial sites and access to the drug for patients.
Solutions & Results
Rapid solution
With our team of experienced writers, Morula Health was able to offer a rapid solution. We assigned a Medical Writer in the UK, who is also a QP with extensive experience writing Common Technical Document (CTD) Module 3 and IMPDs. Using our secure file-sharing system, the source documents were uploaded and readily accessed and reviewed by the Medical Writer.
Utilize time efficiently
Within one week our writer began work, adapting the IND to IMPD. Despite being in different time zones, the geographical advantage allowed us to utilise time more efficiently. Our Medical Writer could send their questions at the end of their day, and the US-based client could respond on the same day. This streamlined process ensured that the Medical Writer could begin their next working day with the answers in their inbox. The IMPD was finalised within two weeks, needing just one round of review. With these documents in place, the client’s chosen CRO could move forward in seeking regulatory submission and contacting sites. Due to Morula Health’s innovative solution, the research program was in an excellent position to expand.
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Our work
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