Morula Health’s expert team of writers and flexible approach help Chinese biotech prepare for IND submission
Background
A Chinese biotech focused on infectious diseases needed a flexible, long-term medical writing partner to help with documents for submission to the FDA ahead of their upcoming IND. They had in-house medical writing capabilities however this was mainly focused on developing documents for their trials based in China and APAC. As they prepared for their IND submission, they needed support from English-speaking medical writers with a range of expertise and infectious disease experience to help with various clinical and regulatory documents.
Challenges
As this was one of their first programs to seek IND approval in the US, there was a lack of experience interacting with the FDA and developing documents that adhere to FDA guidelines. The level and type of medical writing and QC support were predicted to vary throughout 2023, so it was likely that multiple medical writers would need to be assigned throughout the partnership. To ensure their documents had the required degree of readability and accuracy, they required medical writers who were fluent in English and could communicate the scientific data and key messages.
Solution
Flexible and scalable
To provide the flexible and scalable solution our client required, we implemented a Functional Service Provider (FSP) contract, which included a pre-determined maximum number of hours and an agreed hourly rate that was consistent throughout the whole partnership. The FSP arrangement covered all deliverables related to medical writing, QC, translation review, and project management. It enabled us to be flexible and react quickly to their requirements.
Quick project start-up
The flexibility of the FSP agreement also facilitated quick project start-up times and writers with infectious disease experience were available at short notice which ensured they avoided costly delays to projects. Our global team of medical writers, and the project management team, worked to align with Chinese working hours so they could attend meetings and provide strategic input. Our project management team provided frequent and transparent reports on project progress and budgets which allowed our client to see where hours were being used.
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