Biotech, pharma, and medical device companies are all striving to expedite non-clinical and clinical studies while maintaining the stringent standards necessary for marketing approval. Historically, many companies have relied on outsourcing to clinical research organizations (CROs), on a full-service basis, as their primary strategy for conducting clinical studies. But now, this industry is beginning to see a shift to functional service providers (FSPs) to conduct their scientific and medical writing. This includes the creation of clinical and regulatory documents required for the submission of an Investigational New Drug (IND) or Clinical Trial Application (CTA).
A CRO’s primary focus lies in conducting clinical studies, and their admirable competency in this domain is worthy of acknowledgment. Their substantial contributions to the life science industry in the past two decades have been remarkable. However, while managing and executing complex global clinical studies involving thousands of participants across multiple countries, medical writing is sometimes regarded as an ancillary aspect rather than a central focus.
The industry is experiencing significant growth in medical writing specialist service providers, which become embedded within an organization. They standardize clinical, nonclinical, Chemistry, Manufacturing and Controls (CMC), and regulatory documents across the whole organization including all ongoing programs and therapeutic areas. This approach stands in contrast to the traditional siloed structure, where each study team and project team operates separately within their respective CRO.
We deliver medical writing solutions, tailored to you and your needs. For example, we provide writers with extensive experience writing complex documents, deep therapeutic experience, and knowledge of working with other similar companies to you.
Frequently during the development process, various documents require the use of the same underlying data and source documents. For instance, the Investigator’s Brochure (IB) and Investigational Medicinal Product Dossier (IMPD). A single specialized partner ensures consistency through efficient management of your up-to-date source documents. Additionally, you can benefit from a reliable, experienced, and consistent team of medical writers.
Morula Health are a trusted global partner in medical writing for pharmaceutical, biotech, and medical device companies.
Our track record speaks for itself:
