July 24, 2023
Advancing Cell and Gene Therapy
Advancing Cell and Gene Therapy: A Case Study on Rapid CSR Development Challenges: A pioneering West Coast US Biotech urgently needed to write the CSR and SAE narratives for their Phase 1 cell and gene therapy clinical trial. The client had a tight deadline to submit the CSR to the FDA within a few weeks.…
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Morula Health
October 19, 2022
IND to IMPD Adaptation to Open Sites in Europe and Israel
Morula Health’s expertise and quick solution allowed for easy adaptation of an IND to IMPD for one of our clients. 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…
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