A Top-5 global pharmaceutical company selected Kinapse as one of three CROs to be preferred providers to manage, author and QC Clinical Study Reports (CSRs), Safety Narratives, Basic Results (BRs) and Website Synopses.
The objective was to provide high quality documents using company templates and adhering to company SOPs and guidance.
A blended onshore-offshore team was established for each worksteam.
After 6 months, the BR workstream was moved purely offshore.
Onshore medical writers provided oversight of quality ensuring ICH and templates were adhered to.
Dedicated offshore team of writers, with flexible size, enabled large volume of documents to be generated.
After 1 year:
The engagement is ongoing