This case study considers the production of an ISS and ISE for an orphan drug.
Quanticate supported a virtual biopharmaceutical company across the full remit of clinical data services for the development of a new biosimilar.
Quanticate has successfully worked on a Hemophilia clinical trial where biostatistical and programming support via an FSP model were delivered.
One of the most powerful aspects for ensuring a successful relationship, and a key part of the FSP model, is the governance between the sponsor and CRO
This case study presents a long-term Functional Service Provision with one of the top five pharmaceutical company across our biostatistics and clinical programming services.
Quanticate has been working successfully with a large Scandinavian pharmaceutical company over the past 12 months in the area of clinical data management (CDM) and is focused on the delivery of clean quality clinical trial databases.