PRA Health Sciences supported 2 multiple myeloma clinical trials, a Phase III and a “rollover,” for a large biotech client. This management contract was one of the largest on record in the ongoing research for multiple myeloma treatment. PRA’s clinical team provided enhanced communication and site support, enabling PRA to streamline regulatory document collection to quickly activate sites. Approved by the FDA after a 4-month accelerated approval process, the drug is the first in a new class of anti-cancer agents called proteasome inhibitors.
Optimize drug therapy with respect to the patient’s genotype, ensuring maximum drug efficiency with minimal adverse effects.
Literature Surveillance: Important Information About Patient Safety
Pharmaceutical companies must screen and analyze published literature from the clinical development stage through post-marketing as part of their…
Patient Safety and Pharmacovigilance Agreements
Pharmacovigilance Agreements (PVAs) are agreements between two companies based on their Commercial Agreements that require an exchange of safety…