The Orphan Reach Pharmacovigilance department routinely undertake all contracted activities required for the management of safety information from clinical trials and has a proven track record across multiple therapeutic areas and phases (I-IV).
We appreciate the critical importance of ensuring that an effective pharmacovigilance system is in place for all clinical studies. Our expertise guarantees that serious adverse event information and all other safety information is collected and reported to the appropriate individuals and organisations within the required timelines on all studies we work on.
The flexibility of our Pharmacovigilance offering means that we can tailor our solutions to our individual client’s needs across the entire pharmacovigilance process:
– Set up of PV specific processes and procedures
– Set up dedicated efax number
– Evaluation of safety data
– Management of serious adverse event data
– MedDRA coding
– Unblinding
– SAE narrative writing
– CRF review
– SAE reconciliation
– 24 hour safety “on call” services
– Electronic reporting of SUSARS to Eudravigilance Clinical trial module via EVWeb
– Reporting of paper copies SUSARS to CA/CEC/Investigative sites
– Preparation and submission of six monthly line listing to CEC
– Preparation and submission of Annual Safety Report to CA/CEC/Investigative sites
– PV Consultancy/Advice
– PV Training
We understand that drug safety, risk management and maintaining regulatory compliance are of primary consideration.