Genelife Clinical Research Provides Regulatory, project management, site management and monitoring services related to BA/BE studies. We at Genelife Clinical Research, help our client to chose best CRO as per their regulatory needs. We have a close association with the BA/BE CROs of India, Singapore, Middle East countries. We worked with some of the leading European CROs.
We assure our esteemed clients for protocol compliance and adherence to regulatory & ethical compliance through proper site startup, monitoring and closeout activity. Site startup activity starts with selection of BA/BE CRO as per the clients requirements related to budget and regulatory needs. It ends with the site Initiation.
We do perform in-process monitoring of study related activities which is in compliance with protocol and global ethical guidelines. We also ensure error free reporting, proper documentation of study procedure and capture deviation and events.
We also performed retrospective monitoring and audit of BA/BE studies.