Outsourcing studies to India has become a time and cost effective and regulatory compliant method to evaluate new potentially equivalent generic forms of patented products that are about to expire. US and European-based companies frequently have limited experience with Indian-based clinics that provide such services.

Further, there is a healthy fear related to GCP compliance to any previously unknown facility. We have audited and monitored many such studies in India for our clients in the past. These services include an audit of the clinic's SOPs and equipment, monitoring of the conduct of the BE or BA clinical study per protocol, developing of the guideline compliant protocol, audit of the bioanalytical laboratory that is assaying the samples, audit of the clinical laboratory, ensuring that the retention samples are being held according to regulations, a complete audit of the foreign IRB/EC and the consent form that results from their review of the protocol. We conduct site qualification visits to multiple Indian-based clinical sites to ensure that they can conduct the study to GCP or ICH standards and to aid our sponsors in site selection. We then can place the study with the minimal lead time, audit and monitor the conduct of the study and review the report that is submitted at completion of the work. Our clients save time and money by using these outsourcing services.