Clinigene International, the CRO arm of Bangalore-based Biocon, opened a Human Pharmacology Unit HPU at the Sagar Apollo hospital. The unit claims to be equipped to handle cost-effective Phase I clinical trials and bio-availability (BA) and bio-equivalence (BE) studies on healthy human volunteers. The company has also set up a Bio-Analytical Unit at Biocon centre, which will analyze the blood sampling for the trials.
The HPU along with the Bio-Analytical Unit has been set up at a cost of Rs.6 crore out of which Rs.3 crore is only for the equipment, the company sources claimed. The HPU is spread over 3,000 sq. ft. and can accommodate 26 volunteers at a time. Within the HPU there is a volunteer housing, screening, counseling, blood sampling and an intensive care unit to handle emergencies, supported by a team of medical and research staff from Clinigene and Sagar Apollo Hospital.
According to Dr Arvind Atignal, chief operating officer, Clinigene, the facility will abide by global ethical and regulatory standards and adopt E-reporting format where web-based format will be maintained for the clinical and laboratory reports apart from having a tele-conferencing facility. The HPU can have the advantage of Clinigene's central laboratory, which is the first clinical diagnostic laboratory in the country to be accredited by the College of American Pathologist (CAP). Clingene would also train the staff of Sagar Apollo in good clinical practices (GCP), he added.