The US-based CRO Symbio is looking for alliances with Indian CROs. The company has just begun to scout for partners in India. Symbio, with its primary strengths in the generics front is currently involved in studies relating to skin care, face care, women health including oncology, Nurjehan Jivani, associate director, Scientific Affairs, Symbio told Pharmabiz.
Symbio identifies and manages the appropriate sites and patient populations for studies. It also plans, manages, monitors and reports clinical study results from protocol development through final report for few to many centres in full compliance with all FDA regulations and ICH guidelines. The company carries out monitoring and project management of phase I through phase IV clinical trials to support safety and efficacy studies for INDs and NDAs, and clinical equivalence trials for ANDAs.
The company is talking to several Indian pharma companies that are looking at conducting clinical trials in the US that meet FDA regulations. At the same time it is also on the look out for suitable clinical sites in India which can be involved in the multi-centric trials being conducted by the US companies, particularly in the area of anti-malarial drugs, she informed.
India is proving its strengths in the field of bio-equivalence studies and the world is looking at partnering with the country for several positive reasons. There is a growth in overall pharma and CRO industries in India following growing thrust on R&D, increase in overseas acquisitions by Indian companies and strengthening India's image in IP creation and protection.
Indian CROs should adhere to standard operation procedures and timelines. US pharma companies are keen to tie with Indian CROs for the prime reason that the patient recruitment can be easy and quick. If the Indan CROs fail to utilise this advantage of facilitating quicker trials, overseas companies will not show interest to approach them, as some Indian CROs are proving as expensive as their counterparts in the US. Time to market is proving critical for pharma companies, she pointed.