Theorum Partners With Excel For Indian Clinical Site Management

Theorem Clinical Research announced in a press release that it has formed a partnership with Excel Life Sciences, an Indian contract research organization (CRO). The collaboration will improve Theorem’s presence in India, in particular strengthening its clinical trials and site management.

Theorem and Excel Partnership

The agreement between Theorem and Excel offers Theorum the opportunity to access Excel’s network of 1,000 Indian hospitals and research centers in 25 cities. The two will offer clients research teams, local knowledge, and patient recruitment and retention services. Vijai Kumar, M.D., president and CMO of Excel, said that his company takes the burden from investigators so they can focus on patient care and research quality. He added, “This support ensures collection of high-quality study data necessary for the U.S. Food and Drug Administration, the European Medicines Agency, and other global regulatory and product approval agencies.”

India Strategy

Due to India’s status as one of the most highly populated countries with millions of treatment-naïve patients, the market opportunity is attractive to pharmaceutical companies. However, the clinical environment has been challenging, especially in the last few years as the Government has instituted new rules. Recently, the Finance Minister announced that the tax exemption for clinical research will be withdrawn, subject to Parliament’s approval. The change will cause a 12 percent increase in clinical costs.

Theorem’s Dr. Pottoff offered insights into improving the Indian clinical trial environment. He said that companies would do well to think through their recruitment and retention strategies and to use incentives that would best appeal to targeted patients. He said that local CROs provide the intelligence needed to reach the people required for the particular study. He said, “One is to strive to work with as local of an understanding as possible. Having a physical presence in the places you’re doing research helps you better understand regulatory and cultural climates, as well as what patient recruitment methodologies work.”

Dr. Kumar at Excel acknowledges the challenges in India, but remains optimistic. He said that the regulatory approval timeline in India is about five months, similar to other countries. He offers companies a tip, saying that getting the submission right the first time will significantly improve approval times.