Theorem Clinical Research, a leading midsized provider of comprehensive clinical research and development services, and Excel Life Sciences (ELS), a US-based, India-focused provider of comprehensive clinical trial management services, have formed a strategic relationship to bolster Theorem’s clinical development offerings in India, including local site management expertise.
Excel Life Sciences has long-standing relationships with more than 1,000 hospitals and research centers across 25 cities throughout India, covering a broad range of therapeutic disciplines.
“ELS complements our own strategic offerings in the region and around the globe and extends our clinical trial capabilities,” said Marc Hoffman, M.D., Theorem senior vice president and general manager of biopharmaceutical development. “Collaborating together we can offer sponsor companies access to a wealth of high-quality research centers in India, a well- established research team with a strong understanding of ICH-GCP and, most importantly, the local knowledge for successful conduct of studies in country. There are obvious benefits for all: for sponsors, more robust patient recruitment and retention and, for patients, access to cutting- edge therapies and research programmes.”
ELS has developed one of the largest networks of investigators and investigative sites within India.
“Site management services from Excel Life Sciences help take the burden off investigators so they can focus on patient care and ensure that the study is conducted to the highest standards for quality, ethics and performance,” said Vijai Kumar, M.D., president and chief medical officer of ELS. “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. Operationally, our site management focus has translated into India patient enrollment and retention numbers that are significantly higher than comparative global performance for the same study.”