Swiss contract organisation (CRO) PFC Pharma Focus has further internationalised its business by partnering with Excel Life Sciences (ELS), a US-based trial management association focused on the Indian market, to launch PFC India, a full-service CRO specialising in clinical monitoring and data management services.

Based in New Dehli, PFC India is a division of PFC and a distinct entity from ELS that will service the clinical trial support needs of biopharmaceutical companies and CROs in India, offering study planning, monitoring, audit and data management capabilities.

According to Dr Vijai Kumar, president and chief medical officer of ELS, PFC India “will bring an unprecedented focus on quality data and good clinical practice to India, at a time when the FDA and Drugs Controller General’s office of India [are] stepping up [their] compliance standards and pharmaceutical companies are requesting a high level of service, preferably from an experienced and established brand”.

The number of new clinical trials started in India is growing at a rate of more than 50% a year, the new partners noted. Dr Kurt Pfister, co-founder and chief executive officer of PFC Pharma Focus, said the initiative would give the Swiss CRO’s clients access to a large and diverse patient population as well as a significant number of patients with rare diseases.

ELS “is well established in India and the team has market-leading experience in conducting global trials”, Pfister added. “They have a proven track record in involving high-performing centres with very good patient recruitment and retention rates and will enable us to make a smooth entry into this geographical area.”

In January, PFC Pharma Focus signed a partnership agreement with Blanchard y Asociados, a clinical research consulting firm based in Buenos Aires, Argentina, to provide clinical and project management services in South America.

Founded in 1992, the CRO has been gradually widening its global reach, setting up PFC Pharma Focus GmbH in Munich, Germany in 1999; striking an alliance with PharmaResearch Corporation for the US and the UK in 1999; tying up with SocraTec R&D in Germany in 2002; establishing partnerships or regional offices in Romania, Bulgaria and India during 2005; and expanding into Israel in 2006 with the formation of Pharma Focus Ltd in Tel Aviv.

ELS has its headquarters in Chicago, Illinois, as well as US offices in Boston, Raleigh-Durham and Washington DC, plus further offices in Hyderabad, Mumbai, New Delhi and 21 other locations across India.

The company fields “one of the most experienced and respected clinical operations teams in India, with over 125 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients”, it says.