US-based Sephmer Sciences which is known for clinical trial development, outsourcing support and capacity building has acquired rights to operate in various states in India including Bangalore, Mysore, Pune, Mumbai and Chennai. The company commenced operations in India through a partnership with Bangalore Healthcare Development Pvt. Ltd. It will provide end-to-end solutions in clinical trials, besides assisting investigators and institutional review boards (IRBs) in the country.

The company has offices in New Jersey and Maryland in the US. Its focuses on clinical research solutions for all healthcare delivery services including hospitals, private nursing homes, laboratories, pharma-biotech companies and contract research organizations (CROs).

Indian entry was planned going by the country's potential to emerge as the clinical research hub. "We wanted to provide infrastructure and clinical research capacity support for both the global and national CROs that needed the trained workforce and expertise. Of course the primary aim of our operations is capacity building and clinical research infrastructure development at the hospital and healthcare institution level. We will work with physicians to form a three-member research teams (Principal Investigator, Study Coordinator, and Research Nurse), Lisa Castro, President & CEO, Sephmer Sciences International Corp told Pharmabiz.

Other key initiatives in India are to provide multiple services including modified site management organization (SMO), patient recruitment organization (PMO), and Investigator Development Organization (IDO) to help the CROs improve their operational efficiency, stated Castro.

Some of the solutions from Sephmer are SephmerAssist, Hospital Clinical Research Infrastructure Development and Research Team Establishment and Training. The products will help Indian companies to be linked to small, mid-size, and large biotech-pharmaceutical companies and ICH GCP-trained investigators in the USA.

Every project team has a US-based contact functioning as a liaison arm with the service delivery team in India. The installation of Citrix an application delivery platforms for SephmerTrials and TrialsVisit besides utilization of Oracle Clinical data management software will support the research initiatives.

The staff strength of the Sephemer India operations will be around 50 clinical research and information technology (IT) professionals to support the clinical trials needs of Indian and multinational companies.

Recently, the company had partnered with Clinical Research Consortium Pvt. Ltd. to provide a three-day training programme for 30 healthcare professional (including 20 physicians/doctors and dentists, and 10 nurses/research nurses) at the KLE College Belgaum in Karnataka.

According to Castro, the regulatory and business landscape is changing globally and in India. Pharmaceutical and biotechnology companies are looking to conduct a more clinical studies. There is an exponential increase in the number of trials conducted in India, China, Central/Eastern Europe Europe, South Africa/Africa, Asia Pacific, Latin America and Russia because naïve patient recruitment opportunities are huge in these regions.