Excel Life Sciences expands services to meet Indian clinical trials opportunities

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Revised and conducive regulation in India is triggering growth of clinical trials. Excel Life Sciences (ELS) is expanding its regulatory, clinical trials, and medical writing services.

Excel Life Sciences expands clinical trials practice in response to progressive environment in India

Recently, Indian regulatory bodies have strengthened the guidelines and infrastructure requirements while clarifying compensation and patient safety regulations. [1]

This triggered increased clinical trials activities in 2015 and improved the regulatory approval timelines. Conforming to the industry expectations, ELS has been able to obtain regulatory approvals in India within approximately 3 months of applying.

In support of the growth Excel Life Sciences is expanding it's regulatory and clinical trials practice, while adding a third US office, in Boston Massachusetts.

With the growing pharmaceutical development and commercialization opportunities, clinical research is expected to grow by approximately 15% over the next year . Regulatory actions by the European Medicines Agency are also creating a need for conduct of higher quality clinical trials by Indian pharmaceutical companies. Recent court rulings in favor of Novartis, concerning ONBREZ® for chronic obstructive pulmonary disease, and Bristol Meyers Squibb for patent of dasatinib , a drug for chronic myeloid leukemia, also contribute. [2]

“The new government is increasing India’s visibility and importance in the global arena. We are experiencing a significant increase in the overall interest in the Indian market” says Mohit Mehrotra, ELS’ Chief Operating Officer.
Seventeen percent of the global population (1.25 billion people) reside in India forming a huge market for pharmaceutical and medical device companies. Patient care is also improving in the country with increased earning potential of the middle class and an increased focus on healthcare and its delivery. The market for innovator drugs is big as the upper class is now willing to pay for better quality care.

According to Dr. Vijai Kumar, Chief Medical Officer of ELS,“We have successfully navigated and implemented the recent regulatory changes including audio visual taping of patient informed consent. We believe that conducting trials with the highest levels of ethics and integrity are critical to growth of the industry in the next few years. Our clinical trials business is seeing increasing demand.”
1. Economic Times World Health, July 2015 / 2. Financial Express, Pharma Voice, July 2015

About Excel Life Sciences

Excel Life Sciences (ELS),India’s premier clinical trial and site management organization with extensive regulatory and clinical trials expertise, leads a network of ICH-GCP compliant investigators across 30 cities. ELS maintains a focus on North American, European and Asia-based clients for global studies via its offices in Boston, Chicago, New Delhi, and Research Triangle Park, NC. Its senior management team has played important roles as members of committees constituted by the Drugs Controller General of India to frame the Indian guidelines for Good Clinical Practice and make changes to globalize India’s clinical research enterprise. The team also plays important roles as members and Board of Governors of the Institute of Clinical Research, India (ICRI), as well as the Central Drugs Standard Control Organization, World Health Organization, and other industry associations.

For more information, please contact Donald Swankie, Vice President, Excel Life Sciences, at +1 919.889.6387 or donald(at)excellifesciences(dot)com

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DONALD SWANKIE
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