A new article published in Applied Clinical Trials Magazine addresses and challenges some of the most common myths related to the conduct of business and clinical research in India. The article, titled "Demystifying India -Understanding common myths and truths surrounding one of the fastest growing clinical trial markets" provides readers with a unique perspective on the unique realities of daily life in India which impact clinical research in different ways. Topics/myths covered include a discussion on the the stability of the market, the complexity and timeliness of the regulatory environment, the structure and operating process of IRBs, the informed consent process and the enrollment of patients in India. Below is a small excerpt from the article. Please click on the link to proceed to the Applied Clinical Trials Online website to read the full article:
Excerpt from "Demystifying India -Understanding common myths and truths surrounding one of the fastest growing clinical trial markets" published July 31, 2009, author: Dan McDonald - VP, Business Strategy, Excel Life Sciences:
"But India can be as confusing and slow as much as it seems simple and efficient. It can be scary and overwhelming as much as it is warm and traditional. India can mean faster, lower-cost clinical trials, but it can also mean 85 people sitting in the waiting room of a small eye clinic at 9:00pm hoping to get a visit with a doctor before he leaves at 10:00pm after putting in a 14 hour day. Most will have to go home and try again tomorrow—even though home may be two hours away."
Click here to read the full article.
European CRO and US-based Trial Management Organization Announce Unique Partnership to Ensure Highest Quality of Clinical Trials in India. New Venture to Provide Sponsors Access to Global Experience, Diverse Patient Population, Highly Trained Investigators and Local Expertise.
Zürich/Chicago (PRWEB) 18, June, 2009 – In response to growing demand by European and US biopharmaceutical companies for clinical trial support services in India from established and proven providers, Excel Life Sciences (ELS), a US-based India-focused clinical trial management organization and PFC Pharma Focus (PFC), a Switzerland-based pan-European contract research provider, announce the launch of PFC India, a full-service contract research organization specializing in clinical monitoring and data management services.
The exclusive relationship between ELS and PFC to launch PFC India combines the strengths of a long standing and successful European CRO with the local expertise, ground-based business savvy and quality focused trial management of ELS.
PFC India is established as a division of PFC and is a distinct entity from ELS and will service biopharmaceutical companies and CROs with their clinical trial support needs in India. The office will be located in New Delhi. Specifically, PFC India will offer its clients study planning, monitoring, audit and data management services.
“I am very pleased that we can extend our clinical research services with PFC India from Europe to Israel to India and to offer our clients access to a large diverse patient population as well as to a significant number of patients suffering from rare diseases" said Dr. Kurt Pfister, CEO and co-founder of PFC Pharma Focus Ltd. in Switzerland. India offers the unique opportunity of highly trained medically qualified persons and a legal and regulatory environment fully supporting international GCP standards. ELS is well established in India and the team has market leading experience in conducting global trials. They have a proven track record in involving high performing centers with very good patient recruitment and retention rates and will enable us to make a smooth entry into this geographical area. “Selection of ELS as a partner was a result of rigorous due diligence and a shared vision to conduct clinical research with the highest levels of credibility, ethics and integrity” said Dr. Pfister.
“We are excited about this new relationship, brining one of the most respected European-based CROs to India. 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 is stepping up it’s compliance standards and pharmaceutical companies are requesting a high level of service, preferably from an experienced and established brand” said Dr. Vijai Kumar, President and Chief Medical Officer of Excel Life Sciences.
The number of new clinical trials initiated in India is currently growing at more than 50% annually, a growth rate that is requiring a substantial amount of participation from India’s strong physician base and medical institutions in the form of new clinical investigators and research sites. In addition, the number of patients participating in trials in India is growing as well. Combined, these market changes make it essential that all studies are monitored and managed at or above the highest international standards to ensure quality, timeliness and safety.
About Pharma Focus
Based in Switzerland, PFC Pharma Focus is a premium contract research organization (CRO), providing product development services in the life science and health care industries. Founded in 1992 by prominent experts in all realms of clinical services, the mission of PFC Pharma Focus is to bring a new look to the drug development experience by addressing the limitations of conventional study practices. This year marks PFC 17 anniversary providing clinical services, and our clients and partners include pharmaceutical, biotechnology, medical device, and academic and government organizations. PFC services include running clinical studies from phase I to IV+, medical writing, importing through storage to distribution of clinical material, training in pharmaceutical medicine and development of risk management plans. For more information visit: http://www.pfc-cro.com/pages/index.cfm
About Excel Life Sciences
Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, Washington DC, Hyderabad, Mumbai, New Delhi and 21 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.
ELS has 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. ELS has also trained over 1,500 clinical research personnel in India. For more information visit: www.excellifesciences.com
Contact:
Excel Life Sciences
Chicago, IL
Phone: 773 251 2976
Contact: Kurt Pfister
PFC Pharma Focus Ltd.
Zürich, Switzerland
Phone : +41 44 908 66 66
Fairfield, CT - (January 12, 2009) - Competitive Technologies, Inc. (NYSE Alternext US: CTT) announced today that it has received a sales order from Excel Life Sciences, Inc. (ELS) for pain management therapy devices. The device is a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs. ELS, CTT's country-exclusive distributor in India, recognizing the benefits of the innovative device, was the first announced healthcare services provider to sign a distribution agreement for the device. Subsequent distribution agreements granted country-exclusive distribution rights to GEOMC Co., Ltd. for Korea, to AG Healthcare for Malaysia, and to Biogene Pharma Limited for Bangladesh.
The order from ELS has an approximate retail value of up to $1 million. Shipment of the devices to ELS is scheduled to begin immediately.
ELS is a U.S.-based, India-focused provider of clinical research and healthcare services. They have a special focus on improving patient care in the markets in which they operate. ELS has a fully-owned Indian subsidiary with its main office in New Delhi, and 21 operational locations serving a network of over 700 hospitals across India.
The CTT device has Medical Device CE certification from the European Union allowing sales of the device throughout Europe and several other countries, including India. Approval of CTT's pending FDA 510(k) medical device application will authorize U.S. sales of the device. The review and selection process for distributors in Europe, Asia, the U.S. and Latin America is continuing. CTT has exclusive worldwide rights to this patented device.
Dr. Vijai Kumar, ELS's President and Chief Medical Officer, said, "We have seen this device in action, and have witnessed its pain relieving capabilities. ELS is starting formal clinical studies using this new pain management device at four leading healthcare facilities in India within the month. The protocol for these studies will follow U.S. FDA guidelines and treat a total of 160 patients divided into four specific neuropathies. We expect this new device to initiate a paradigm shift in the perception and treatment of pain in India. There are over four million people in the country suffering from severe cancer, neuropathic pain and other forms of chronic disabling pain."
Mohit Mehrotra, ELS's Founder and Chief Operating Officer, commented, "We are proud to work with CTT to bring this progressive medical technology to India. We are focusing considerable resources on this technology and our relationship with CTT. We will be launching the device at the All India Institute of Medical Sciences' (AIIMS) International Conference of Indian Association of Palliative Care in February, where we expect it to generate a high level of activity and interest among the participants. ELS is a sponsor of the New Delhi-based conference, the largest of its type. Our extensive knowledge about healthcare in India, along with a large network of research hospitals and clinics, helps us understand the needs and expectations of both patients and healthcare providers. We believe this device will revolutionize pain management for both constituents."
"ELS is a key element in our strategy for building a strong distribution base across the Indian continent through Southeast Asia," said Aris D. Despo, CTT's Executive VP, Business Development. "They are an effective and strategic partner for CTT in the important Indian market. India's $1.75 billion medical device market, supported by its growing middle and upper classes of over 150 million people, represents a significant opportunity for sales of our innovative pain management technology."
"We believe that revenue and profits from the pain management technology will dramatically exceed those produced by any other technology in our 40-year history and reach approximately $200 million per year in distributor sales to hospitals and clinics as the device attains mature market levels," said John B. Nano, CTT's Chairman, President and CEO. "We expect financial results generated by this medical device to have the potential to significantly increase CTT market capitalization. This medical device is a prime example of our strategy to connect clinical science to patient care, improving healthcare for mankind."
Developed in Italy by CTT's client, Prof. Giuseppe Marineo, the technology was brought to CTT through the efforts of Prof. Giancarlo Elia Valori of the Italian business development group, Sviluppo Lazio S.p.A., and assistance from the Zangani Investor Community™. The technology, with a biophysical rather than a biochemical approach, uses a multi-processor able to simultaneously treat multiple pain areas by applying surface electrodes to the skin. CTT partner, GEOMC Co., Ltd. of Korea, is manufacturing the device commercially for worldwide distribution. For more information on the device, visit www.CalmareTT.com.
The device has been used on over 3,000 patients in Europe, including at the Pain Management Center at Tor-Vergata University Medical Center in Rome (http://www.ptvonline.it/uo_ter_ant_ing.asp)., and at Fondazione Parco Biomedico San Raffaele in Rome (www.scienceparkrome.eu).
About Excel Life Sciences, Inc.
ELS is a U.S.-based, India-focused provider of comprehensive clinical research and healthcare services, helping to advance science and improve patient care. ELS is a privately owned Delaware corporation, with 21 operational locations across India and a network of approximately 1,000 physicians serving over 700 hospitals. ELS has U.S. offices in Boston, Chicago, and Durham, N.C. Its success is built around passionate and experienced individuals working alongside clients to accelerate clinical research and deliver new drugs and medical devices to the markets, while maintaining the highest standards of quality. ELS is committed to improving and expanding the clinical research enterprise in India. Visit ELS's website: www.ExcelLifeSciences.com
About Competitive Technologies
Competitive Technologies, established in 1968, is a full service technology transfer and licensing provider focused on the technology needs of its customers and transforming those requirements into commercially viable solutions. CTT is a global leader in identifying, developing and commercializing innovative technologies in life, electronic, nano, and physical sciences developed by universities, companies and inventors. CTT maximizes the value of intellectual assets for the benefit of its customers, clients and shareholders. Visit CTT's website: www.competitivetech.net
Statements made about our future expectations are forward-looking statements and subject to risks and uncertainties as described in our most recent Annual Report on Form 10-K for the year ended July 31, 2008, filed with the SEC on October 28, 2008, and other filings with the SEC, and are subject to change at any time. Our actual results could differ materially from these forward-looking statements. We undertake no obligation to update publicly any forward-looking statement.
