PFC Pharma Focus and Excel Life Sciences Announce Clinical Research Partnership in India

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: Mohit Mehrotra

Excel Life Sciences

Chicago, IL

Phone: 773 251 2976

Mohit@ExcelLifeSciences.com

www.ExcelLifeSciences.com

Contact: Kurt Pfister

PFC Pharma Focus Ltd.

Zürich, Switzerland

Phone : +41 44 908 66 66

Kurt.pfister@pfc-cro.com

www.pfc-cro.com

Excel Life Sciences and Investigator Support Services Announce Clinical Research Partnership

Dec. 18, 2008, Chicago, IL - Excel Life Sciences (ELS), a U.S.-based, India-focused provider of comprehensive trial management services announces that it has formed a partnership with Chicago-based Investigator Support Services (ISS) to help biopharmaceutcal companies and CROs identify investigative sites in India for their clinical research studies.

ELS has one of the largest networks of investigative sites in India with over 1,000 investigators and 700 sites. Each site has undergone an extensive due diligence visit and review by ELS to determine its experience and capabilities before they are accepted into the ELS network, enabling ELS to find the most qualified investigative sites for customers. In three recent studies, sponsors selected 100%, 80% and 100% of sites recommended by ELS for the study.

“We are very excited to be partnering with ISS to help their customers identify appropriate investigative sites in India. We are confident that together we can help more companies enter into India and run successful, on-time clinical studies,” said Dr. Vijai Kumar, President and Chief Medical Officer, Excel Life Sciences.

ISS represents 400 experienced sites with capabilities to conduct phase I-IV drug and device studies in all medical specialties.. All sites pass a quality review prior to inclusion in the ISS network and are further pre-qualified for individual studies based on protocol requirements. At no cost to industry sponsors and CROs, ISS quickly provides study related documents and contact information for the most appropriate investigators. Sponsors and CROs negotiate budgets and contracts with site personnel, make the final selection decision, and remit payment directly to participating sites.

“For 16 years, ISS has supported drug development in by matching clinical trials with qualified investigators. Each year we successfully place sites on nearly 250 studies for more than 80 sponsors and CROs in the United States, and we are excited to expand our reach to India in support of global clinical research,” said Sarah Ebner, President, Investigator Support Services.


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.


About Investigator Support Services
Investigator Support Services (ISS) supports industry sponsors and CROs, worldwide, by expediting site identification for phase I-IV studies across all therapeutic areas. At no cost to either the sponsor or CRO, ISS provides access to hundreds of experienced research sites, pre-qualified for US and global trials based on protocol requirements. Investigators join ISS at no charge and benefit from a continuous stream of new trials matched with their interests and capabilities. Sites remain independent and contract on a study-by-study basis, paying a percentage-based fee only upon selection and payment from the sponsor.

ISS also represents a healthcare call center specializing in patient recruitment and related clinical trial services. Multilingual nurse and lay operators, Interactive Voice Response System (IVRS), and Web-based screening tools pre-qualify callers according to study inclusion/exclusion criteria. Call center solutions include a full range of patient retention and compliance programs, fulfillment services, and custom-tailored data management and reporting options. For more information visit www.ResearchSite.net.

Dr. Saurendra Das of Excel Life Sciences named Finalist for 2008 GCPj Awards “Clinical Research Professional of the Year”

Chicago, IL. - Excel Life Sciences, a U.S.-based, India-focused provider of comprehensive trial management services, announces that Executive Director of Operations Dr. Saurendra Das has been chosen as one of five finalists of the 2008 GCPj Awards “Clinical Research Professional of the Year”. The GCPj Awards has been developed to recognize excellence in the Clinical Trials industry.
Now in its second year the GCPj Awards honors and reward corporate and individual excellence and celebrates innovation throughout this industry, with 12 carefully planned award categories.

The GCPj Awards are open to anyone working within the Clinical Trials arena and will culminate in a black tie event with industry leaders where the Awards will be presented. “I have had the privilege of knowing and working with Dr. Das for many years. Dr. Das is an extremely valuable part of the executive team and our success at Excel Life Sciences. His experience in the field of clinical research has helped train hundreds of clinical research professionals in India. We are proud of his nomination and thrilled that he has been chosen a finalist by the GCPj awards for Clinical Research Professional of the Year,” said Dr. Vijai Kumar, President and Chief Medical Officer of Excel Life Sciences.

Dr. Das has over 10 years of experience in coordination of all phases of global and domestic clinical trials. He is a key leader in a large movement underway to make India a premier destination for clinical research in the months and years ahead. His passion for clinical research and for making Excel Life Sciences and India successful is arguably one of the most impressive in the business. He drives himself relentlessly to help build and expand ELS and the greater India clinical research enterprise by applying an impressive work ethic, dedication to learning and training, priority on ethical conduct of clinical trials and the advancement of healthcare across class and income lines throughout India.

Prior to joining Excel Life Sciences, Dr. Das was personally responsible for establishing two major SMOs and one CRO in India. He has led large clinical operations teams and brought many innovations to the field including strategies, systems and processes for faster enrollment and increased retention. Dr. Das’ vast experience includes designing and reviewing clinical trial related SOPs and WPDs, designing SOPs for Ethics Committees, budgeting for Clinical Trials and setting up Central Pharmacies. He coordinated the clinical trials at the two sites that successfully passed the first US FDA audit in India. As an active trainer, he worked closely with faculty from Harvard Medical International developing a global training program and has personally trained hundreds of pharma, CRO, SMO, Central Lab and Site employees in ICH-GCP. Dr Das has worked on the faculty of the CDSCO, WHO and ICRI. Dr. Das holds an M.D. in clinical pharmacology from M. K. C. G. MedicalCollege in Orissa, India.

Other finalists in the “Clinical Research Professional of the Year” category are Dr. Janice Albrecht, Vice President, Clinical Research at Schering-Plough; Dr. Naida Gurshumov, Director of Clinical Research at superDimension Ltd.; Dr. Gordon Kapke, Senior Director, Biomarker Services, Covance, Inc.; and Prof. Dr. James Stegmann, Chief Medical Officer, CardioVascular BioTherapeutics, Inc.

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 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