CHICAGO, March 9, 2011 /PRNewswire/ -- GlobalCare Clinical Trials, Ltd, (GlobalCare) today announced its expansion into Latin America. GlobalCare provides selected clinical study visits at convenient locations – such as in the home or alternate settings – for study patients to support phase I-IV trials in a variety of therapeutic areas, genomics and personalized medicine in all age groups. GlobalCare's patient-centric service model provides faster patient recruitment, better protocol compliance and higher retention rates, while helping to decrease the cycle of time to biopharmaceutical development and speed delivery of life-enhancing products to market for the benefit of patients worldwide.
Regulatory-compliant services provided by GlobalCare include: global project management; study drug administration; blood and other biologic sample collection; clinical assessments; patient training and education; device management; source documentation; and data collection. In addition, the company offers central and local out-patient pharmacy services including storage and distribution, compounding and dispensing, cold chain logistics, and sourcing of commercial products and devices.
Serving the Globe
GlobalCare provides services in over 20 countries and maintains a centrally managed network of multilingual country coordinators who are trained and certified on Good Clinical Practice/International Conference on Harmonization (GCP/ICH) guidelines and have in-depth knowledge of local medical practices and country cultural attitudes. The network is augmented by an extensive pool of over 20,000 qualified local traveling physicians and nurses in the United States, Canada, Australia, Europe, Israel, and now Latin America. GlobalCare's model enables patients to participate in clinical trials regardless of study duration; frequency of visits; disease state; distance to site; and/or family, work or community commitments by conducting study visits in a location convenient to them.
"GlobalCare continues to expand its network based on client demands, and Latin America has become one of the most prominent new clinical trials locations. The standard of medical training in Latin America is high and, due to improvements in the countries' regulatory legislation, investigators are knowledgeable in GCP/ICH guidelines. There are also large numbers of drug-naive subjects. Thus, it made sense to extend GlobalCare's services to this region, cost-effectively delivering high quality and flexible clinical trial services to patients in convenient settings like their home or office," said Gail Adinamis, founder and Chief Executive Officer of GlobalCare.
Reduction in subject recruitment time by over 50% and an increase in subject retention rate of over 95% are among the results that have spurred GlobalCare's rapid growth.
"As industry demand increases for accelerated patient enrollment and streamlined study processes on a global basis, we will continue to expand our network to facilitate the timely and successful completion of clinical trials across biopharmaceuticals while providing important return on investment for sponsors," Adinamis continued.
Therapeutic areas that tend to benefit the most from this model include, but are not limited to, oncology, neurology, infectious disease and the central nervous system. GlobalCare's services are also advantageous for the support of orphan drug studies, where patients typically live significant distances from investigative sites. And, GlobalCare employs an extensive screening and qualification process for its network members and maintains a rigorous quality management system to promote standardization globally while complying with all applicable regulations.
"In addition to our teamwork, quality and responsiveness, GlobalCare works with an unwavering commitment to patient care, safety and ethics," states Adinamis.
Leadership and Experience
With more than 100 years of collective experience in the clinical trials and home healthcare industries, the GlobalCare team has supported more than 350 trials, including several studies leading to commercialization of blockbuster products. With three decades of comprehensive phase I-IV clinical trials leadership, CEO Adinamis is also the founder and pioneer of the in-home and alternate site clinical trials model, which she introduced in 1992. Adinamis also spent 12 years in global clinical trials management at Abbott Laboratories and Astellas Pharma and established and led clinical trials divisions for three national home infusion companies as well as her former company, Clinical Resource Network, Inc.
Adinamis is joined by Janusz Kabata, MD, PhD, MBA, who serves as Chief Medical Officer and Director of European Operations for GlobalCare. Kabata brings over 30 years of medical experience to the company as an academic researcher and Medical Director in private healthcare institutions. He also provided two decades of work in successful coordination and management of international clinical trials.
About GlobalCare Clinical Trials, Ltd
GlobalCare Clinical Trials, Ltd is a global niche service provider to government agencies and the world's biotechnology, pharmaceutical and medical device companies engaged in all phases of product development. GlobalCare offers an innovative patient-centric service model that provides selected clinical study visits in the home or alternate setting resulting in faster patient recruitment, better compliance and higher retention rates, helping to expedite time-to-market for life-enhancing products. Services are provided in over 20 countries, through an extensive network of multilingual Country Coordinators and over 20,000 local highly skilled ambulant clinicians in compliance with local and national regulations. Services include Global Project Management, local and central pharmacy services, study drug administration, blood and other biologic sample collection, clinical assessments, patient training and education, device management, source documentation, and data collection. For more information, please visit www.globalcarect.com.
SOURCE GlobalCare Clinical Trials, Ltd