GlobalCare Clinical Trials Chooses bioaccess.™ to Expand its Ambulatory Services to Colombia
[ORLANDO, FL., March 22, 2019] — GlobalCare Clinical Trials, LLC (“GCCT") has executed an agreement with bioaccess.™ to expand its clinical trial ambulatory services to Colombia. Under this agreement, GCCT will leverage bioaccess.™ extensive presence in Colombia to expand its ambulatory service offering in Latin America in support of its global pharmaceutical clients that need GCCT to assist them with their clinical trial patient in-home needs in Colombia. Reduction in clinical trial subject recruitment time by over 50% and an increase in subject retention rate of over 95% are among the results that have spurred GCCT's rapid growth.
GCCT 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. GCCT'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 GCCT 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, GCCT 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.
GCCT has been involved in over 400 trials in over 50 countries. The company 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. GCCT's 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. GCCT'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.
Therapeutic areas that tend to benefit the most from GCCT's model include, but are not limited to, oncology, neurology, infectious disease and the central nervous system. GCCT's services are also advantageous for the support of orphan drug studies, where patients typically live significant distances from investigative sites. GCCT 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.
GCCT is led by Gail Adinamis; its founder, President, and CEO. Mrs. Adinamis has over 35 years of comprehensive phase I-IV clinical trials experience including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She founded the business model for centrally managed homecare services for clinical trials in 1992. Established and served as president of the clinical trials divisions for Caremark, Inc. Coram Healthcare and OptionCare Inc. and was founder, President and CEO of Clinical Resource Network, LLC.
Thanks to GCCT's agreement with bioaccess.™, GCCT will have a country coordinator in Colombia so that GCCT's clients are able to take advantage of GCCT's capabilities, allowing them to experience shorter subject recruitment rates, and a significant increase in subject retention rates.
About GlobalCare Clinical Trials, LLC
GlobalCare Clinical Trials, LLC Ltd brings over 100 years of experience in the clinical trials and home healthcare industries supporting over 400 trials in 50 countries by effectively delivering high quality and convenient clinical trial services in the home or alternate-site setting. GlobalCare was recently awarded as one of the fastest growing women-owned/led organizations in the U.S. GlobalCare maintains a global clinical network of ambulant clinicians and country coordinators and operates offices in North America and Europe. GlobalCare supports phase I-IV clinical trials in a variety of therapeutic areas, genomics and personalized medicine in all age groups. GlobalCare also provides a variety of site support services. For more information, please visit www.globalcarect.com.
bioaccess.™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company provides its clinical research clients with support services to ensure their first-in-human trials are a success in Colombia (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). For more information, please visit www.bioaccessla.com.
bioaccess.™ Press Contact:
Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210