Seasoned Industry Expert Gail Adinamis Named CEO of New Organization Focused on Mobile Network of Clinicians to Provide In-Home and Alternate Site Clinical Trial Visits
CHICAGO & DENVER--(BUSINESS WIRE)-- FlexCare Clinical Research, LLC (FlexCare) announced today formation of the company, a niche clinical service provider focused on providing study visits in the home or alternate site settings via a network of highly skilled clinicians.
FlexCare was created to meet growing demand from the biopharmaceutical industry to accelerate clinical trials and streamline study processes. Traditionally, clinical trials are conducted at investigative sites such as hospitals or clinics, where patients are required to travel for protocol-related tests and assessments throughout the duration of the study. Consequently, as a result, for decades, patient recruitment and retention have remained among the greatest challenges in the timely completion of clinical trials.
FlexCare’s service model is designed to take the study to the patient, where protocol activities can be conveniently conducted in their home or at other alternate locations. The utilization of mobile clinicians fosters an increase in the number of patients willing and able to participate in clinical trials, as well as an increase in patient compliance and retention. This results in faster completion times and a significant return on investment for sponsors.
In-home clinical trial visits are particularly beneficial in difficult to reach populations such as among patients with rare diseases who live remote to study sites; and those with cancer or other debilitating diseases who may be too ill to travel. FlexCare’s services also benefit pediatric or geriatric patients, students and working adults who find participation in traditional studies inconvenient.
FlexCare centrally manages study visits that are conducted by its network of highly skilled traveling clinicians expertly trained on the clinical study and regulatory requirements. Services offered by FlexCare include study drug administration, blood draws and other biologic sample collections, clinical assessments, questionnaires and training at the patient’s home or other convenient location.
FlexCare further enhances the quality of its services to study sponsors by employing experts in regulatory affairs, quality assurance, clinical trials operations, home healthcare and clinical data management. Collectively, the FlexCare management team boasts more than 50 years of in-depth industry-related experience, and is dedicated to establishing high standards for quality in clinical trials conducted in the home or at alternate sites.
With the company’s launch, Gail Adinamis was named to the role of chief executive officer, providing vision, leadership, strategic planning and oversight to the company. Adinamis is a seasoned executive and entrepreneur with three decades of comprehensive phase I-IV clinical trials experience. Most recently, Adinamis founded and served as president and CEO of Clinical Resource Network, LLC, a niche clinical trials service organization providing a network of mobile clinicians. During the course of her career, she also managed global trials for Abbott Laboratories and Astellas Pharma (formerly Fujisawa Pharmaceuticals) and headed divisions for clinical trial services for three national home infusion companies including Caremark, Coram Healthcare and Option Care, Inc. Having established this model in 1992, Adinamis is believed to be the pioneer and thought leader for the central management of in-home and alternate site clinical trial services.
Concurrent with Adinamis’ appointment, Dr. Gizelle Baker was named chief operating officer and Dr. Debbie Wilkerson, chief scientific officer. Both are officers at OmniaVincit, LLC, a Denver-based full-service contract research organization. Dr. Baker will focus on overseeing business operations and quality management and brings extensive experience in the building and implementation of data management and analysis systems and data models as well as developing standards and integration procedures that ensure accuracy and consistency.
In her new position, Dr. Wilkerson will be responsible for business development, vendor relations, clinical operations management and regulatory affairs. Wilkerson is a biochemist with broad regulatory and clinical trials experience at the sponsor level, within the FDA-regulated environment.
“FlexCare’s novel service model provides patients a convenient and comfortable means for participating in clinical trials and sponsors the opportunity to enhance enrollment and ensure compliance. Taking trial testing into the patient’s home broadens the geographic reach for potential study participants and addresses two of the greatest challenges in clinical development: patient recruitment and retention. With faster recruitment and better retention, studies are completed more quickly, bringing products to market sooner. Conducting studies in a real-life environment also provides valuable predictive information to sponsors and regulatory authorities on how products may perform once available in the marketplace. With an emphasis on healthcare reform, payers are seeking low-cost, safe and effective means to best manage patients. Treating them in their home can be considerably more cost-effective than performing similar services in an office or hospital setting,” Adinamis explained.
FlexCare Clinical Research, LLC, with offices in Chicago and Denver, and affiliates in Europe, offers specialized in-home and alternate site clinical services throughout the United States and internationally. These services aid in accelerating clinical trials using an extensive network of highly skilled and trained mobile clinicians able to conduct study visits at locations convenient to patients. FlexCare is a provider to biopharmaceutical and medical device companies engaged in all phases of product development, across a variety of therapeutic areas and helps to enhance patient recruitment, retention and data collection while ensuring compliance. For more information, please visit www.flexcarecr.com.
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