Who We Are
Global Clinical Operations
ClinicalRM offers clinical and regulatory operations for Phase I-IV trials most intensively in the US and in Africa, but also in other regions of the world. We are a full-service CRO offering a complete panel of the services needed to conduct GCP-compliant clinical trials including study design and protocol development, regulatory consultations and submissions, site selection, data management, clinical monitoring, quality assurance, medical writing, and staff training, etc. Together with ICON, we augment our capacity and services to manage operations for trials of any size, location, and indication.
On-site Professional Staffing
Today, over 400 ClinicalRM employees currently staff laboratories, GMP manufacturing facilities, clinical trials centers, biomedical research laboratories, and regulatory affairs offices all serving the mission of generating new medical products for the warfighter. These employees have participated in the conduct of more than 200 clinical trials for more than 60 investigational products for a wide range of diseases that affect the warfighter and the lay public.
Together with ICON, we now offer staffing solutions across all aspects of clinical research and medical product development for federal and commercial clients.
Gateway to Africa
ClinicalRM has its beginnings more than 20 years ago working with the US Army in Kenya to aid in development of treatments and preventions for malaria. Building on that heritage, ClinicalRM continues to participate in clinical trial operations for the military, NGO, and Biopharma. With offices in key locations in West Africa and a strategic partnership with ACE Research, a Pan-Africa CRO headquartered in Kenya and operating across Africa and parts of South East Asia, we have the experience and capacity to offer complete end-to-end services, managing all clinical, regulatory, laboratory, and logistical issues in the conduct of Phase I-IV trials. African clinical trial capacity and the range of indications targeted by pharma is rising exponentially with growing populations in need of new treatments for tumors secondary to chronic viral infection as well as other disorders common in western medicine. To date, we have served more than 10,000 subjects in GCP compliant Phase I-IV clinical trials conducted in more than 20 African countries with focus on infectious diseases, sickle-cell anemia, and oncology.
Strategic Consulting and Biotech Acceleration
Through our heritage in the military research corridor and through alliances with world-class university researchers at Case Western, UNC and others, we have established a strong network of consulting physicians and scientists with expertise in clinical research. Through those beginnings, a Medical Experts Office, was built which now offers consulting services for clinical trial design, regulatory strategy, and all aspects of medical product development. Strategic consulting services are offered through members with decades of experience in biotech and pharma as well as government research centers. Our Biotech Acceleration Program is focused on creation and execution of a pre-IND through End of Phase 2 strategy that minimizes time to proof-of-concept. Value is built through careful and informed decisions about resource allocation, study design, manufacturing, and integrated timing for a program that gives the product the best chance for success, maintains safety and compliance requirements, and manages spending to maximize the ROI and an opportunity for early evidence of efficacy and safety.
Logistics and Capacity Building in Challenging Territories
We have established a network of accredited laboratories in strategic locations in Africa and South America. We have also built laboratories to support disease surveillance, custom analytical services, and research in underdeveloped locations. Our logistics services have the experience and on-the-ground contacts to support clinical research efforts in challenging or hard to reach or places. In Africa, we offer logistics and study support (e.g., medical and scientific, facilitation of shipments, ground and air support, infrastructure development and maintenance, vehicles and drivers). We also provide in-country GCP, GLP, and other training, laboratory construction, and annotated biological sample repositories.