CARLSBAD, CA – November 13, 2012 – Agility Clinical, Inc., a specialty consulting and clinical research organization, has expanded its stand-alone consulting services to more broadly serve the unmet needs of small and virtual biopharma and device companies. The firm helps pre-clinical and clinical stage companies with a lean infrastructure develop drugs and devices by providing strategic and operational consulting support, in addition to traditional CRO services.
“Seasoned industry expertise is essential to deliver value to a sophisticated life science client, and we are very excited to have been able to assemble such a talented and experienced group of individuals. We can provide expert strategic and operational consulting support to our clients at all stages of clinical development,” says Ellen Morgan, CEO of Agility and a 30-year industry veteran. “Agility provides a centralized location where companies can get sound advice that is often vital to their clinical development plans with the ability to respond rapidly to changes and challenges.” Morgan co-founded and was CEO and chairman of Synteract, Inc., a California-based CRO that grew to over 300 employees and provided clinical services to hundreds of companies during her tenure.
Responding to requests from their client base, Agility has added significant resources to its consulting offering which covers all stages of the clinical development process from regulatory strategy to electronic submission, including among other areas, expertise in chemistry, manufacturing, and controls (CMC), toxicology, and pharmacokinetics. Agility also includes executive level support and staffing in its services, with the capability to provide experienced people in positions such as Chief Medical Officer (CMO) or heads of Project Management, Biostatistics and Regulatory Affairs, on a temporary or contract basis.
“Our goal is to provide guidance and proactive solutions for small and virtual biopharma and device companies so that their product development programs are successful within their timelines and budget constraints,” says Marilyn Carlson, D.M.D., M.D., RAC, Vice President of Medical, Regulatory and Scientific Affairs at Agility.
Agility was founded in April 2012 with an experienced executive management team whose mission is to help small and virtual pre-clinical and clinical stage companies develop drugs and devices. In addition to consulting, Agility provides customized full clinical trial services including project management, clinical operations, data management, biostatistics, medical, regulatory, and scientific affairs, medical writing and electronic source records (ESR). The Agility team has a true appreciation for the challenges virtual companies face in obtaining dedicated expertise they need. Agility has established operations in Carlsbad, CA. For more information, please visit www.agility-clinical.com.