Agility Clinical, a specialist consulting and clinical-research organisation set up in Carlsbad, US last April, has beefed up its consulting services to offer a broader range of strategic and operational support to its client base of small and virtual biopharmaceutical and medical-device companies.

Founded by David Hale, chairman and chief executive officer of Hale BioPharma Ventures, and equipped with an executive management team of industry veterans including Ellen Morgan, Marilyn Carlson, Elizabeth Ludington, Kristi Clark and Ali Sadighian, Agility says it has added “significant resources” to its consulting offering in response to client demand.

The business provides “a centralised 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”, commented Morgan, who is Agility’s chief executive officer (CEO) while Hale serves as chairman of the board.

Morgan previously co-founded and was CEO and chairman of Synteract, a California-based clinical research organisation also based in Carlsbad, California.

Staffing support

Agility’s consulting services extend across all stages of the clinical development process, from regulatory strategy to electronic submission, with expertise in areas such as chemistry, manufacturing, and controls (CMC), toxicology and pharmacokinetics.

The offering also includes executive-level support and staffing, with the capability to deliver experienced staff for positions such as chief medical officers or heads of project management, biostatistics and regulatory affairs on a temporary or contract basis. 

In addition to consulting, Agility provides customised full clinical-trial services including project management, clinical operations, data management, biostatistics, medical, regulatory and scientific affairs, medical writing and electronic source records.