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Before the financial crisis of 2007–2008, 75% of the candidate that outsourced services were small and mid-sized biotechnology and pharmaceutical companies. [5] Following the financial crash in 2008 the CMO industry started to be funded by private equity as a result of a substantial growth and a more qualified management. [6]
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
PPD was founded by Fred Eshelman, Pharm.D., as a one-person consulting firm in 1985. The following year, he expanded the company's scope to include development services and relocated operations from Maryland to North Carolina. July 1985: Fred Eshelman, Pharm.D., founds PPD as a one-person consulting firm based in his home in Maryland.
The Outsourcing Facilities Association, another industry group that represents compounders that produce large batches of medications, has sued to overturn the FDA's decision.
KCR was established in 1997 as Kiecana Clinical Research. The company provided services for clinical monitoring, clinical project management, safety/pharmacovigilance, regulatory affairs and quality assurance. In April 2014, KCR launched KCR Placement, which offers recruitment and outsourcing for pharma and biotech in Europe. [2]
Fortrea Holdings Inc. is a contract research organization organized in Delaware and headquartered in Durham, North Carolina with operations in 90 countries. Its customers are primarily in the pharmaceutical, biotechnology, and medical device industries.
In February 2015, AMRI acquired SSCI based in West Lafayette, Indiana. SSCI was founded in 1991, providing comprehensive cGMP solid state chemistry research and analytical services to the pharmaceutical industry. Servicing more than 250 customers a year. [25] [26] In July 2015, the company acquired Gadea Pharmaceutical group for $174 million. [27]
IQVIA is a provider of biopharmaceutical development, professional consulting and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including investment strategy and management consulting services.