Manipal AcuNova Ltd's Central Reference Laboratory has been awarded an accreditation by the Commission on Laboratory Accreditation on the College of American Pathologists (CAP), based on the results of a recent on site inspection.
Manipal AcuNova provides phase I - IV clinical development services including project management, CDM, biostatistics, medical writing, BA/BE and Central Lab. With research facilities in Bangalore, Mangalore and Manipal, MAL is a University backed CRO with preferred access to Manipal Medical University 's 19 teaching hospitals.
Manipal Medical University is Asia's largest academic medical centre treating over1.5 mn patients with more than1500 physicians. MAL was selected as the 'Partner of Choice' for BA/BE studies by Frost & Sullivan for quality of services. MAL is ISO 15189 certified for clinical standards, ISO 9001 for managerial requirements and ISO 27001 for information security. The labs in Bangalore and Manipal are CAP compliant and ISO certified. The phase I facility has been audited by US FDA. The company has been awarded as India's No 1 emerging CRO by Proximare Inc. New Jersey.
According to D A Prasanna vice chairman and MD of Manipal AcuNova said "CAP accreditation is an endorsement that our Patient testing work is of global quality. With CAP, our testing service will be more assuring to Pharmaceutical company clients to file the research results with US FDA.
Since 2003, CAP accreditation has been becoming popular in India beginning with Clinigene, a Biocon subsidiary that became the first CRO to get this recognition. Now with Manipal AcuNova's joining the bandwagon, the total number of CAP approved labs in India is ten.
The CAP Laboratory Accreditation programme began in the early 1960's, is recognized by the US Government as being equal to more stringent than the Government's own inspection programme.
During the CAP accreditation process, inspectors examine the laboratory's records and quality control of the preceding two years. CAP inspectors also examine the entire staff's qualifications, the laboratory's equipment, facilities, safety programme, records, as well as the overall management of the facility. This stringent management program is designed to specifically ensure the highest standards of care for the laboratory's patients.
The College of American Pathologists is a medical society serving nearly 16000 physician members and the laboratory community across the world. It is the world's largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance.