| |
| Bangalore, November 10, 2006 - Manipal AcuNova Ltd, the first Indian CRO to be ISO 9001 certified, today announced the receipt of the prestigious National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation to its Central Reference Laboratory at Bangalore. The ISO 15189:2005 accreditation has been given by the Department of Science & Technology (Government of India) for Diagnostic Testing. |
| |
| NABL is the only accreditation body in India for pathology laboratories. In one year, Manipal AcuNova has completed the certification process for two of its laboratories. Manipal AcuNova's Central Reference Laboratory specializes in Patient Testing, Advanced Molecular Diagnostics and Clinical Trial Testing. |
| |
| On achieving this benchmark, Dr. P.K. Menon, MD, PhD, Vice President- Central Reference Lab, said " We comply to ISO 15189 for clinical standards, to ISO 27001 for information security standards and to ISO 9001 for managerial requirements. NABL is an assurance to our clients, that the lab quality and competence meets global standards. Central Lab is a distinct feature available with few CRO's providing sponsors and patients with better project management on trials. This accreditation has opened a host of other exciting opportunities for participating in transnational reasearch, thereby defining markets without boundaries." |
| |
| Speaking on the accreditation and the way forward, Mr. D A Prasanna, Vice Chairman and MD said,"Since our inception, the company has grown manifold in a short span of time. Manipal AcuNova is now catering to international trials as well as provides a lucrative advantage for international alliances. Our existing partners, global regulators and allies see this achievement as a requirement and we are happy to raise the bar of quality in this space. At the macro level, it is our endeavour to showcase 'India advantage' as not just cost oriented but also as a Country driven by quality. This accreditation is key driver towards this agenda." |
| |
| About NABL accreditation: It is a formal recognition of the technical competence of a pathology laboratory for a specific task following ISO 15189 standard. This is based on third party assessment. WTO recognizes non-acceptance of test results and measurement data as Technical Barrier to Trade (TBT). Accreditation is considered to be the first essential step towards removing such technical barriers. NABL has gone a step further and achieved the status of APLAC (Asia Pacific Laboratory Accreditation Cooperation) MRA (Mutual Recognition Arrangement) partner and signatory to ILAC (International Laboratory Accreditation Cooperation) arrangement based on peer evaluation by a multi-disciplinary team from APLAC. This is a step towards mutual acceptance of test results and measurement data amongst 52 accreditation bodies representing 45 countries. NABL accredited laboratories have therefore emerged as a member of global association of accredited laboratories. |
| |
| About the Central Reference Lab: |
| |
| Known as a" Thinking Lab" , it offers patients advanced molecular and esoteric diagnostic services along with conventional testing. For pharma and biotech clients the Central Reference Lab offers custom tailored studies using molecular and cellular sciences. In addition, laboratory services are provided at all stages of clinical development- from pre-clinical to phase IV trials. The lab caters to: |
| |
| Patient testing service: Some of the advanced equipments used are Olympus for Biochemistry analysis and Beckman Coulter analyzer for haematology The lab offers Viral loads for HIV, HBV, HCV using real time PCR, genotyping HCV and HBV. Other tests offered include Immunohistochemistry, immuno-fluorescence assays amongst others |
| |
| Clinical trial lab service: These include test design & statistical validity; regulatory consultation; import of kits, reagents, samples, required for clinical research; investigator briefing; providing central lab service and archival. |
| |
| Pharma Company research testing service: Drug to drug reaction, efficacy in a genetic type, immunology, HLA matching, biomarkers, are some areas where Manipal AcuNova can provide insight. The company's biostatisticians provide advice on sample size. |
| |
| Notes to the editor: |
| |
| About Manipal Acunova www.acunovalife.com |
| |
| Manipal AcuNova Ltd is a comprehensive, single source provider of clinical research and related services in the areas of Bio Availability and Bio Equivalence, Phase I - IV clinical trials, Clinical Data Management and the Central Reference Lab. Manipal AcuNova has access to Manipal's 19 research sites, known to be Asia's largest academic medical centre treating 1.5 mn patients with 1500 physicians. The company has been awarded as India's No 1 emerging CRO in 2005 by Proximare Inc. (A New Jersey based strategic Consulting firm).Manipal AcuNova has research facilities in Bangalore, Mangalore and Manipal as well as a wholly owned subsidiary in the US and UK. The quality standards conform to ISO, DCGI, ICMR, and ICH GCP guidelines |
| |
| About NABL |
| |
| National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of the Department of Science and Technology, Government of India. NABL has been established with the objective of providing Government, Industry associations and industry in general with a scheme for third party assessment of quality and technical competence of testing and calibration laboratories, thus providing a ready means for customers to find reliable testing and calibration services to meet their demands. |
| |
| For further information, please contact: |
| |
|
