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| Bangalore, December 19, 2006: - Manipal AcuNova Ltd, the first Indian Clinical Research Organization(CRO) to be ISO 9001 certified, announced the receipt of the prestigious ISO 27001: 2005 by Underwriters Laboratory. Data generated in clinical trials is analysed by biostatisticians to arrive at the safety and efficacy of new drugs. CRO's report such information to drug companies and regulatory authorities. ISO 27001 assures that this is done meticulously and integrity can be checked through an audit. Manipal AcuNova is the first CRO in India to receive this certification assuring clients on confidentiality and integrity of data generated from clinical research |
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| Dr. Krathish Bopanna, Vice President Clinical Development & Chief Technology Officer said 'we as a CRO handle sensitive information on success or failure of new drugs. Release of clinical research results to community should be done only by drug company. Inadvertent release of positive information raises patient hopes. Any leak of negative information can harm research and reputation of drug company. Regulators require that there is no inadvertent release of research information. ISO 27001 assures that process, systems and control in a CRO are sound to protect information integrity and confidentiality' |
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| Speaking on the occasion, Mr D A Prasanna, Vice Chairman and MD, said, "With India being an IT and clinical trials hub, outsourcing to India for clinical data management is growing. Anxiety of drug companies on information security hinders this growth. With ISO 27001, Manipal AcuNova gets the first mover advantage in adopting global standards. We expect more drug companies to get data management work done in India by companies like us" |
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| Manipal AcuNova Clinical Data Management Manipal AcuNova provides comprehensive data management in pre clinical, bio-equivalence, phase I -IV clinical trials, pharmacovigilance, remote radiology, cardiology and ECG imaging. The company aims towards transforming raw data into consistent, accurate, reliable, meaningful trial output in full compliance with regulatory guidelines. The services offered span every phase of the drug development process. |
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| About ISO 27001:2005: |
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| ISO 27001 is the formal standard charting out the requirements for an Information Security Management System (ISMS). ISO/IEC 27001:2005 is the updated version of the world renowned British Standard for Information Security Management Systems, BS 7799-2:2002. Having become an international standard, it has now gained global recognition. The standard covers all types of organizations. It specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving documented ISMS within the context of the organization's overall risk management processes. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof. The standard provides an ISMS model for adequate and proportionate security controls to protect information assets and give confidence to interested parties |
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