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Current Trends in Biotechnology and Pharmacy Vol. 5 (3) 1353-1361 July 2011, ISSN 0973-8916 (Print), 2230-7303 (Online) Information Technology Consolidation with Virtualization in a Contract Research Organization L. N. Chavali* and V. Sireesh Chandra Vimta Labs Limited, Cherlapally, Hyderabad - 500 051, India *For Correspondence - lnchavali@yahoo.com 1353 Abstract The enterprise server and storage products from most of OEMs like IBM, HP etc support virtualization and continuity, enabling Contract Research Organizations (CRO) to consolidate workloads across diverse operating environments and to deploy new solutions quickly, reliably and with a significantly lower total cost of ownership. The key requirement of the CRO at Hyderabad is that the existing application and database servers be replaced with HP blade and integrity servers, storage and backup solution to be provided for the servers; and replication is setup between primary and secondary sites for database (db) and non-db data. HP solution achieved the disaster tolerence by implementing Metro Cluster for databases and applications. The Lab requires 99.9% high availability for all servers and scientific applications to be migrated from the old platform to the new HP platform. Keywords: Server virtualization, high availability, content management, laboratory information management, database management. Introduction A Contract Research Organization (CRO) is a company or organization that offers a wide range of pharmaceutical services primarily to the pharmaceutical and biotechnology industries. The government defines a CRO as a corporation that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor to design, select, monitor, evaluate, and/ or prepare materials to be submitted to the Food and Drug Administration [21 CFR 312.2(b)]. Services can include but are not limited to: product development, formulation activities, phase I through IV activities, data entry and management, project management, Institutional Review Board (IRB) approval, statistical analysis, and other required activities necessary to apply for a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA). Contract work in basic research has evolved from low-end research activities to more valueadded high-end research. Reputation for research quality and thoroughness, speed to project completion, and strong client relationships are key to success in research partnering. Domain expertise as an entry barrier is restraining contract research partnering opportunities. Availability of top of the line infrastructure and manpower is a defining factor for success in drug discovery contract research. A host of players from Andhra Pradesh (India) are competing for CRO role such as Vimta Labs, Divi’s Laboratories, Ocimum Biosolutions, Actimus Biosciences, Asian Clinical Trials Pvt Ltd, GVK Biosciences Pvt Ltd, iGate Clinical Research International, Sipra Labs Pvt Ltd, etc. Information Technology Consolidation with Virtualization
Current Trends in Biotechnology and Pharmacy Vol. 5 (3) 1353-1361 July 2011, ISSN 0973-8916 (Print), 2230-7303 (Online) 1354 These leading CROs are performing costeffective bio-equivalence / bioavailability (BE/ BA) studies on various dosage forms of pharmaceuticals and to conduct testing services in the areas of clinical research, pre-clinical (animal) studies, clinical reference lab services, agriculture sector, bioscience, environmental assessments and analytical testing of a wide variety of products (1). One of the goals of the CROs is to help its customers reduce the cycle times of new drug discovery by connecting different stakeholders who are geographically distributed using automated clinical trial processes by leveraging technology solutions available on different platforms. In general, the clinical data are collected through a variety of data acquisition systems like Web Forms, telephone interactive voice response (IVR), fax, clinical devices, hospital information and management systems/labs and provide a central storage for the collected data. The data are critical and sensitive and hence the security and privacy needs are high. The data collection and management is a process that is regulated by regulatory authorities and goes through regular audit checks. Life expectancy of the data is driven by customers as well as regulatory authorities. It is traditionally kept for fairly long periods. Over the past several years, however, economic pressures on drug developers have grown and CRO are now seen as a key means to contain ever-expanding R&D costs and shorten time to market by virtue of their ability to achieve economies of scope and scale in the testing process. Therefore, an early adoption of leading edge technologies is one of the key enablers for delivering high quality services and the CROs should have a policy to protect themselves from technological obsolescence by duly validating all technologies deployed. Leveraging new technologies enable to reduce the cost of services and improve the effectiveness of the solutions / services offered to its customers and to help business re-design/re-model its operational processes to take full advantage of the new technologies. The CRO must make sure that the data is protected and secured with a key principle. The aim of all CROs is to see that the objectives mentioned below are met: 1. Seamless access of the applications at Data Center (DC) or Disaster Recovery Center (DRC) 2. Improved infrastructure efficiency 3. More stable environment 4. Flexibility and ease of maintenance 5. Improve the data quality and security Results and Discussion “Data are provided to people on a needto-know’ basis”. The problems for the CRO under study with the existing obsolete infrastructure architecture are agility and gaining competitive advantage and therefore, an adaptive infrastructure solution is necessary to accelerate growth and to reduce costs. The solution proposed for the CRO under study on HP platform can address this problem by providing powerful servers, sophisticated storage systems, and flexible consulting and support services. There are a variety of factors that make the CRO business more challenging than before. Regulators around the world are increasingly asking for more detailed safety and security assessments not only of data in the data center but also on drug candidates. Given below some of the challenges in CRO: Challenge: Improving performance, business continuity, data security and data integrity: To have a consolidated infrastructure model that can deliver applications to its disaster recovery (DR) and services to all its satellite centers while at the same time enabling VoIP and video Chavali et al
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Page 175: (December 7-9, 2011) Venue: Karunya
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