Contract Research Solutions

Undue delays in drug discovery development times, prolonged regulation-mandated testing and complex review processes, increasing R&D expenditure and intense industry competition are compelling pharmaceutical companies to look at contract research services from highly skilled destinations like India.

New compliance regulations such as GCP (good clinical practice) and GLP (good laboratory practice), along with EC, ICH and OECD guidelines are mandatory in clinical research and drug development processes. This has made drug research processes very time consuming and expensive for pharmaceutical companies. Pharmaceutical companies in the U.S. and Europe, where regulatory requirements are extremely stringent, are increasingly looking at outsourcing their research processes to external research bodies or 'contract research organizations' (CROs).

Contract research is the process of contracting out specific research activities and processes in a pharmaceutical company to an external research body. Some of the reasons for the growing popularity of contract research services are:

• Strict regulatory standards and compliance requirements
• Escalating research costs
• Intense competition in the pharmaceutical industry
• Need to reduce drug development cycles
• Increase manufacturing costs pushing down revenues of pharmaceutical companies
• Need for multi-disciplinary research in specialties such as biosciences, genetics, molecular-cell biology, synthetic chemistry, microbial genomics informatics, manufacturing and technology.

Contract Research Services

Contract Research Organizations are becoming important strategic partners for pharmaceutical companies as they help pharmaceutical companies to transition new drugs from concept stage to FDA marketing approval without the pharmaceutical company having to invest time, money and people for these services.

The following are covered under contract research services:

• Animal studies
• Research in drug development and discovery
• Toxicology studies
• Clinical trial management from Phase 1 to Phase 4 (including study startup, monitoring and closeout),
• Customized research and development
• Clinical bio-equivalence studies
• Pre-clinical trials
• Regulatory data generation
• R&D data management
• Carcinogenicity and mutagenecity studies
• Small molecule synthesis studies
• Biostatistics
• Medical writing
• Compliance management
• Drug approval submissions
• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)

Software Tools for Contract Research and Clinical Trial Software

With the rapid growth in contract research, a large number of innovative pharmaceutical software solutions and products are being developed in India to meet the needs of the clinical research fraternity. Advanced contract research software tools are being developed that enable researchers to build, visualize, and analyze molecular models on your desktop. Software vendors are rising to the challenges to meet the increasing demand for clinical trial management software and clinical research data management software.

Software solutions for contract research include a wide variety of other tools and platforms such as:

• Advanced simulation and informatics software
• Chemical information management systems
• Molecular analysis software
• Software for compliance and validation O2I
• In silico toxicity prediction
• Pharmacokinetics, ADME analysis
• Modeling, database management, and querying tools for drug discovery
• Modeling and simulation for materials and chemicals research
• Advanced macromolecular X-ray crystallography
• Simulations Modules
• Chemical databases
• Clinical Research Data Management Software
• Clinical Trial Management Software

India: A Preferred Destination for Contract Research Outsourcing

India's total contract research revenues is expected to grow at 23.6% CAGR, touching USD 175 million by end 2010. "The rapidly evolving skill-set of Indian vendors in basic research and development have narrowed the skill-gap required for NCE research. This trend is one of the key attractors for western companies to outsource value added research services from India", believes Dr Raj Rajagopal, CCO KnowGenix.

Indian companies are providing excellent contract research services to global pharmaceutical companies. Some of the benefits that these companies find in contract research outsourcing to Indian service providers are:

• Low costs of research for conducting clinical trials
• IT skills and infrastructure
• Presence of pioneers such as Biocon India Group
• Leverage India's competitive advantage in software skills
• Intellectual talent pool in biosciences
• Large and diverse patient pool
• Advanced medical fraternity and healthcare practices

Today, pharmaceutical companies are not asking 'whether' they should offshore contract research to India, but are instead deliberating on 'which phase' of the drug discovery process has to be sent to India so that they can best leverage the India advantage.

Outsourcing Contract Research Services to India: Benefits

There are already 20 contract research organizations functioning from India providing a range of cutting-edge services. Global pharmaceutical companies stand to gain from the following factors by outsourcing research to India:

• Effective and quicker clinical trials at much more competitive rates
• India's strong intellectual base in biosciences
• Commitment to high ethical standards
• Strong IPR (Intellectual Property Rights)
• Awareness and adherence to GCP and GLP requirements

Contract Research Outsourcing: Industry Trends

Indian contract research organizations are focusing on moving up the value chain by becoming 'preferred vendors' to a few global outsourcers rather than servicing a large number of companies. Contract research services from Indian research and pharmaceutical companies are mission critical research and developing proprietary technologies for global counterparts. Contract research organizations are expanding their geographical base and service portfolio through acquisitions, licensing arrangements and collaborative research.

Read more about the advances in Drug Development Technologies.

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