Thursday 12 January 2017

Contract Research organizations benefits Clinical Innovation System

In the recent years with growth of CROs in research, partnerships has benefited companies with reduced operational costs, easier regulatory processes abroad, ability to recruit more diverse research participants in a shorter amount of time, faster protocol approval and availability of highly skilled professionals in emerging research markets. Pharmaceutical industries have been increasingly challenged to step up the drug development process. Increased government scrutiny, poor economic conditions, and pricing pressure have led them to watch out for new options for reducing the cost of research and production.

Contract Research Organizations (CRO) plays an important role between the basic researches at academic levels, to applied research in industry. CROs provide support to the pharma industries in research and development process by offering a wide range of capabilities. According to the requirements of trials the CROs provide their services in management and accordingly they facilitate product development, formulation and manufacturing, clinical trial management, medical and safety monitoring, toxicology, and clinical laboratory services for processing trial samples, biostatistics and medical writing services. The CROs also work for filing of NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) to the regulatory authorities for the new or generics drug products. Premium CROs have the potential to add significant benefit to the clinical trial process, including enhanced quality of data collection and trial standards. CROs offer services required for phase-I to Phase-IV trials for a particular project or multiple projects.

On behalf of a sponsor clinical CROs undertake execution of clinical projects. CROs help sponsors to find investigators and recruit patients, and also under diverse sets of regulatory circumstances encourage the clinical trial to proceed with relative clarity. The main role of CROs is to assure compliance to the numerous rules and regulations that must be considered for clinical trials. In this regard CROs hire clinical research coordinators 

who responsibly work upon evaluating any fraud or discrepancy in the documentation followed by ensuring consent procedures and accuracy of data being captured by the investigators. CRCs are also trained in Good Clinical Practices for serving their role in clinical research. At the level of drug assessments CROs provide a range of instrumentation, especially to assess the drug efficiency and other parameters.  More than CRCs, CROs also have medical department with qualified healthcare professionals.

CROs play their role efficiently in the process of clinical trials, and help transform research on human subjects. Maintenance of controls over disclosures and confidentiality make them a better choice for protection of trial information. CROs also help maintenance of Intellectual property rights especially in research toolkit. In the present scenario, sponsors do not increase the overall level of CROs by involving them completely in their clinical projects. But, they only use them for variety of clinical activities.


WorkSure being MedPharma Knowledge and Technology partner to all industries help all phases of clinical trials. Strong medical driven approach at WorkSure helps to create protocol, statistical plan and all other regulatory documentation. The strong IT team and indigenous data management platforms help WorkSure to promote and offer cost elasticity in medical / clinical research. Our strong Clinical research team believes in helping research at all levels and in all budgets without any compromise in end quality. WorkSure supports clinical research, right from concept, protocol to clinical data management, monitoring, till statistical analysis and report.

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