Role of contract research organization in clinical research management

Contract research organizations (CROs) conduct clinical researchon behalf of the pharmaceutical, biotechnology, and medical device industries (sponsors). Clinical trials are a CRO’s core competency just as the pharmaceutical company’s core competency is usually developing drug pipelines and marketing. Professionals in these organizations utilize their expertise in scientific, regulatory and information management and aim towards the completion of timely, accurate, and cost-effective trials.

The pace of drug discovery in recent years has resulted in an enormous pressure on the drug development process. Outsourcing the clinical research to third parties is being increasingly viewed as an effective option to partially overcome the development related constraint.

When CROs were first formed, they were outsourced selected aspects of clinical trials to work on. These organizations worked as highly specialized entities, providing, for example, either bio-statistical advice, clinical researchassociates who monitored investigational sites for regulatory compliances, or regulatory support. Gradually, they emerged as fully functional organizations offering all services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, data management, and biostatistics.

A typical CRO’s functional set-up consists of four major departments. These include clinical operations, clinical project management, medical affairs, and biomedical operations. Quality control is usually an independent department, or an independent part of each department.

Clinical research is the trending field that has marked India’s prominence at the global level. The CROs here have been adopting techniques to match international standards, including voice-response data collection systems and web-based clinical trials platforms.Recent US-Food and Drug Administration (FDA) audits have been a big boost to the transition of clinical research towards Indian cities. According to FDA, India provides better quality of trials and higher recruitment rate, and pays more attention towards the protocol-based study, informed consent issues, and adverse event reporting than many other countries.

Instead of a full-service CRO model, many clinical research organizations are now adopting the dedicated site management model. If you are looking for a company that can place a dedicated clinical research coordinator(CRC) at every research site to help the investigator manage the study better, the author of this article suggest Excel Life SciencesPvt Ltd, a dedicated site management organization.

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