Clinical Trials Infrastructure
Clinical trials are the universally accepted “gold-standard” for generating evidence of efficacy for new treatments and interventions. Regulatory agencies, e.g. Food and Drug Administration (FDA) in the United States, European Medicines Agency in Europe, require well designed clinical trials for approval of new drugs and devices. Other countries may require additional clinical trials to demonstrate efficacy and safety in native populations, even if the drugs or devices are approved in the United States or European Union. Hence, having a robust clinical trials infrastructure, capacity and capability are essential in all countries.
Our principals and consultants have vast experience in designing and leading multi-center, randomized, controlled clinical trials in various settings. We also have extensive experience in putting together the framework and infrastructure for clinical trials and clinical research in general. Our expertise spans all phases of clinical trials, and to putting together the governance, structure, regulatory framework, ethical standards, data safety boards, institutional review boards and post-marketing surveillance. Our experienced team can provide end-to-end solutions or customized solutions for any of the elements required for efficient, ethical and safe conduct of research studies.