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Certified Medical Writer
Certified Medical Writer has the responsibility for creating and maintaining the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. These documents contain records, reports and forms pertaining the preparation process, quality protocols and mandate,clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents that summarize and discuss the data a company gathers in the course of developing a medical product. DURATION : 2 Months -
Certified Clinical Research Associate
This is the first step to understanding the various facets of the clinical research industry. Understanding the Drug Development Process and grasp the importance of Good Clinical Practices (GCP) & to understand the roles and responsibilities of a clinical research team. Reporting audit queries by citing evidence of work. This will establish your role as a clinical research associate in the Industry. You will understand the different regulatory bodies and their common and uncommon ethical practices. DURATION : 4 Months -
Certified Clinical Research Coordinator
Understand the concept of Clinical Research / Trials. Understand Medical Writing and Patient Safety Management. Understand Regulatory affairs and Data Management. Understanding the Drug Development Process and grasp the importance of Good Clinical Practices (GCP) & to understand the roles and responsibilities of a clinical research team. DURATION : 3 Months
