Our courses have been prepared keeping in mind the current Clinical Research industry requirements so that the deserving candidates can imbibe all the desired concepts of the Clinical Research.
Clinical Data Management assures collection, integration and availability of data at appropriate quality and cost during and after Clinical Trials.
Pharmacovigilance is the pharmacological science related to the detection, assessment, understanding and prevention of adverse effects.
Medical Writing is a growing field with more and more writers looking to specialise in a niche, the health & medical writing field continues to increase in popularity.
This Advanced Regulatory Affairs training program has been conceptualised and designed to meet the growing demand of the industry for professionals providing regulatory affairs and/or quality assurance training.
Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed.This Program offers an Insight about the Clinical Research Medical Coding processed with the help of MedDRA & WHODD.
The objective of the ICH GCP guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
The Health Insurance Portability and Accountability Act of 1996 was enacted by the United States Congress and signed by President Bill Clinton in 1996. It was created primarily to modernize the flow of healthcare information, stipulate how Personally Identifiable Information maintained by the healthcare and healthcare insurance industries should be protected from fraud and theft, and address limitations on healthcare insurance coverage.
Centralized monitoring is a remote evaluation of the study data, carried out by a team including central monitors and medical reviewers at a location other than the sites at which the clinical investigation is being conducted. Centralized monitoring process can give many of the capabilities of on-site monitoring as well as additional capabilities.