Introduction A well-designed clinical trial can be significantly delayed — sometimes by six months or more — before a single patient is enrolled, if the Clinical Trial Application submitted to CDSCO is incomplete, inconsistent, or non-compliant. In India’s regulatory environment, where CDSCO is applying increasingly rigorous review standards under the NDCT Rules 2019, the quality
Informed consent in clinical research is a cornerstone of ethical regulatory compliance. It ensures that participants voluntarily decide whether to take part in a study after receiving adequate information about its purpose, procedures, risks, benefits, and alternatives. It is an ongoing process that promotes transparency, protects participants’ rights, and supports autonomous decision-making. Introduction Informed consent
India has long been recognised as a preferred destination for Phase III clinical trials. What is less widely understood is that it has quietly become an increasingly compelling destination for early-phase clinical trials—Phase I and II studies — and that the regulatory and operational environment behind this shift has matured substantially. The New Drugs and
