Medical writing for clinical trials is a specialized discipline focused on preparing clear, structured, and compliant documentation required by regulatory bodies such as the FDA and EMA for the approval of new therapies. Its primary function is to translate complex…
A Pharmaceutical Quality Management System (QMS) is a formalized system that directs and controls an organization’s activities to consistently meet both customer and regulatory requirements. It is a framework of processes, procedures, and responsibilities for achieving quality policies and objectives.…
The Trial Master File, or TMF, is the compilation of essential documents that permits the evaluation of the conduct of a clinical trial and the quality of the data produced. It is structured to allow an independent reconstruction of the…
Regulatory documents form the official, auditable record of a clinical trial. They function as the detailed architectural plans and operational specifications for the study. Documents such as the protocol, Investigator's Brochure, and Informed Consent Form establish the scientific and ethical…
FDA 21 CFR Part 11 is the regulation that establishes the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten…
The ICH guidelines for clinical trials represent a harmonized international standard for the design, conduct, monitoring, recording, analysis, and reporting of clinical research involving human participants. This unified framework is intended to ensure that clinical data submitted to regulatory authorities,…
An informed consent form (ICF) template serves as a master document for generating all informed consent forms for a clinical trial program. It is a foundational document providing the required structure and pre-approved language to meet regulatory guidelines from bodies…
A statistical analysis plan template is a standardized, regulatory-aligned framework that details the specific methods for analyzing clinical trial data. It serves as a comprehensive blueprint for the analysis, ensuring all procedures are prospectively defined, objective, and reproducible. This technical…
A clinical study report (CSR) template serves as the standardized framework for authoring the comprehensive account of a clinical trial for regulatory authorities. This structured blueprint, designed in accordance with guidelines like ICH E3, ensures that all critical information is…
A clinical trial protocol is the detailed, formal plan for a research study. It is the single source of truth that defines the study's objectives, design, methodology, statistical considerations, and organizational structure. Its purpose is to ensure the safety of…