Our meticulous approach to medical writing creates impactful documents that facilitate effective communication and support regulatory compliance.
With a well-written regulatory document throughout all stages of the drug development process, give your regulatory submission the best chance for approval.
An integral part of clinical research is Medical Writing, and our team of specialist medical writers deliver accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards. Our team of medical writers becomes an extension of your team by being responsive and flexible to your needs, using our expertise to transform your complex and diverse data into an accurate and evidence-based account of the clinical profile of your drug in relation to treatment and patient safety. Our team from the pharmaceutical industry, clinical research organizations, and academia has a wide breadth of knowledge and experience.
The meticulous documentation produced by EPDA is through scientific, statistical, editorial and quality control review.
Clinical Study Reports (CSRs): We specialize in crafting comprehensive and accurate CSRs, which are essential documents summarizing the entire clinical trial process, including study design, methodology, results, and statistical analyses. CSRs play a crucial role in presenting the study findings to regulatory authorities.
Protocols: serve as a blueprint for conducting the study and ensure consistency in data collection and analysis.
Case Report Forms (CRFs):Our CRFs ensure accurate and consistent data collection, facilitating data analysis and interpretation.
Manuscripts and Publications:We support the publication process by providing medical writing services for manuscripts, abstracts, posters, and presentations.
