Medical Writing

EXCEPTIONAL MEDICAL WRITING SERVICES AT ESTERN Medical CRO Life Sciences

Medical Writing is a fundamental and well-established function at ESTERN Medical, seamlessly integrated into the fabric of R&D clinical writing, medical monitoring, pharmacovigilance, and biostatistics. Our dedicated medical writing team, comprised of experienced professionals, ensures the creation of scientifically sound and clinically acceptable documents that convey our Sponsor’s key messages effectively.

Key Highlights of ESTERN Medical’s Medical Writing Services:

1. Integrated Approach: The medical writing team collaborates closely with senior research clinicians, statisticians, and lab scientists to ensure the accuracy, scientific validity, and clinical acceptability of the documents.
2. Comprehensive Coverage: Our medical writing team handles a wide range of clinical projects related to the development of pharmaceuticals, biologics, and medical devices. The team possesses expertise in dealing with complex medical research topics.
3. Quality Assurance: All documents undergo a rigorous quality assurance review before being delivered to clients for review. This process ensures the highest standards of accuracy, clarity, and compliance.

Medical Writing Projects at ESTERN Medical:

1. Clinical Study Reports: Comprehensive reports detailing the results of clinical trials.
2. Protocols (INDs, NDAs, PMAs, 510Ks, IDEs): Detailed documents outlining the objectives, design, methodology, and statistical considerations of clinical trials.
3. Investigator’s Brochures: Documents providing essential information on the investigational product and its use in clinical trials.
4. Nonclinical Study Summaries: Summaries of nonclinical studies conducted as part of the drug development process.
5. Briefing Documents: Documents prepared for regulatory interactions, providing essential information to regulatory authorities.
6. Informed Consent Documents: Documents outlining the information provided to participants in a clinical trial to help them make an informed decision.
7. Adult & Pediatric Assent Forms: Forms outlining the agreement of individuals not able to give full legal consent.
8. Annual Reports: Comprehensive reports summarizing the progress of a clinical trial over the past year.
9. Periodic Safety Update Reports (PSURs): Reports providing an update on the safety profile of a medicinal product.
10. Integrated Summaries of Safety and Efficacy (ISS/ISEs): Summaries combining safety and efficacy data for regulatory submissions.
11. Literature Reviews: Comprehensive reviews of relevant scientific literature on a particular topic.
12. Abstracts/Presentations: Summaries of research studies or findings for presentation at conferences or publications.
13. White Papers/Journal Articles: In-depth documents presenting research findings, analyses, or perspectives on a specific topic.

ESTERN Medical’s commitment to excellence in medical writing ensures that our clients receive documents that meet the highest standards of regulatory compliance, scientific rigor, and communication effectiveness.