SERVICE OVERVIEW MEDICAL WRITING

Taking your new drug to market requires concise, well-written, scientifically and medically accurate documentation at all stages of its clinical development.

At Nuvisan we have an expert team of medical writers who understand the importance of keeping your project on-time and on-budget, and are able to adapt to the changes in timelines and scope of work that occur in clinical research. Our writers come from medical and life sciences background and are all M.D., Ph.D and Master’s level qualified, and have substantial experience in writing in accordance with regulatory requirements at all stages of a clinical product’s lifecycle.

Nuvisan’s medical writers work closely with our Medical Affairs, Clinical Operations, Biostatistics, and Quality Assurance departments to ensure that your documents are prepared to the highest quality standards, while maintaining clarity and accuracy. Whether you require documents as part of an integrated clinical research package with Nuvisan or as a standalone service, our medical writers can apply their expertise and commitment to the full range of materials at all phases of development:

• Phase I-IV protocols

• Phase I-IV clinical statistical reports

• Investigator brochures

• CTD modules

• Manuscripts

• Abstracts and posters

• Medication guides and patient information leaflets (PILs)

• Periodic safety reporting

• Patient safety narratives

Our documents are written to be fully compliant with all applicable ICH guidelines, whether your own templates and style guides are used, or ours. Nuvisan’s medical writers follow global standard operating procedures and, guided our Quality Assurance team, all documents are subject to rigorous quality control.

With extensive experience and high quality standards, Nuvisan’s medical writing team make sure that your documents exceed expectations.

Contact

Business Development
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Dr. Sylvie Bruchmann
Vice President

James Dickinson
Global Head 
of Clinical Services

Dr. Dirk Lehnick
Head of Data Science

Dr. Florian Schwaak
Director 
Business Development