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Medical and Scientific Writing

Reliable documentation is at the heart of successful clinical research ensuring clarity, precision, and compliance at every step.

 

From protocol development to final study reports, we transform complex information into clear and simple documents and materials.

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Our team of Medical Writers and Medical Monitors collaborates cross-functionally with Biostatisticians and Project Managers to develop effective engagement tools for patients, reports for regulatory authorities and publications for the scientific community.

Whether you need regulatory documents and reports, scientific publications, or educational materials, our services can be integrated into a full-service contract or provided as à la carte solutions tailored to your specific needs.

We provide comprehensive support in developing and managing critical clinical trial documents, ensuring compliance, clarity, and regulatory readiness:

  • Clinical study protocols & investigation plans
  • Investigator Brochures (IB)
  • Informed Consent Forms (ICF)
  • Charters for the Data Safety Monitoring Board (DSMB)
  • Charters for the Clinical Endpoint Committee (CEC)
  • Investigational Medicinal Product Dossiers (IMPD)
  • Investigational Medicinal Product Information (IMPI)
  • Medical & safety management plans

We ensure compliance and regulatory readiness with expertly prepared safety and submission reports, supporting global drug development and approval processes:

  • Safety case report (i.e. case narrative, CIOMS, MedWatch Form)
  • Developmental Safety Update Report (DSUR) / Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Report (PBRER)
  • Clinical Study Report (CSR)

We provide comprehensive assistance in developing high-quality scientific publications to effectively communicate research findings and clinical trial results:

  • Scientific articles
  • Manuscripts
  • Research papers
  • Abstracts
  • Posters
  • Presentations

We create engaging, informative, and compliant materials to support study awareness, patient education, and professional development, including:

  • Study participant educational materials
  • Study landing page
  • Informational brochure
  • Advertisements
  • Continuing medical education materials

Interested in this service?
Let’s work together!

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