Clinical Writing

Be Submission Ready With Our Clinical Writing Services

Our medical and clinical writing services offer support with accurate documentation across the clinical development process. Delivered by a dedicated medical writing team, we provide accurate, submission-ready documentation compliant with industry standards and requirements.

Our medical writing team has extensive experience in a wide range of clinical therapeutic areas covering phase I through phase IV of global clinical development, including:

  • Oncology
  • Gastrointestinal
  • Renal/Nephrology
  • Respiratory
  • Rheumatology
  • Cardiovascular
  • Pain
  • Infectious Diseases
  • Dermatology
  • Endocrinology

Our Medical Writing Solutions

The medical writing team work flexibly to your specific requirements, offering a range of bespoke technical writing solutions. From operating procedures, templates and style guides, we can support sponsors with the right documentation to proceed with clinical development.

Our medical and clinical writers offer appropriate guidance throughout your clinical journey, ensuring the process abides to appropriate industry and regulatory requirements.

Responsive clinical writing

We ensure timely delivery of documents and share our medical writing services closely with key operational departments including Project ManagementBiometrics, Medical Affairs, Clinical Operations, PharmacologyPharmacovigilanceRegulatory Affairs, and Quality Assurance to produce the highest quality documents.

All documents produced by our medical writing team undergo thorough reviews by the key operational departments and quality checks to ensure the highest standards.

Medical Writing

Our medical writing services cover a range of documents, with full support across the clinical development process. Our medical writing documents and services include:

Study reports

  • ICH GCP compliant Clinical Study Reports (CSRs) Phases I to IV.
  • CSR synopses for public disclosure.
  • Rewriting or amalgamation of existing CSRs and electronic Common Technical Document (eCTD) formatting of CSRs.
  • Development Safety Update Reports (DSURs).
  • Patient Safety Narratives (for CSR inclusion).

Other documents

  • Study protocols, amendments, and administrative changes.
  • Investigator Brochures (IBs).
  • Investigational Medicinal Product Dossiers (IMPDs).
  • Standalone quality checks.

Get medical writing from industry experts

We are always happy to discuss our medical writing services with clients, please do not hesitate to contact us.

What our
Clients Say About Us

The people working at Simbec Orion are dedicated, very professional and they cover all aspects of clinical research. A team will be set up for your project, who will have a strong focus on your study in a very open minded and friendly atmosphere. The studies I have outsourced to Simbec Orion, have been successfully managed and performed. I will use Simbec Orion in the future and I can strongly recommend them to other pharmaceutical companies.

Tina Lidén Mascher, Head of Clinical Operations

Klaria AB

Got a question?
Get in Touch or Submit an RFI/RFP

Our team is on hand to answer any questions you might have relating to the work we do at Simbec-Orion. Just fill in the form below, making sure to tick the boxes that apply, and we’ll respond as quickly as we can.

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