Medical Writing is an Integral Part of Clinical Research
Medical writing can assist you at any point in the drug development cycle regardless of the clinical trial phase. From protocol development to Clinical Study Reports, our medical writers work alongside IDDI statisticians to ensure accurate planning and reporting of results. Our medical writers can also help you by drafting and/or reviewing a registration dossier for FDA or EMA approval. Likewise, they may assist you with presentations at medical conferences and peer-reviewed publications in the medical literature.
IDDI uses its own writers or selects other expert medical writers who have experience in a wide array of documents and have the appropriate scientific background, knowledge of the therapeutic areas, and the skills to structure documents clearly and accurately while adhering to the appropriate ICH guidelines and related regulations.
Expertise in Medical Writing
- Protocol Writing:
IDDI provides the best clinical study design for your trial, and our medical writer will ensure that it is reflected in the protocol. We can work with clinicians and other investigators to provide a full protocol that meets ethical, scientific, regulatory and administrative requirements.
- Investigator Brochure (IB)
The medical writer will prepare IBs whenever needed.
- Clinical Study Report and appendices according to the ICH-E3 guideline “Structure and Content of Clinical Study Report”
Clinical trial data are presented with the biostatistical analysis and complete appendices in an integrated report, using either Sponsor’s standard template or IDDI’s template following ICH guidelines. At your convenience, the final integrated reports are delivered in PDF format or as hard copy.
From your raw clinical trial data, our medical writers produce a submission-ready manuscript that follows “instructions to authors” of the journal you have selected. After submission, we will also handle the corrections and the response to reviewers.
- eCTD for submission
When applying for a product license, our medical writing team helps you prepare the clinical parts of the Common Technical Document (CTD) submitted to regulatory authorities in the US, Europe, Japan and Canada.