Medical Writing

Whatever the Medical Writing and Document Publishing demands, Quintiles delivers the quality and timeliness required to ensure a project stays on track.

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15 million pages published and over 500 electronic submissions prepared

The success of a clinical development program depends on the proper documentation of research plans and results. Quintiles offers a range of flexible Medical Writing and Document Publishing solutions to support various clinical study documentation needs.

Medical Writing

Our team of more than 70 writers have experience working in a broad range of indications and therapeutic areas. Located on five continents, Quintiles Global Medical Writing offers flexible solutions for single documents or an entire multi-study program.

Our Medical Writers can assist at any point in the product development lifecycle across Phase I to Phase IV, and have experience in a wide array of documents, including clinical study protocol development, Investigator Brochures, clinical study reports, patient narratives, DSMB updates, regulatory submissions and other documents involving study data. Our Medical Writing services follow ICH guidelines and are compatible with similar regulatory requirements.

Document Publishing

The Document Publishing team averages 15+ years plus experience and many are certified in several software applications used for electronic Publishing.

Experience You Can Trust:

  • Published and prepared over 700 non-eCTD electronic submissions and 1900+ eCTD submissions to the EU, US and Canada.
  • 100% of documents passing technical validation.
  • 65+ INDs and over 17 million pages published between 1999 and 2015.
  • Over 5000 maintenance/lifecycle submissions prepared between 1999 and 2015.

Document and Submission Types:

  • NDA, MAA, NDS, PMA, 510(k) (Initial and all forms of lifecycle).
  • IND, IMPD, IDE (initial and all forms of lifecycle).
  • Clinical study protocols and reports.
  • Clinical study report appendices.
  • Case report forms.
  • Define/CRT documents.
  • Investigator Brochures.Briefing/meeting packages.

Publishing services can be full publishing or submission-ready, as best meets the Sponsor’s needs. This allows the maximum flexibility and efficiency for the Sponsor. Quintiles can perform full publishing or submission-ready publishing as outlined below:

  • Full publishing: Fully compliant electronic or paper deliverable ready to submit to Health Authority.
  • Submission ready: Fully compliant electronic document preparation ready for Sponsor to complete full publishing for submission to Health Authority. 

The power of possibilities

Expertise in medical writing for clinical research.

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