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.
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.
Staff Publications and Presentations:
- DIA Forum Presentation 2013: Structured Authoring: Driving Improved Efficiency, Quality, and Costs. Kristina Brannstrom.
- Regulatory Affairs Professionals Society (RAPS) Conference Panel Discussion 2011: eCTD Compliance and Regulatory Review of Clinical Study Reports. Panel Lead: Kristina Brannstrom, Participants: Theresa Kehoe (FDA) and Beth Ann Garni-Wagner (pharma company).
- AMWA Poster Presentation 2009: Clinical Study Reports: Efficiencies and Impact on Timelines. Kristina Brannstrom and Janet Zucker.
- AMWA Presentation 2008: Implementation of a New Process for Patient Narrative Generation. Tess Gilbert (pharma company) and Janet Zucker.
- AMWA Journal Vol. 20, No. 2: 2005 (75-76): Successful Outsourcing in Medical Communications. Cynthia Hooper (pharma company) and Janet Zucker.
- AMWA Presentation 2004: How to Create and Ensure a Successful Outsourcing Program in Medical Writing. Cynthia Hooper (pharma company) and Janet Zucker.
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 over 15 million pages.Published and prepared over 500 electronic submissions.
- Published and prepared over 1200 eCTD submissions.
- Prepared over 4500 maintenance/lifecycle submissions.
- 100% of our documents have passed technical validation.
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.