Medical Writing to Cover All Narratives

Medical Writing to Cover All Narratives

Well-structured information to expedite submissions and approvals

Bringing new drugs to market requires thousands of pages of documentation to accurately capture timely clinical trial information. Mistakes can result in lost time and money and significantly set back development.

At Synteract, we strive to deliver actionable results to address your clinical trial needs. Our medical writing group consists of qualified PhDs and other experts, and our European medical writers are all members of the European Medical Writers Association. Our team includes native speakers with years of experience translating all documents necessary for the performance of clinical studies. They are guided by global standard operating procedures and work closely with physicians, biostatisticians, pharmacokinetics and regulatory specialists. Our quality review team continuously ensures the highest standards and compliance with style guides and regulatory guidelines.

Medical Writing Expertise at Synteract

Whether it’s a first clinical protocol, a pivotal trial protocol, or associated documents such as the ICF, the investigator’s brochure, or a full IND/IDE, Synteract’s team brings the therapeutic, clinical, regulatory, and writing expertise needed to ensure quality documentation for the success of your clinical trial from design phase to final regulatory submission.

From creation of documents to electronic document production and regulatory publishing--we offer robust, reliable medical writing support to expedite submissions and approvals. Our medical writing services are offered as an integrated part of our clinical development expertise or as a standalone service with each strategy tailored to address client needs. With the high volume of documents required in clinical trials, we often offer medical writing through a Functional Service Alliance (FSA), with a dedicated team to assess report deliverables and create messaging efficiencies. We leverage innovative technologies and work with customers to determine optimum communication pathways to keep them informed every step of the way.

Synteract Medical Writing Services Include:


  • Phase I-IV protocol/informed consent development
  • Phase I-IV integrated clinical statistics reports
  • Investigator's brochure development
  • SOP development
  • IMP dossiers
  • Clinical study reports according to ICH E3 and eCTD format
  • Clinical study protocols and amendments 
  • Subject information sheets and consent forms, including local language ICFs (prepared and reviewed by the relevant country) 
  • Abstracts, manuscripts, and posters 
  • Regulatory applications and submissions 
  • Case narratives  
  • Scientific publications for peer-reviewed journals 
  • Preparation and submission of NDA/sNDA, MAA, PMA, 510(k) and CTD technical summaries
  • IND summary sections and special reports
  • Pre- and post-approval aggregate safety reports
  • Serious adverse event narratives
  • Human pharmacokinetics and bioavailability
  • Translations of regulatory documents

“Medical writing underpins all facets of drug development as it is necessary at every phase. That’s why ensuring you have the best possible team working on your documents is essential.”

Tony Womack, VP Medical Writing, Synteract

Contact us today to find out how our medical writing expertise can help you.

x

Submit RFI / RFP

..
By submitting your information to us through this webform, your business details will be added to our database. In accordance with our Privacy Notice, we may then contact you with marketing information about Synteract that might be of interest to you. We will never sell your details to third parties. You can unsubscribe from marketing communications at any time.

Required

x

Contact Synteract

Tell us how to stay in touch with you:

By submitting your information to us through this webform, your business details will be added to our database. In accordance with our Privacy Notice, we may then contact you with marketing information about Synteract that might be of interest to you. We will never sell your details to third parties. You can unsubscribe from marketing communications at any time.

Required

x

Download Resource

By submitting your information to us through this webform, your business details will be added to our database. In accordance with our Privacy Notice, we may then contact you with marketing information about Synteract that might be of interest to you. We will never sell your details to third parties. You can unsubscribe from marketing communications at any time.

*Required