MEDICAL WRITING & PUBLICATION

Saliegral started as a core medical writing company before expanding into a full biometrics solutions provider and we pride ourselves on the 100% retention rate of our clients in this space. One of our founder members has worked with global CROs and Pharma for over 18 years and her passion and experience reflect on every document we produce for our client. We have delivered >200 clinical documents covering study protocols, Informed Consent Form/Ascent Forms, Investigator’s Brochure, Clinical Study Reports, and manuscripts/posters, among others.

We are flexible enough to work on your templates or you can choose to pick our tools & templates for your medical writing needs. Our team offers coverage to an extensive therapeutic area spanning oncology, central nervous system, urology, cardiovascular, infectious diseases (including COVID-19), general medicine, respiratory, dermatology, vaccines, endocrinology, and medical device & diagnostic, among others.

Our solution includes the development of core clinical regulatory documents including publishing,  safety reporting documents writing, and medical communications and evidence generations.

We cover

Clinical Regulatory Documents & Publication

  • Clinical Protocol/Clinical Investigation Plan
  • Informed Consent Form/Ascent Forms & Lay Person Summaries
  • Investigator’s Brochure (IB)
  • Clinical Study Reports (CSR)
  • Clinical Evaluation Reports (CER)
  • Clinical Trials Publication Manuscripts and Posters
  • New Drug Application (NDA)
  • Investigation Medicinal Product Dossier (IMPD)
  • Orphan Drug Designation (ODD) application
  • eCTD Modules 2.5 and 2.7
  • Preclinical Study Reports
  • Abbreviated Clinical Study Reports or Synopsis
  • Summary of Product Characteristics
  • Protocol Slide Kits & Investigator Training Material
  • Patient-reported Outcome Document – Patient Diaries etc.
  • Clinical Trial Disclosures

Medical and Scientific Communications & Evidence Generation

  • Systematic Literature Reviews a
  • Meta-Analyses
  • Congress Slides
  • Posters/Manuscripts
  • Product Literature/Monograph
  • Patient Education Materials
  • Disease Management Booklet

Safety Reporting Writing

  • Patient Safety Narratives
  • Development Safety Update Reports (DSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRER)
  • Periodic Safety Update Reports (PSUR)
  • Periodic Adverse Drug Experience Reports (PADER)
  • IND annual safety reports

We also offer standalone Medical Editing, Quality Control Review across clinical regulatory suites of documents. In addition, we provide Document Redaction solutions, to support all your data transparency and anonymization needs. We have our proprietary editing and authoring tools that we deploy across our medical writing documents.