Medical Writing at Ardent Clinical Research Services (ACRS)

Clear. Compliant. Scientifically Sound. At Ardent Clinical Research Services (ACRS), our Medical Writing team plays a crucial role in transforming complex scientific data into clear, accurate, and regulatory-compliant documents. With a strong focus on quality, compliance, and scientific integrity, we support pharmaceutical, biotech, and healthcare organizations throughout the clinical development lifecycle — from protocol development to regulatory submissions and scientific publications.

✍️Medical Writing Services

Our Medical Writing Capabilities

Comprehensive writing solutions covering every aspect of clinical development and regulatory submission

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Clinical Trial Documents

  • Clinical Study Protocols (Phase I to IV)
  • Investigator Brochures (IBs)
  • Informed Consent Forms (ICFs)
  • Case Report Form (CRF) guidelines
  • Protocol Amendments and Addenda
  • Tailored to meet ICH-GCP standards and regulatory expectations
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Regulatory Writing

Clinical Study Reports (CSRs) in ICH E3 format

Safety Narratives

Common Technical Document (CTD) Modules 2.5, 2.7

Investigator/Medical Expert Statements

Briefing Books, IND/NDA/ANDA/BLA Submission Packages

Responses to regulatory queries and deficiency letters

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Safety & Pharmacovigilance Writing

•Serious Adverse Event (SAE) Narratives
•Development Safety Update Reports (DSURs)
•Periodic Safety Update Reports (PSURs)
•Risk Management Plans (RMPs)
•Pregnancy reports and line listings
•Strict adherence to pharmacovigilance regulations
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Scientific & Publication Writing

  • Manuscripts for peer-reviewed journals
  • Abstracts, posters, and slide decks for conferences
  • White papers and technical dossiers
  • Product monographs and literature reviews
  • Scientific accuracy and ethical compliance
  • Target journal/conference formatting
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Medical Communications & Marketing

Medical Information FAQs and Response Letters

Product Training Materials

Patient Education Leaflets

Therapeutic Area Fact Sheets

Product brochures and newsletters

Support for medical affairs and commercial teams

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Our Expertise & Quality Standards

•Experienced writers with medical, pharmacy, and life sciences backgrounds
•Deep regulatory knowledge: ICH, GCP, global health authority requirements
•Rigorous internal QC and scientific/medical review
•Flexible delivery: project-based, FTE-based, or ongoing collaboration
•Therapeutic expertise across multiple disease areas
•Proven track record in IND/NDA/ANDA submissions

Why Sponsors Trust Ardent's Medical Writing Team

Proven track record in IND/NDA/ANDA submissions
Seamless collaboration with clinical, biostatistics, pharmacovigilance, and regulatory teams
Transparent communication, fast turnarounds, and high-quality deliverables
Confidentiality and data protection at every step
Therapeutic expertise: Oncology, gastroenterology, neurology, cardiology, infectious diseases, metabolic disorders