• Home
  • Portfolio
  • Medical writing

Trusted partner for documenting the research results

Overview

The success of a clinical development programme depends on the proper documentation of research plans and results. We offer a range of flexible medical writing services to support various clinical study documentation needs. Our medical writers are trained and experienced in understanding the client expectations and designing protocols. Our writers’ with strong scientific background and therapeutic area-specific knowledge to ensures accurate and well-written submission-ready documents.

WHY ADVITY!

  • Flexible & broad experience in adapting client specific templates, style guides and tailored requirements
  • Our own templates (developed inline with the ICH requirements) in absence of a client template
  • Experienced project manager will coordinate with interdisciplinary team to ensure delivery of cohesive documents that meet rigorous scientific quality standards and are compliant with ICH, regulatory standards and client requirements
  • Broad experience in arranging study documents, ensuring documents are well-written, clear, and navigable, reducing review time and satisfying the expectations of the entire clinical research team
  • Highly qualified writers having broad experience with the whole spectrum of medical communications and regulatory documents, as well as an array of therapeutic areas

Our Services

1. Clinical study protocol development

  • Clinical Trial protocols (Phase I, II, III & IV)
  • PK & BA/BE studies (Both Healthy and Patient studies)
  • Pharmacokinetics & Pharmacodynamics (PK/PD)
  • Glucose Clamp studies

2. Trial related essential documents

  • Case report forms (CRF)
  • Informed Consent Documents (ICD)
  • Investigator brochure (IB)
  • Patient Information Sheets (PIS)
  • Patient diaries (PD)

3. Clinical & Non Clinical overview writing

  • Clinical overviews
  • Non Clinical Overviews

4. Safety aggregate reports

  • Periodic Adverse Drug Experiences Report (PADER)
  • Periodic Benefit Risk Evaluation Report (PBRER)
  • Periodical Safety Update Report (PSUR)
  • Drug Safety Update Reports DSUR
  • Risk Management Plan (RMPs)

ADVITY RESEARCH PRIVATE LIMITED

© 2022 ADVITY RESEARCH PRIVATE LIMITED, All Rights Reserved.
© 2022 Advity Research, All Rights Reserved.