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Regulatory Medical Writing
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Document Types

Protocol & Protocol Amendments

  • Conceptualization of protocol
  • Well versed with SPIRIT Guidelines
  • Experience on working on varied protocol templates across different clients
  • Know-how and utilization of the Common Protocol Template – TransCelerate

Informed Consent Documents

  • ICF, Subjection information sheet, Assent and Audio-visual Consents
  • Ability to translate English ICD to regional languages

Clinical Study Report (CSR)

  • ICH E3 compliant Full, Abbreviated, and Synoptic CSRs
  • Sound Statistical understanding and interpretation for drafting results
  • Capable of authoring pharmacokinetic (PK) and pharmacodynamic (PD) results
  • Unique ‘Review Panel’ by medically qualified MW for CSR authoring
  • Lead Review Meetings/Comments Resolution meetings

Investigator’s Brochure

  • Authoring of Initial IB, IB Updates and IB Addendums
  • Alignment with DSURs with respect to CTFG guidelines

eCTD Modules

Well versed with QC of CO, SCS, SCE, SCP, ISS, ISE, Response Documents, Briefing Books, 120-day safety updates.

Authoring of Clinical Overview and Briefing Documents.

Dedicated Quality Control Group

Dedicated and expert Quality Control group capable of quality check for any and all types of Regulatory Medical Writing Documents.

U.S. trained Medical Writers.

Sole partner for Quality Control for TAs like Immunology and Virology for a sponsor.

Publishing

Collation of Appendices and relevant documents.

Submission ready checks including hyperlinking and formatting.

eCTD compliant documents like CSRs, IBs, Protocols.

Utilization of ISI Toolbox, TRS Toolbox, Acrobat ProDC, TRS Writer.

Therapeutic Areas experience across Phases 1 to 4