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Medical & Scientific Writing

Bridging Knowledge & Clarity

Lambda Therapeutic Research provides fully integrated Medical Writing Solutions with expertise in diverse therapeutic areas including vaccines and devices. Our dedicated team collaborates closely with biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and compliant documents.

Regulatory Medical Writing

Start-up Phase:
  • Investigator's Brochure (IB)
  • Protocols and ICDs
Conduct Phase:
  • Pre-Database Lock (DBL) Narratives
  • Shell Clinical Study Report (CSR) with mock tables
Closure Phase:
  • Post-Database Lock (DBL) Narratives
  • CSR with appendices
Post-Study Phase:
  • eCTD Modules
  • Summary/Health Authority (HA) Documents

Drug Safety and Risk Management Reporting

Aggregate Reports

 DSUR / PBRER / PSUR / PADER / SUSAR LL

Risk Management Plans

 EU / Core

Medical & Scientific Writing Support for Diverse Document Types:

Regulatory Documents

  • PIP part F and part A
  • PIP Key Elements Form
  • Nonclinical/CMC documents
  • Orphan Drug Annual Report
  • Actual Orphan Drug Application
  • Original Pediatric Written Request (FDA)
  • PIP Scientific Document (parts B-E, includes waiver)
  • Orphan Drug supporting Briefing Books (BB) and updates
  • Module 2.4, 2.5, 2.6 & 2.7 (Clinical & Non-clinical summaries)
  • Proposed Pediatric Study Request/Pediatric Study Plan (PPSR/PSP) + modifications
  • Correspondence with Health Authorities and Cover Letters including Meeting requests.
  • Scientific Advice Document/Documents for EU Scientific Meetings and other ROW HA meetings
  • Clinical Overview (CO) to support global submissions, (c)MAA, (s)BLA/(s)NDA, Type II variations, etc.
  • PIP Update (request for PIP modification), including final consolidation of comments after HA approval

  • DSMB charter
  • Statistical Analysis Plan
  • Protocol Registration Forms
  • Protocols for epidemiology studies
  • Protocol Clarification Communication
  • List of anticipated events in protocols
  • Informed Consent Form (including Master ICF)
  • Clinical Study Protocols for Phase 0, I to IV studies
  • Amendments/Revisions for Clinical Study Protocols
  • Protocol Synopsis / Protocol design / Protocol Outline
  • Responses to Ethics Committees and Regulatory Agencies

  • PK Reports
  • Modeling Reports
  • CSR Appendices
  • Clinical Subject Narratives
  • DMC/DSMB Report Package
  • CSRs for Epidemiology studies
  • CSR Addendum/Erratum/Synopsis
  • PRCI (Public Release of Clinical Information) Health Canada
  • CSR body (full, abbreviated, synoptic) for Phase 0, I-IV studies

  • Writing of product information
  • Writing of any PK data summary
  • Writing of clinical data summary
  • Writing of nonclinical sections of IB
  • Writing of reference safety information (co-ordination only)
  • IB + IB updates (clinical sections + other contributions: PK, safety, PV, CMC) + coordination of finalization

Drug Safety and Risk Management Document Types

  • RMP Annex 1
  • NDA Annual Report
  • Health Hazard Evaluations
  • REMS and REMS assessment reports
  • PBRER/PSUR and Responses to HA queries
  • Core RMP – development and updates, DSUR
  • Post-marketing Commitment Safety Assessment Reports
  • Responses to PRAC Assessment Reports of PBRERs
  • IND Annual Report (US regional appendices of the DSUR)
  • EU Risk Management Plan (RMP) – development and updates
  • Ad hoc reports on safety issues (e.g., trend analyses, risk assessment reports)
  • SUSAR LL Brief Report (coordination, case selection, content input as needed)
  • Addenda to the Clinical Overview (ACOs) – part of periodic safety reporting obligations

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