Medical Writing

1. Medical & Scientific

I. Clinical Trial & Drug Development Support

• End-to-End Clinical Trial Management: From Phase I-IV, including cell therapy (CAR-T) and complex global CVOTs.
• Clinical Pharmacology & PK Analysis: Pharmacokinetic modelling, statistical analysis with SAS for regulatory submissions.
• Real World Evidence (RWE): Global RWE program leadership, data integration platform implementation for launch excellence.
• Medical Affairs & KOL Engagement: Regional medical advising, KOL identification/profiling, and HCP engagement for therapeutic areas (Diabetes, Oncology, Cardiology).

Value Proposition & Impact

Accelerates drug development timelines through expert clinical oversight and data-driven insights. Bridges the gap between clinical data and market strategy with robust RWE and KOL engagement.

II. Scientific Communications & Publications

• Publication Planning & Execution: End-to-end publication support, developing manuscripts, abstracts, posters, and slide decks for peer-reviewed journals.
• Medical Information: Creation and delivery of medical information responses to HCPs, maintenance of Medical Response Documents (MRDs).
• Data Translation: Translating complex scientific data into accessible content for diverse audiences, including plain-language summaries for patients and MSL materials.
• Digital Health Content: Creation of medically accurate content for HCP digital platforms, online drug databases, and health education materials.

Value Proposition & Impact

Amplifies scientific impact through high-quality publications and clear communication. Enhances patient and HCP engagement with accurate, accessible medical information.

2. Regulatory

I. Clinical Trial Transparency & Disclosure

• Global Disclosure Leadership: Managing end-to-end clinical trial disclosure and transparency for ClinicalTrials.gov, EU CTR, and other global registries.
• Process Governance: Governing CRO performance, leading process improvements, and acting as Single Point of Contact (SPOC) for sponsors.
• Redaction & Data Anonymization: Expert redaction activities for EU CTR and other regulatory submissions to ensure compliance with privacy regulations.

Value Proposition & Impact

Ensures full regulatory compliance and public trust with transparent, accurate, and timely clinical trial disclosures. Mitigates risk through robust governance and process control.

II. Medical Devices (EU MDR & IVDR)

• Clinical Evaluation: Comprehensive authoring and review of Clinical Evaluation Reports (CERs, CEPs), and Clinical Study Reports (CSRs).
• Post-Market Surveillance: Management of Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF) plans/reports, and Periodic Safety Update Reports (PSURs).
• Regulatory Submissions: End-to-end support for regulatory submissions, including responding to Notified Body queries and ensuring compliance with EU MDR/IVDR.

Value Proposition & Impact

Facilitates successful market access and compliance for medical devices under the stringent EU MDR/IVDR frameworks. Provides a clear pathway for navigating complex regulatory landscapes.

III. Global Regulatory Affairs & Submissions

• Submission Dossier Management: Planning, publishing, and delivery of major global submissions (BLAs, NDAs, INDs, MAAs) in eCTD format.
• Regulatory Strategy & Intelligence: Development of regulatory strategies for new drug approvals (e.g., CDSCO in India), analysis of regulatory filings (FDA, EMA), and monitoring of regulatory news (MHRA, NICE, EMA).
• Labelling & Structured Content: Authoring and updating labelling documents (CDS, SmPC) and utilizing structured content management (SCM) for dossiers, CPPI, PIL, and Medication Guides.

Value Proposition & Impact

Navigates complex global regulatory pathways to achieve and maintain product approvals. Enhances submission efficiency through strategic planning, intelligence, and advanced authoring technologies.

3. Content Authoring

I. Clinical & Regulatory Document Authoring

• Core Clinical Documents: Authoring and quality control of Protocols, Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and Statistical Analysis Plans (SAPs).
• Safety & Aggregate Reports: Authoring and reviewing PSURs, PADERs, Risk Management Plans (RMPs), and Medical Information Reports (MIRs).
• Quality Management: Development and QC of Standard Operating Procedures (SOPs), training guides, and batch manufacturing records (BMR, PVP).

Value Proposition & Impact

Delivers high-quality, regulatory-compliant documents with scientific rigor. Streamlines document development processes through cross-functional collaboration and proven expertise.

II. Advanced Content Solutions

• AI-Enhanced Authoring: Validating and editing AI-generated content for clinical summaries, manuscripts, and regulatory news pieces to ensure accuracy and reliability.
• Literature Review & Synthesis: Conducting systematic literature reviews (DistillerSR, PubMed) for CERs, product claims, and scientific publications.
• Structured Content & Technology: Converting protocol content into machine-readable formats, standardizing content using SCM technology, and working within Veeva Vault and other EDMS.

Value Proposition & Impact

Drives efficiency and accuracy in content creation through cutting-edge technology and advanced methodologies. Reduces manual effort while maintaining the highest quality standards.