Medical Writing Special Edition: The Force Behind the Speed – Medical Writing’s Role in Regulatory Submissions

Fast-Tracking the Writing of Master Protocols

By Mirela Niculita

• Addresses the growing need for efficient, adaptable trial designs.
• Examines challenges from the 2025 CTIS transition.
• Shares strategies for writing effective master protocols.

Flight Path to Success: How Project and Strategic Relationship Managers Accelerate Submissions

By Renatta Lavach-Savy and Kristen Brotzman

• Compares submissions to a flight, highlighting key support roles.
• Explains how managers keep timelines on track.
• Shows their impact on faster, smoother submissions.

Human-in-the-Loop

By Reema SelvaRaju

• Explores how AI and human expertise work together in medical writing.
• Stresses the importance of expert oversight for accuracy and compliance.
• Shows how Certara enhances quality without replacing human insight.

Advancing Paediatric Oncology Therapies: Challenges, Innovations, and Best Practices

By Ananth Kadambi, Justin Hay, SY Amy Cheung, Jacquelyn Binns, Roman Casciano, and Suzanne Minton

• Covers regulatory and clinical challenges in pediatric oncology.
• Highlights innovative strategies to speed therapy development.
• Shares ways to deliver impactful treatments faster.

Strategic Authoring in Clinical Study Reports

By Anaya Rehman and Honz Slipka

• Balances transparency with data protection in CSRs.
• Presents Certara’s SMART approach for compliance and AI-readiness.
• Aligns documents with evolving disclosure requirements.

EDD DPS: Expertise-Driven Document Planning & Support

By the Certara Team

• Matches expert writers to the right documents at the right time.
• Uses strategic planning to boost quality and scalability.
• Minimizes rework with early writing support.

Nightmares in Medical Writing: Maintaining Quality on Compressed Timelines

By Rose Pabelonia

• Shares lessons on managing tight deadlines without losing quality.
• Shows how teams stay focused under pressure.
• Provides tips for clarity, accuracy, and teamwork.

Planning and Preparing Regulatory Submissions Using Top-Down Messaging

By Mark Bowlby, Brenda Taylor, and Steve Sibley

• Introduces a messaging strategy to align submission documents.
• Uses the annotated USPI as a basis for cohesive communication.
• Helps teams reduce inconsistencies and streamline regulatory review.

Overcoming Challenges in Early Drug Development – Start with the End in Mind

• Highlights the importance of defining success early in development.
• Promotes alignment across scientific, regulatory, and operational teams.
• Seeks to reduce risk and enhance decision-making in early-phase programs.