Medical Writing

Capabilities and Experience:

Advanced Clinical has significant Medical Writing expertise within a few therapeutic areas such as Pain, Osteoarthritis, Diabetes, and Insomnia. However, we have worked more broadly, with our involvement in 20+ development programs across multiple therapeutic areas. Our capabilities support the end-to-end needs of a clinical trial. We provide consulting, expert advisory services and board monitoring/management/support:

Results:

We’ve had significant results across every therapeutic area, which includes 30+ products and two “blockbusters”:

Tokyo-based $15B Pharmaceutical Company:

• Hired, trained, and supervised 30-employee transatlantic medical writing department to prepare U.S./European regulatory documents for 30+ products
•  Spearheaded development of templates, editorial standards, processes, and infrastructure
•  Established EDC capability for e-Submissions
•  Led 20-member cross-functional team to define timelines, dependencies, and responsibilities for preparation of initial client NDA in CTD format
•  Co-led 15-member cross-functional international team that developed global templates and processes for clinical study reports, protocols, and Investigators’ Brochures
•  Organized 6-member team (including a direct-report Manager) in London to provide in-house medical writing for European office
• Participated in 10-member team to implement global electronic document management system, enabling electronic submissions to FDA in advance of current requirements
• Results:
  
  • 100 percent compliance with FDA standards
  • 300+ timely regulatory submissions
  • 20+ successful development program launches
  • Significant supplementary approvals for blockbuster drug in U.S. and Europe

U.S.-based $50B Pharmaceutical Company:

• Managed therapeutic area writing activities
• Authored 100+ regulatory submission documents, including: 16 major summary documents, responses to MAA regulatory questions, white papers, Phase I-IV clinical study reports, manuscripts for publication, investigator’s brochures, and briefing documents
• Results:
  • Six applications in the U.S., Europe and Australia/New Zealand
  • Successful sNDA for blockbuster drug

U.S.-based $31B Pharmaceutical Company:

• Prepared original manuscripts, review articles, symposia presentations, and regulatory documents. A few key deliverables: six manuscripts published in peer-reviewed journals, one IND
• Prepared training materials for pharmaceutical sales teams
• Results: Significant post-sNDA support for two blockbuster drugs

Deliverables:

Using our capabilities, we lead teams in creating Medical Writing deliverables from the “target” phase to “post-NDA.”

Differentiators:

Advanced Clinical has innovated both the science and art of traditional Medical Writing. Through our innovative approach, we offer a dynamic team to match client needs; integrated, end-to-end information management; strategically aligned and best-in-class practices; and fused people, process and technology to ensure fully integrated implementation of each project.