Global life sciences R&D spend is drastically outpacing revenue growth. Trial protocol complexity is spiking across endpoint requirements, eligibility criteria, and geographic scale. Revenue opportunity is tightening as generics capture nearly 80% of the prescription market, and teams are increasingly siloed — despite being more interdependent than ever before.

The road is narrow. But HighPoint’s research and development team shows life sciences clients the way forward.

Based on our extensive experience, we have formulated new best practices that span clinical development and regulatory information management. We know how to make processes, people, data, and technology work more efficiently, helping our clients to control costs and get products faster to market so they can focus on meeting their strategic goals.

CLINICAL DEVELOPMENT

REGULATORY INFORMATION MANAGEMENT (RIM)

IDENTIFICATION OF MEDICINAL PRODUCTS (IDMP)

Additional Resources

Meet the challenges posed by IDMP with insight from HighPoint. Our strategies prepare pharmaceutical clients for compliance today, while giving them the flexibility to adjust project plans when changes occur.

Leading Research & Development

  • Stuart Pyle

    Practice Leader

    Stuart Pyle

    Stuart is an industry leader and advisor with over 25 years of industry and consulting experience in the life sciences, medical device and healthcare industries. His primary focus over his career has been in R&D operating models, e-clinical-digital R&D, process reengineering, big-data-analytics-standards, platform-systems integration and business outsourcing.

    Stuart has extensive practice, project leadership and operational experience in leading R&D strategies, roadmaps, implementations, change management for cross functional initiatives in delivering critical business capabilities in Clinical Development, Operations, Data Management and Decision Sciences. In addition, he serves as a member of the Big-data Advisory Board at Rutgers University.

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  • Jens-Olaf Vanggaard

    Director, Research & Development

    Jens-Olaf Vanggaard

    Mr. Vanggaard is a strong team player and a results-driven senior Life Sciences R&D consultant with 9+ years of experience within Clinical Development and Regulatory Affairs implementing Clinical Data Warehouses, Meta Data Repositories, Clinical Trial Management Systems, Electronic Trial Master Files and helping more than 5 clients prepare for IDMP implementation. In addition, Mr. Vanggaard a member of the EU IDMP Task Force Referentials sub-group and is working closely with key colleagues to develop the HPS FRED IDMP solution for manual data collection and maintenance as well as an MDM-based IDMP accelerator leveraging one of the leading MDM and data management platforms on the market.

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