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 R&D 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

With more than ten years of comprehensive knowledge and experience, HighPoint’s R&D team can guide clients through every step of clinical development — from trial planning to close-out.

  • Drug development technology assessments
  • Drug development IT strategy and roadmap
  • Clinical trial management, risk-based monitoring, and electronic trial master files
  • Clinical data management, statistical computing, and clinical data warehousing
  • Clinical data reporting and analytics
  • Clinical data standards management
  • Clinical trial protocol design and cost benchmarking
  • Content management and collaboration
  • IT project services, project management requirements, vendor selection, validation, and integrations
  • Technology partners: Informatica, Medidata, SalesForce, Veeva

Clinical Design Memory White Paper

08-14-2018
Successful companies capture and build on insights from their past trials with design memory tools. Learn how they work.
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REGULATORY INFORMATION MANAGEMENT (RIM)

Regulatory and technological factors are changing the face of the regulatory information management landscape. EMA, SPOR, and CESSP requirements, advances in AI, and new global standards including ISO IDMP and iCH eCTD 4.0 are just some of the factors impacting RIM.

With a thorough assessment of where you stand today, your ideal future state, and the roadmap to get there, HighPoint can help you understand and meet your full improvement potential, while moving your organization to an end-to-end solution.

We have developed a comprehensive RIM framework and methodology to help clients find and close regulatory information gaps, as well as unmet improvement potentials.

  • RIM assessments
  • RIM strategy and roadmap
  • Regulatory data governance, standards, and master data management
  • Product and registration lifecycle management
  • Content and submission management
  • Regulatory reporting and analytics
  • IT project services
  • Technology partners: Amplexor, Informatica, Veeva

IDENTIFICATION OF MEDICAL PRODUCTS (IDMP)

For more than three years, HighPoint’s R&D team has been intensively involved with IDMP from ISO IDMP ballots, the SPOR Task Force, and numerous client projects. Drawing on this experience, we offer a comprehensive set of IDMP services from initial assessment and strategy development through systems implementation and integration, data migration, and managed services.

  • IDMP assessment and roadmap
  • IDMP data governance
  • IDMP solution definition and selection
  • IDMP business case
  • IDMP technology proof of concepts
  • IDMP data stewardship
  • IT project services
  • Technology partners: Amplexor, Informatica, Veeva

IDMP: An Opportunity for RIM Improvement Webinar

08-14-2018
Is your organization on the right track for compliance readiness? Watch our webinar and start aligning to best practices today.
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ADDITIONAL RESOURCES

Case Study: Clinical Design Memory White Paper
READ PAPER
Webinar: HighPoint R&D Webinar
VIEW WEBINAR
Webinar: HighPoint IDMP Webinar
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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.

  • 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.