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WHITE PAPERS AND CASE STUDIES

• Top Therapeutic Areas In The Asia Pacific Clinical Trial Landscape

  Explore why the Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions as trial locations

• Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A Deadline

  Go inside a successful manufacturing transfer of over 140 Class-III silicone medical devices and on-time delivery for a top-30 OEM through expert project management and rigorous validation processes.

• Fortrea Optimizes Site Matching On Retina Clinical Trials

  Faced with challenges in engaging clinical trial sites within the retina research landscape, Fortrea sought a partnership that leverages RWD to streamline site feasibility assessments.

• Improving Patient Health And Safety

  Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

• Top-Tier University Stays Compliant With HRPP Assessment

  Discover how one university was able to identify and resolve programmatic gaps in compliance with federal regulations and revitalize its Human Research Protection Program.

• Evansville Water & Sewer Utility: 4 Tactics For Managing & Organizing Vertical Assets

  EWSU, serving 65,000 customers, revamped its vertical asset tracking with POWER Engineers to enhance maintenance workflows. Here's how they optimized their processes.

• Medical Writing Support Relieves A Burdensome Review

  Unearth how medical writing and project management teams were able to streamline the development and review of a critical marketing application document.

• How To Manage A Drug Product In A Medical Device Environment

  Discover how ProPharma successfully ensured GMP and GDP compliance for a drug product within a medical device environment.

• Performance Of Protein A Resins For Different mAbs

  Review a Protein A resin solution assisting biotech companies who are working with and removing impurities from a wide variety of antibodies.

• Expert Consulting, MRCT Strategy Rescues Oncology Program

  Uncover how teams identified missing IB data and necessary additional details needed to outline U.S. study challenges as required for local authority approval in a previously failing study.

• How To Facilitate Good Clinical Data Review In Your Clinical Trial

  Learn how to create a system based on connectivity and automation, aggregated and usable data, flexible analysis, and methods of collaborative data review by centralizing analysis and communications.

• Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study

  Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.