Document Migration

WHITE PAPERS AND CASE STUDIES

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• 4 Key FSP Considerations To Optimize Drug Development

  Review several benefits of using a functional service provider model and what four things to consider before choosing a partner to help meet challenging drug development timelines.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• Accelerate Drug Development With Master Protocols

  Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• From Phase I In Australia To A Global Phase III

  With some help, see how one California-based biotech company was able to get its patients on treatment by the end of the fiscal year and identify additional opportunities to streamline processes and leverage document/process standards.

• Patient Insights Informed Consent Engagement

  By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.

• Insights And Effective Strategies For A Successful Technology Transfer

  Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• Study Start-Up Challenges: Hard Realities, Effective Strategies

  Launching a study is complex, and the time between protocol approval and the first patient visit has increased dramatically. How can companies reverse this trend and accelerate study start-ups?

• Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration

  A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

• Creating A Sustainable Business Model For Cell And Gene Therapies

  Avoid product launch delays and expand patient access to CGTs by understanding and meeting regulatory guidelines and securing approval for reimbursement of treatment costs.