Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• A Successful Pre-IND Enabling Next Stage Of Development

  Confronted with challenges, unearth how after receiving regulatory consulting services, this biotech was able to evaluate deficiencies in its development program, augment leadership and technical expertise in its application review, and more.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• Success Factors For Launching Products With Orphan Drug Designation

  Orphan drug designation offers a number of financial incentives to pharmaceutical companies. Learn more about the potential hurdles of orphan drug development and the opportunities to maximize your success.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Optimizing End-To-End Processes To Reduce Costs And Improve Yields

  Explore the challenges faced by a large CDMO as well as the solutions that were provided to achieve significant time savings, cost savings, and the removal of a major downstream process limitation.

• GSK And Medable Discuss The Next Phase Of DCTs

  GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.

• 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.

• Digitalizing Batch Records In Pharmaceutical Production

  Pharma manufacturing embraces cutting-edge automation, yet outdated paper-based documentation hinders efficiency and delays batch releases. See how digital solutions can transform compliance.

• Case Study: Recruiting Pediatric Ultra-Rare Disease Patients

  Explore how Rezolute was able to overcome challenges while recruiting pediatric patients for a Congenital Hyperinsulinism (HI) clinical trial using a streamlined, single-source tool.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• Flexible Integrations To Reduce Risks And Increase Efficiencies

  Learn how a trial team kept the blind of central lab samples and patient treatment across a Phase III and extension trial, whilst optimizing the supply chain.

• Biotechnology Manufacturing Program Management

  Find out how a global biotechnology manufacturing company executing several interrelated projects achieved critical project objectives while adhering to schedule and financial commitments.