WHITE PAPERS AND CASE STUDIES

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• EHR-To-EDC Success In A Complex, Adaptive Platform Trial

  I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

• 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.

• 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.

• How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives

  Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.

• From Paper To Digital Study Management In Large Patient Registries

  Uncover how this sponsor was able to independently design and oversee its clinical study, minimizing external assistance, and easing the workload for their sites through mobile app accessibility.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Unveiling The Critical Role of Sleep In Clinical Studies

  Explore the critical role of sleep in clinical trials and its impact on health outcomes, emphasizing the need to address sleep disturbances for more effective and reliable research.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Achieving Self Sufficiency In Data Collection For Optinose

  Uncover how this specialty pharmaceutical company was able to gain control over its EDC environment by adopting a solution their team could use in-house.

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• Operational Success By Strategic Investment

  Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.