WHITE PAPERS AND CASE STUDIES

• Expert Consulting And MRCT Strategy Rescues Oncology Program

  Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.

• Sustainable Solutions For Medical Devices

  Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• What Is ICH GCP, And How Does It Impact Clinical Planning?

  The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• 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.

• Aseptic Process Design And Simulation Under Annex 1 Guidelines

  Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• A Paperless Lab Simplifies, Accelerates Full Sample Lifecycle Data Management

  Implementing IDBS’ ELN helped Crown Bioscience realize electronic experimental records, optimizing our business processes and helping them to be more standardized.

• Automated Evidence Generation For Regulatory-Grade RWD

  Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.

• How Syneos Health Tackles Protocol Complexities

  Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase IIV clinical trials, particularly under a complex adaptive trial protocol.

• Economic Advantage Of Robotic Gloveless Pharmaceutical Isolators

  Are robotic gloveless isolators the key to smarter, safer, scalable solutions? Discover how they can revolutionize aseptic filling by reducing contamination, minimizing waste, and enhancing manufacturing flexibility.