Clinical Supply Regulation Resources

  1. Creating Accurate, Efficient, And Effective CDMO Project Proposals 8/15/2023

    To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

  2. Decentralized Clinical Trials: A Win For Patients, Sponsors, & Investigators

    Learn how the integral role of Direct-to-Patient Services plays a part in the execution of decentralized trials and how sponsors can maximize these benefits to improve drug development.

  3. Analytics–Powered Approach To Patient Recruitment Strategy 7/15/2025

    In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

  4. Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP

    Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.

  5. Overcoming Obstacles To Deliver Critical Autologous Cell Therapy 3/25/2023

    See how teams ensured a seamless route, including on-time customs clearance and delivery of autologous cell therapy, from the U.S. to a manufacturing site in Germany

  6. Highly Potent, Perfectly Packaged 1/12/2023

    Experts explore a project to add a contained manufacturing facility and potent packaging suite by discussing the attention to technical detail required to exceed the required high standards and regulatory controls.

  7. Transforming The Pharma Supply Chain 7/17/2023

    Start leveraging logistics partners with global end-to-end solutions that can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.

  8. IMP Labeling: EU CTR Transition Considerations 6/26/2023

    Review current requirements as outlined by the EU Clinical Trial Regulation, supporting guidance, and three key considerations when planning IMP labeling activities for ongoing studies.

  9. What Does 2025 Hold For Pharma? 1/17/2025

    Look at what’s in store for pharma and life science in 2025. While we see many recurring themes, 2025 promises to be filled with unexpected — and possibly unprecedented — developments.

  10. Quality Assured: Bringing Life-Changing Therapies To Patients 1/12/2023

    Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.