Clinical Supply Regulation Resources

1. 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.

2. 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.

3. Clinical Manufacturing: What It Is And How It Works 2/27/2022

   Clinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?

4. Controlled Substances In Clinical Trials 3/30/2023

   Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.

5. Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials 5/12/2023

   Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.

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. Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change 3/9/2023

   A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.

8. Optimized Laboratory Kitting Is Key To Successful Clinical Trials 5/18/2022

   Clinical trials can be completely derailed by the absence of a single component, a lack of clarity in labelling, or errors in temperature-controlled logistics.

9. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

   Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

10. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

    Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.