ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• 5 Ways To Get Ready For IRT Regulatory Inspections

  Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

• Navigating Audit Trail Data Regulations And Accessibility Changes

  Data is the single most important thing in a clinical trial. Leverage the power of clinical trial data with effective utilization and access in a changing regulatory landscape.

• Developing Injectable Drug Placebo Formulations For Clinical Trials

  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.

• What To Look For In Your IRT/RTSM Solution For A Simpler Trial Execution

  Which factors should you consider when selecting an IRT/RTSM vendor to ensure your trial's randomization and supply management processes are successfully executed?

• Is Your Clinical Supply Strategy Ready For EU CTR?

  One of the most significant changes in the new EU regulation is Annex VI, which covers changes in the labelling requirements for investigational medical products (IMPs). So, what are the implications of these changes and how will they affect outer immediate packaging? 

• A Practical Packaging Components Checklist For Emerging Biotechs

  A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

• Specializing In Small And Early-Stage Partners, Not Just Small Batches

  Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.

• Development And Manufacture Of A Highly Potent OSD Product

  Highly potent drug compounds require advanced containment and robust technical transfer protocols. CDMOs overcome challenges through meticulous testing, specialized tooling, and strong supplier relationships.

• Overcome Vaccine Development Complexities With The Right Supply Chain Partner

  Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.

• Tech Transfer Strategies For mAb Drug Products In Late-Phase Launch

  Tech transfer is not just a process of replicating manufacturing steps; it is a complex, multidisciplinary effort that ensures process robustness, scalability, regulatory compliance, and supply chain readiness.