Articles, App Notes, Case Studies, & White Papers

1. Navigating New EU Clinical Trials Regulation Requirements For Clinical Supplies

   Better understand Clinical Trials Regulation No. 536/201 (CTR) labeling changes and their potential to disrupt traditional clinical supply strategy that adhere to the new requirements.

2. Key Considerations For Labeling Your Cell Or Gene Therapy

   As sponsors focus on maintaining the temperature range required for cell and gene therapies, they must also keep in mind the challenges this task presents when properly labeling them for clinical trial distribution.

3. A Smart Solution To Clinical Supply Management 10/28/2022

   Delve into a solution that ensures the efficient delivery of trial materials worldwide, while navigating the challenges of more complex study designs and the ever-evolving regulatory landscape.

4. Data Analytics For Better ClinRO Quality 2/21/2025

   Many trials fail not because of ineffective treatments, but due to challenges in detecting treatment signals. Explore how advanced data analytics can improve ClinRO quality.

5. Outlook 2025: Key Trends & Insights 2/19/2025

   Dive into the key trends and challenges shaping the year ahead, from geopolitical uncertainties to cutting-edge innovation in AI, oncology, and weight-loss therapies.

6. 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.

7. Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions 12/8/2023

   Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.

8. Planning Your Packaging For A Seamless Transition From Clinic To Launch 7/19/2022

   Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.

9. 5 Ways To Get Ready For IRT Regulatory Inspections 7/31/2025

   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.

10. 24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments 3/1/2023

    Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.