Articles, App Notes, Case Studies, & White Papers

1. Enhancing Clinical IP Efficiency & Compliance 8/16/2024

   A U.S.-based clinical research sponsor optimized their supply chain visibility, reduced costs and risks, and improved efficiency by replacing their manual inventory management system.

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. Overcoming Cell Therapy Supply Chain Challenges 5/11/2021

   For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

4. My Worst Nightmare In RSTM: Accidental Unblinding 8/28/2023

   Learn how collaborative efforts from study managers, supply managers, biostatisticians, designers, and clinicians can better protect the blind in clinical trials and prevent accidental unblinding.

5. 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.

6. Unified Platform Supports Rapid Implementation Of Rescue Study 1/17/2024

   Explore how these integrated solutions helped an emerging biopharma to implement a plan for study build and migration with minimal disruption to sites.

7. Common RTSM/IRT AN Medication Pooling Questions Answered 11/21/2024

   Whether you’re planning a single trial or an entire program, medication pooling offers a pathway to cost-effective and sustainable clinical trial management.

8. 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.

9. Finding The Optimal IRT/RTSM Design For Your Clinical Trial 10/4/2024

   Determine the best IRT/RTSM design for your trial through consideration of the user, data collection, and future-proofing.

10. Investigational Medicinal Products: Labeling Changes And Their Implications 12/16/2022

    Learn about Annex VI, which covers changes in the labeling requirements for investigational medicinal products (IMPs) and harmonizes them throughout EU countries.