While it is challenging to make precise predictions for clinical trial supplies, applying Bayesian statistics will help. This article shares steps to plan your Bayesian approach and how it helps to reduce waste and prevent shortages.
- Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy
- The Most Difficult Outsourcing Tasks
- Unboxing Genentech’s New Clinical Supply Center
- 4 Ways Academic Medical Centers Can Capture Greater Value In The Cell & Gene Therapy Industry
- Vendor/Supplier Management To Maintain A Drug’s Safety Profile In End-To-End Supply Chain Planning
- Strategizing The Scale-Up Of Cell Therapy Manufacturing Capacity
- New DSCSA Compliance Blueprint Includes FDA & Industry Input
- Strategic Procurement For Emerging Pharmas & Biotechs
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Controlled Substances In Clinical Trials
Handling controlled substances presents layers of complexity. Partnering with an experienced CDMO is essential for managing scheduled materials during clinical studies.
Managing Complex Global Drug Distribution And Expiry
A global top-ten pharma company sponsored a complex, 8-year Phase III trial across 43 countries. As costs mounted and supplies waned, it realized the trial could be better managed if outsourced.
When Protocol Amendments Meet RTSM: From Headache To High-Performance
Learn why an RTSM solution should be adaptive and flexible, and should help clinical trial teams uncover the best ways to handle protocol amendments.
Considerations When Selecting An Interactive Response Technology Provider
Interactive response technology (IRT) systems ensure clinical trial participants receive the correct treatment, facilitate enhanced logistics tracking, and empower users to obtain real-time data.
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.
24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments
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.
Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio
Learn how the CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study that needed to pivot to a decentralized protocol during the pandemic or face trial disruption.
3 IRT Tactics Being Used To Streamline Supply Logistics
Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.
Logistics, Transport Challenges Require Complex Solutions
The pandemic created additional obstacles for the clinical supply chain. Ensuring continued clinical trial operation requires an optimal management solution for clinical material supply.
Clinical Supply Optimization: Process Improvement Accelerates Trials
A biopharmaceutical sponsor required the study start-up phase to be reduced to 91 days, involving comparator sourcing and blinding, kitting, packaging, labeling, and distribution to the sites.