The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
- A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development
- What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
- What Biotech Sponsors Should Look For In A CDMO For Sterile Fill/Finish
- New Group Wants 'Phase-Appropriate' Thinking To Retire
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
Building Robust Clinical Supply Chains To Support Global Trials
Ensuring drugs reach patients at the right time and place is crucial. Review key areas to consider as you build a robust clinical supply chain that supports global trials effectively and efficiently.
-
How Long Is Your RTSM Risk Mitigation List?
While RTSM systems help reduce many of the risks in clinical trials, each trial’s unique setup necessitates a risk analysis to identify trial-specific challenges.
-
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.
-
How To Evaluate A Clinical Supply Chain Partner To Meet Vaccine Trial Needs
When selecting a supply chain partner, due diligence is critical. This article highlights questions you should be asking to ensure you are selecting the right supply chain partner for your clinical trial needs.
-
IRT: A New Approach To Meeting The Needs Of Early Phase Trials
As early phase clinical trials become more sophisticated, sponsors are now leveraging flexible IRT solutions to replace error-prone manual processes and gain greater control and efficiency.
-
Blinded Randomization And Trial Supply Management Gets Support
Uncover how this global specialty pharmaceutical company was able to ensure the confidentiality of its blinded study data while receiving flexible and scalable unblinded support.
-
What Are Decentralized Clinical Trials (DCTs)?
Discover how DCTs leverage “virtual” tools, such as telemedicine, sensory-based technologies, wearable medical devices, and direct delivery of study drugs and materials to patients’ homes.
-
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.
-
Providing Drug Supply Support In Complex Environments Through IRT
Learn how applying predictive data analytics can enable the creation of an ideal supply strategy capable of reducing the need for extra shipments, manual oversight, and supply waste.
-
Adapting Drug Supply Strategies To Modern Study Models
Advancements like remote-access drug refrigerators and smart packaging highlight the need for patient-centric trial models that integrate virtual and site-based activities to meet diverse patient needs.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.