In recent years, clinical service provider organizations have had to reinvent themselves to keep up with a continually growing and fast changing industry. COVID-19, decentralization, growth of biologics and adaptive trialshave all put pressure on the traditional outsourced supply chain. Forward-thinking pharma sponsors and clinical service providers are collaborating closely and exploring new ways to bring drugs and medical products to market.
To work more effectively and bring investigational products to trial faster, the need for outsourcing has seen a surge globally. This inevitably brings new challenges and complexities around label management with multiple parties involved.
Now more than ever, content and label management is a crucial part of the clinical trial contract supplies chain. If something is labeled incorrectly, the chain breaks, leading to trial delays, non-compliance to regulations and most importantly putting patients at risk. In particular, delays with obtaining production-ready labels can be an unfortunate occurrence that can postpone trial start with significant financial burden.
As clinical research evolves, so must the labeling technologies, processes and services in order to meet these new demands. By utilizing cloud-based label design and content management applications, clinical service providers’ operations can be streamlined, giving the ability to support different production and supply models, as well as evolve service offerings, thereby gaining competitive edge.
Key Learning Objectives
- Understand how changes in clinical research are driving transformation within the clinical trial supply chain
- Learn how this shift is driving clinical research outsourcers and service providers to expand their service offerings, including labeling design and content services including:
- Booklet Design Services
- Translation Services
- Randomization Services
- Discover how service providers are meeting new supply models, such as ‘direct to patient’, utilizing Just In Time (JIT) production
- See how clinical trial-specific labeling applications are being used by service providers to become a more valued partner for sponsors, by being more agile and flexible
Audience
- Clinical Research Organizations (CRO)
- Clinical Development & Manufacturing Organizations (CDMO)
- Clinical Supplies Organization (CSO)
- Pharmaceutical R&D