Updated: Aug 2
Here are 4 ways CSI maintains quality assurance in clinical trial supply.
Maintaining quality throughout a clinical trial is an ongoing process that requires consistency and management. Having a robust quality assurance process ensures the relevant quality standards, regulations and guidelines are met in each clinical trial.
What is quality assurance?
Quality assurance is a systematic process of checks and analysis that determines whether the clinical trial supply is up to standard and meets specific requirements. Three of the most common regulations and codes of conduct that clinical trials must adhere to are the Falsified Medicines Directive (FMD), Good Distribution Practice (GDP) and Good Storage Practice (GSP).
What is the clinical trial quality assurance process?
The clinical trial quality assurance process involves all trial-related activities and documentation. Using the trial design, protocol and system of checks, the process examines whether the trial is conducted correctly, the data produced is reliable and accurate, and whether regulations including the FDA, GDP and GSP are adhered to. There are many challenges that can disrupt the clinical supply chain and the effectiveness of your study. To ensure the clinical trial isn’t deemed below standard, it’s important to forecast risks and identify solutions throughout the duration of the study. This ongoing, dynamic process requires your team to be aware of the challenges and how to mitigate them and maintain communication with vendors and partners so that the quality of the study isn’t compromised at any point in the supply chain. The quality assurance process is in-depth and covers a breadth of areas from trial design to delivery. These activities can include examining trial sites, auditing suppliers and vendors, ensuring correct packaging and labelling, and maintaining suitable storage and distribution conditions. This plan will also consider the study design, site and data management, and the final clinical study report (CSR). Auditing this documentation examines whether the data represented is accurate and reliable, and ensures the study is compliant with GDP, GSP and FDA regulations.
How does CSI maintain quality assurance?
You should engage with a partner that understands the complexities of regulatory processes and timelines. We pride ourselves on our robust quality assurance processes that ensure the quality of every product and trial we help to deliver.
1. Dedicated quality department Our dedicated quality department’s sole function is to ensure that you receive the highest quality of clinical trial supplies so your study can run as smoothly and successfully as possible. To ensure your clinical trial supplies are thoroughly quality checked and assured, we provide: • Certificates of Analysis (CofAs) • Batch Release Certificates (BRCs) • Statements of Authenticity (SofAs) • Global market knowledge • Ethically sourced products
2. Qualification processes for suppliers and vendors We visit 90% of our suppliers, especially those based outside Europe. We manage the risks of outsourcing clinical trial supply partners by ensuring stringent processes that prevent issues including supply and delivery.
3. Global network Our global network of audited suppliers and manufacturers ensures we are compliant with regulations across the world. Our partners have local and regional market knowledge, regulatory knowledge, and are commonly part of the regulatory bodies themselves. Our partnerships ensure we know which processes to follow and how to best adhere to them.
4. Qualified Person (QP) services Our QP is a qualified pharmacist with 40 years of experience in compliance and quality control. We offer many services covering supply chain auditing including:
Auditing to GMP/GLP/PICS
Production of QP 3rd party declarations
Batch certification of investigational medicinal products (IMPs)
QP GMP certification of IMP or commercial packaging undertaken
IMPD support (simplified, full, compliance review)
Regulatory advice and support
Consultation with a QP
We also hold the IMP/MIA license, ensuring our quality management system is vigorous and robust.
CSI is a world-leading partner in clinical trial supplies and comparator sourcing
Working with an external clinical trial supplies partner can help to support your quality assurance process. Using our scientific ability and decades of experience in clinical trial and supply chain management, we implement robust quality assurance processes that ensure the integrity and accuracy of your study. By using our global network and strong relationships with audited suppliers, manufacturers, authorised distributors, and pharmaceutical wholesalers, we ensure your trial is compliant with differing regulations across the world. Get in touch with us to discuss your study requirements.