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Quality considerations when sourcing comparators for clinical trials

Updated: Jan 26

Quality control measures in clinical trials are essential to ensure the reliability, safety, and efficacy of the investigational medicinal product (IMP). Comparator medications are reference drugs used for comparison against the investigational drug, and their quality is crucial for valid study results. Here are some key quality control measures to be taken into consideration when sourcing clinical trial comparator medicines:

Qualified Suppliers: Ensure that the comparator drugs are sourced from qualified and reputable suppliers. These suppliers should have a proven track record of providing high-quality pharmaceutical products. Regular auditing is crucial to verify their adherence to quality standards.

Handling and Storage: Implement procedures in line with Good Distribution Practices (GDP) for the handling, transportation and storage of the comparator drugs to maintain their quality and integrity. This includes temperature monitoring and control throughout transit and storage.

Documentation: Certificates of Analysis (CoA) can be obtained for each batch of the comparator drug which contains all information about the composition, purity, and quality of the drug and certifies that a regulated product meets its product specification. Batch Release Certificates verify that the comparator drugs are consistent in quality and composition across different batches; variability between batches could introduce confounding factors in the clinical trial results.

Regulatory Compliance: Ensure that the sourced comparator drugs meet all relevant regulatory requirements in the countries where the clinical trial is being conducted. This includes compliance with the International Conference on Harmonisation (ICH) guidelines and local regulatory agencies.

Quality Oversight: Designate a Quality Control team and Qualified Person to conduct regular inspections and audits to ensure compliance with quality standards. Qualified Persons are responsible for certifying the release of investigational products for use in clinical trials and provide an additional layer of oversight to ensure quality and compliance.

Risk Management: Identify potential risks associated with the comparator sourcing process and develop strategies to mitigate these risks effectively.

Traceability: Maintain a complete and auditable trail of the sourcing process, from supplier selection to drug delivery. This ensures traceability and accountability in case any issues arise during the trial.

Training: Ensure that all personnel involved in the comparator sourcing process are appropriately trained and educated about the importance of quality control and compliance with relevant procedures.

Labelling: Proper labelling should be in place to ensure the correct identification and use of the comparator drugs to maintain the integrity of the trial.

Handling of Product Returns and Destruction: Ensure there are procedures in place for handling returned or unused investigational products and for the proper destruction of expired or unusable products.

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

We have a dedicated quality department whose primary mission is to ensure that you receive the highest quality 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.

We establish quality agreements with suppliers that define responsibilities, quality expectations, and procedures for deviations and issue resolution. These agreements help create a clear understanding of quality-related roles and responsibilities between the sponsor and the supplier.

3. Global network

Through our extensive global network of audited suppliers and manufacturers, we maintain strict compliance with regulations worldwide. Our carefully chosen partners possess in-depth knowledge of local and regional markets, as well as regulatory expertise, often being affiliated with regulatory bodies themselves. These strong partnerships enable us to navigate the necessary processes effectively and adhere to them with precision.

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 in 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

· CSI has QPs both in the UK and in Europe


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