In clinical trials, documentation is not just an administrative task—it plays a crucial role in ensuring the safety, authenticity, and quality of pharmaceutical products.
These documents serve multiple purposes, from verifying the origin and authenticity of a product to demonstrating its therapeutic equivalence and quality.
Below, we explore why documentation is critical, the types of documents often required, and challenges that sponsors face in obtaining them.
Why is documentation required for clinical trials?
Pharmaceutical products used in clinical trials must adhere to strict regulatory and quality standards to ensure patient safety and the integrity of the trial data. Documentation forms part of the clinical trial submission to regulatory authorities and acts as evidence that these standards are being met. It is also evidence that each batch of a product is produced, stored, and distributed according to strict protocols.
Documents such as the certificate of analysis (CoA), GMP certificates, and batch release certificates provide the regulatory authorities, sponsors, and trial managers with confidence that a product is genuine, meets all necessary quality specifications, and is safe for use in human subjects. For example, a certificate of analysis confirms that a product meets its predefined specifications. It contains the actual results obtained from quality control testing and is signed by an authorised representative of the manufacturer. Without this document, there may be uncertainty about the product’s quality and origin, posing risks to patient safety and the trial’s outcomes
Common types of clinical trial documentation
- Certificate of analysis (CoA): Contains all information about the composition, purity, and quality of the drug and certifies that a regulated product meets its product specification. The CoA may also include batch-specific details.
- Certificate of conformance (CoC): Issued by an authorised body, this document attests that a product conforms to its technical specifications. It reassures stakeholders that the product possesses the qualities claimed by the manufacturer.
- Equivalency statement: When using multi-country sourced pharmaceuticals, this statement confirms that the product is therapeutically equivalent in each of the markets from which it is sourced and can be used interchangeably.
- GMP certificate: This certificate verifies that the manufacturing process adheres to Good Manufacturing Practices (GMP), ensuring that products are consistently produced and controlled to the quality standards appropriate for their intended use.
- Batch release certificate: This document certifies that a particular batch of the product is suitable for release and sale, confirming its compliance with regulatory and quality standards. Its verifies that the comparator drugs are consistent in quality and composition across different batches—hence avoiding confounding factors in the clinical trial results.
- First leg documentation: While not as commonly discussed, this refers to the set of documents that provide proof of the product’s journey from the manufacturer to the first point of receipt, typically a distributor or trial site.
- Import/Export certificates: Import and export certificates are critical for the legal and compliant transfer of pharmaceutical products across international borders. These documents ensure products meet the regulatory requirements of both the exporting and importing countries. They confirm the product’s safety, quality, and adherence to local laws, which is especially important for clinical trial materials being distributed globally. Import/export certificates help mitigate delays at customs, safeguard product integrity during transit, and provide assurance to trial sponsors that the pharmaceutical products have been handled appropriately throughout the supply chain.
Challenges in obtaining clinical trial documentation
While the importance of documentation is clear, acquiring the necessary documents can sometimes be a challenge. One common issue arises when manufacturers are reluctant to provide certain documents, particularly those that may contain proprietary or sensitive information, such as the Certificate of Analysis. Manufacturers may fear that revealing specific details could expose their intellectual property or give competitors insights into their formulations.
For example, certificates of analysis often contain detailed information about the composition of a product, testing methodologies, and results. In some cases, manufacturers may be hesitant to share this level of detail, especially for highly sensitive or innovative products.
Additionally, for global clinical trials, some countries may have unique regulatory requirements that demand specific documentation, such as equivalency statements or import/export certificates. The process of obtaining these documents can be complicated, and manufacturers may not always have pathways or an appetite to provide them promptly.
Overcoming clinical trial documentation challenges
There are numerous pathways to help navigate challenges in obtaining documentation:
- Understand requirements for documentation early: Sponsors and supply partners should consider document requirements in the early stages of trial design. Understanding what is mandatory and what is a “nice to have”, and whether study details can be disclosed to manufacturers, will influence sourcing strategy. Understanding what documents may be challenging to obtain allows for alternative solutions to be explored.
- Redacted documents: In cases where proprietary information is a concern, manufacturers may provide redacted versions of documents, ensuring that essential details like product quality and compliance are verified without exposing sensitive information.
- Agreements for documentation use: In some instances, a clinical trial may require documentation that manufacturers are hesitant to provide due to proprietary concerns. Establishing clear agreements that outline the terms for sharing necessary information can help protect the interests of both parties. These agreements ensure that the required documentation is used appropriately, while also safeguarding the manufacturer’s intellectual property and sensitive details. This collaborative approach helps streamline the process and fosters trust, ensuring compliance without compromising business interests.
Documentation is a critical element in the clinical trial supply chain, safeguarding the integrity of the product and the trial itself. While challenges in obtaining certain documents may arise, clear communication and alternative solutions, like redacted documents, can help overcome these hurdles. By ensuring that the necessary documentation is in place, clinical trials can move forward with confidence, knowing that the pharmaceuticals used meet all regulatory and quality standards.
This attention to detail in documentation not only ensures compliance with regulatory authorities but also builds trust between all parties involved—sponsors, trial partners, manufacturers and, most importantly, the patients whose lives depend on the safe and effective development of new treatments.
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Image by National Cancer Institute on Unsplash.
