Pharmaceutical Labelling for Effective Clinical Trials
Labelling plays a crucial role in maintaining the accuracy, integrity and relevance of clinical trial data. This is more so important when multi-site trials cover international locations. In many instances relabelling, or additional labelling, may be required for the modification of investigational medicinal product (IMP) labels to meet regulatory requirements from country to country.
Key points about the importance of pharmaceutical labelling within clinical trials include:
Regulatory compliance: Clinical trials are subject to strict regulations to ensure patient safety and data quality. Accurate pharmaceutical labelling ensures that medicinal product information, usage and dosage instructions, warnings and precautions are clear. This is essential for correct record keeping for regulatory inspections and audits, demonstrating adherence to protocols and required guidelines. Non-compliance can lead to regulatory issues, delays, or even trial discontinuation.
Product identification: It’s evident that clinical trials often encompass various investigational drugs, placebos, and comparator drugs. An accurate pharmaceutical label plays a crucial role in precisely distinguishing each product, thereby reducing any potential confusion or errors and ensuring the correct administration of the product to the intended patient.
Blinding in Clinical Trials: In blinded clinical trials information about the test, such as details regarding the division of patients into groups and assigned product, is concealed from the participants. In double-blind clinical trials, both participants and researchers are unaware of the treatment assigned. Proper labelling helps maintain blinding by ensuring that the appearance of the information on medicinal packages does not reveal the treatment being administered. Blinding excludes the subjective factor, which may influence the experiment results.
Document and data accuracy: Accurate pharmaceutical labelling is essential for maintaining proper records which are required during regulatory inspections and audits.
Supply Chain Management: Effective pharmaceutical labelling assists in managing the drug supply chain within clinical trials. It helps in tracking the movement of drugs from manufacturers to investigational sites, minimising the risk of drug shortages or mismanagement.
Language and Local Requirements: Consideration for different languages and local requirements is crucial for multinational clinical trials. Labels should be translated accurately to ensure clear understanding by diverse patient populations and adhere to specific country regulations.
Pharmaceutical Label Requirements
Pharmaceutical label requirements for Investigational Medicinal Products (IMPs) are essential for conveying the precise details of a product. Labelling information may include:
- Trial code (if not given elsewhere)
- Product name
- Batch number
- Expiry date and/or retest date
- Dosage
- Route of administrations
- Warnings, if necessary
- Storage conditions
- Manufacturer and/or Sponsor names
- Instructions where relevant
- Blinding and Randomisation Codes
- “Keep out of reach of children” except when the product is for use in trials where the product is not taken home by participants.
In certain cases, additional labelling may be necessary to augment the information provided on an existing label for planned Comparator or Standard of Care (SOC) drugs. This additional labelling may encompass:
- The name of the sponsor.
- The study number.
- “For clinical trial use only” or similar wording
Just in Time (JIT) Labelling
Just in Time (JIT) labelling enables the production and application of labels shortly before they are administered to study participants. This is a flexible approach and means that labels can be adapted for the needs of specific countries, clinical sites or patient requirements. This helps streamline the clinical trial process minimising drug waste, accommodate a variety of geographic locations and provide a more efficient distribution of medicinal products.
Pharmaceutical Labelling, Packaging and More from Oximio
Clear and accurate labelling demonstrates a positive public perception of pharmaceutical companies and indeed, the clinical trial process providing transparency, adherence to regulatory requirements and ethical standards.
At Oximio we understand that patient safety is a priority in any clinical trial. That’s why, for almost 20 years, we have built a reputation of delivering reliable, end to end, clinical trial services including labelling and packaging solutions. With our own depots, bonded warehouses and extensive partner network depot, we can provide a complete solution across the globe.
To find out how we can support your clinical trial please contact us.