Clinical Trial Labeling Services

New drugs used in clinical trials require specialized labeling to keep the drug product safe and any individuals testing it. When proper labeling practices are used in a clinical trial testing setting, the risk of errors is greatly reduced. 

For many years, Royal Label has been providing labels for healthcare companies and medical device labels, expertly and reliably meeting all of the regulatory requirements and adhering to FDA labeling regulations. You can trust Royal Label for your clinical trial labeling solutions.

Ensuring FDA Compliance through Professional Labeling

The FDA has several regulatory requirements for clinical trials, including the Code of Federal Regulations (CFR) statement on the label: “Caution: New drug — Limited by Federal (or United States) law to investigational use.” The label must also include:

• Trial identifier
• Clinical trial phase
• Drug product indication and usage instructions
• Sponsor’s and investigator’s names and addresses
• Product’s generic name, dosage, expiration date, concentration, strength, batch or lot number
• Instruction for safe storage

To reduce potential errors, Royal Label ensures that all clinical trial labels meet these compliance standards by following all FDA requirements that meet Good Manufacturing Practice (GMP) guidelines. This protects not only you but also those participating in the clinical trials.

Specialized Labeling Features for Clinical Trials

Clinical trial packaging and labeling must be done correctly to ensure that all standards are being followed and everyone’s safety is prioritized. Specialized labeling features are necessary to meet clinical trial labeling requirements. It is recommended that an experienced printer handle your clinical trial labeling needs. Royal Label offers comprehensive solutions, including labels for vials, blister packs, and cartons. 

Investigational Drug Labels

Investigation drug labels require specific FDA regulations. These labels must include the CFR statement. There cannot be any false information or information that may be interpreted as deceiving. It also cannot have any claims that the drug is safe or that it has been proven to be effective. 

Royal Label understands the importance of clearly visible CFR statements, cautionary statements, and instructions on how to use the product. That is why we handle all of these requirements with precision, following a detailed operating procedure to ensure that the final result is a high-quality product that follows all necessary guidelines.

Patient Information and Safety

Protecting the patient’s safety should be of the utmost priority. To ensure this is accomplished, Royal Label incorporates essential safety instructions as recommended. This can mean augmenting particular safety practices when creating labels, such as unique coloring, tall man lettering, utilizing different shapes, or implementing tablet imprinting to identify the product. 

The information on the label must be accurate and clear so that the patient is aware of any potential risks or the health benefits of the drug, ensuring patient safety. Instead of including an excessive amount of information on the outside label, it must include important information for the patient to be aware of, such as the name of the drug, its strength, and drug administration guidelines. 

By providing options such as panel labels and booklet labels, we optimize your labeling design to convey essential information without overcrowding the space. 

Reporting and Tracking

Effective tracking and reporting during the clinical study process involves making sure that every part of the trial has been observed and documented. Patient data must be well documented, any negative effects reported, the study’s progression reported, and key outcomes noted. 

Tracking is usually done by utilizing software systems specifically designed for clinical trial purposes. Reports are given to regulatory agents to review the information included. The whole purpose of tracking and reporting is to ensure that the trial process has been conducted ethically and has produced quality results. 

To enhance traceability and reporting accuracy, Royal Label uses controlled inventory management and automated inspection systems and can also produce barcode labels, RFID tags, and identifier codes to streamline the reporting process. For certain studies, randomization codes may be needed. We will work with our clients to generate these codes to help keep track of the clinical trial phases. 

Industries We Serve

Royal Label provides clinical labeling solutions to industries conducting clinical research studies, including:

• Pharmaceutical Companies: Labels are critical for tracking the effects, safety, and efficacy of drugs, medications, and vaccines. Companies like Merck and Pfizer rely on clinical labeling to comply with regulatory requirements and ensure safety.
• Medical Device Companies: Clinical labeling supports medical device trials by ensuring proper identification, usage instructions, and compliance with FDA standards.
• Biologics Developers: Precise labeling is essential for testing cell and gene therapies, supporting traceability and adherence to regulatory guidelines.

To adhere to the different needs and standards of the various industries, Royal Label offers designs that will meet your needs. We can also customize the labels to meet your exact specifications. We work diligently to ensure that all FDA requirements are met while also adhering to all clinical trial regulations, ensuring the safety of you and your patients. 

Why Choose Royal Label for Your Clinical Trial Labeling Needs

No matter your company’s label needs, Royal Label is dedicated to creating quality products that meet compliance standards. Our attention to customer service is evident in our personal approach, ensuring we meet your unique needs. Clinical trial labels require an extra level of care, consideration, and experience. Royal Label has assisted other customers with clinical labeling. Let us help you, too.

There is no project too complex for us. With all of our customization options and technical capabilities, Royal Label is a leader in clinical trial labeling and printing. To set up a consultation to review your needs or to receive product samples, please contact us at Royal Label.