Pharmaceutical & Clinical Trial Label Translation for Global Studies

Drug study labels used in clinical trials provide essential information to physicians, subjects, and trial sponsors, including batch numbers, directions for use, drug strength or potency, expiration dates, package identifiers, storage conditions, and subject-specific codes. Each clinical-trial label identifies the investigational product, the study, and the trial participant.

In blinded studies, placebo labels must be visually identical to labels for active drugs, while still remaining istinguishable to the sponsor through controlled identifiers. Labels are often trial-specific, country-specific, and (where applicable) subject-specific, and must be applied accurately and, when required, permanently affixed to the container.

Sample Clinical Trial Drug Label (Illustrative Only)

Protocol No.: XXXXXX
XXXXXX, XXXXXX
Each carton contains 10 vials
Each vial contains 300 mg for subcutaneous or intravenous use
Refer to Pharmacy Manual for dosing instructions
Lot No.: XXXX
Expiry Date: MMM/YYYY
Store at 2°C–8°C (36°F–46°F)
Caution: For clinical trial use only
Sponsor: XXXXXX

CRO Document Services for Multi-Center Trials

Clinical trials often run in multiple countries at the same time and may require multilingual packaging. Labels typically must be reviewed and approved by the regulatory bodies in the countries where the trials will be conducted. As studies progress through each phase, revised labels may be required and submitted for approval.

Regulatory authorities commonly require that investigational medicinal product labels appear in the official language(s) of each country where the trial is conducted. These requirements may apply to outer packaging or, where no outer packaging exists, to immediate packaging, in accordance with applicable GMP and clinical trial guidance.

The label or labeling of an investigational new drug must not bear any statement that is false or misleading in any particular and must not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated. In the United States, the FDA requires that the immediate package of an investigationalnew drug intended for human use bear a label with the statement: Caution: New Drug—Limited by Federal (or United States) law to investigational use.

GTS is Your Reliable Partner for Certified Clinical Trial Translation Services

Drug study label translation can be challenging. The limited space and critical nature of label content leave no room for errors, which is why back-translation is sometimes used to help validate accuracy. Right-to-left languages such as Hebrew and Arabic add additional complexity because labels often combine right-to-left and left-to-right text. In many cases, PDF workflows help preserve formatting integrity better than editable formats.

GTS has translated drug study labels into French, Italian, German, Spanish, Danish, Flemish, Russian, Hebrew, Arabic, and many other languages. Clients we have supported include Novartis, Invidumed GmbH, Teva Pharmaceuticals, among others. When you need a reliable partner for Medical Document Translation Services, choose GTS.