Pharmaceutical Translation Services

Make quality translation your competitive advantage

Now more than ever, language translation is a critical element to the success of global clinical trials and global regulatory submissions. Yet it is typically not a core competency of a pharmaceutical company, Clinical Research Organization (CRO) or protocol author.

Throughout the many stages of bringing a drug to market, translation is required including clinical research, regulatory submissions, manufacturing, marketing and packaging. While translation is the smallest line item in any global clinical trial or regulatory effort, translation can have a surprisingly large effect—for better or for worse—on several crucial factors. These factors include the total cost of the trials, the time to market, the possibility of lawsuits or rejection by regulators and even the safety and efficacy of the marketed product.

For instance, regulators sometimes reject applications or delay their approval if the required translations are inadequate. As a result, cost can increase dramatically, and market entry can be delayed by months, if not years, with loss of competitiveness.

DTS Language Services works diligently with pharmaceutical companies to make quality translations your competitive advantage by:

Managing the translation process

We directly oversee the entire translation process to protect our customers’ IP, ensure consistent, harmonized translation methodologies and reduce our customers’ trial risk profile.

Following best practices

We adhere to International Society for Pharmacoeconomics and Outcomes Research (ISPOR), International Society for Quality of Life Research (ISOQoL), and robust Standard Operating Procedures (SOPs) around all parts of the translation process – and establish a secure repository for all documents along with a well-established version control methodology.

Ensuring language consistency

We offer one centralized translation memory (TM) system to store your translations.  Using a single TM for each language direction, we increase translation speeds while ensuring language consistency.

Streamlining the review process

We have built a proven set of best practices thanks to our decades of experience in pharmaceutical and clinical trial translation – and we’ll apply them, so your review cycles are shorten and streamlined.

We’re willing to work directly with reviewers (whether internal or external) to ensure your translations are to the requested standards. Partner with DTS Language Services and make sure your trial translates to the best outcomes.

Extensive experience with highly technical documents

DTS Language Services has over a decade of experience in medical and pharmaceutical translation as well as with highly technical documents, such as:

• Case Report Forms (CRFs)
• Training Documentation
• Clinical Study Protocols
• Synopses
• Informed Consent Forms (ICFs)
• Patents and Patent Applications
• Chemistry, Manufacturing, and Controls (CMC) Documentation
• Quality Of Life Scale (QOLs) and other Patient Reported Outcomes (PROs)
• Packaging and Labeling
• Investigator Brochures
• Instructions-For-Use Inserts

Contact Us

Please call us at 800-524-0722 or fill out our contact form to find out how DTS Language Services can help you meet your translation requirements.