Clinical Research and Pharmacovigilance

Clinical trials and pharmacovigilance are both built around patient safety, whether prior to, during or after the process of discovery. Translations that are accurate, reliable and which facilitate patient understanding are then an essential part of informed patient engagement.

Clinical trials in humans drive progress in medicine, and involve patients and healthy volunteers across the globe. As a result, clinical trials have considerable ethical, safety and policy considerations, and require both tight regulation and accurate documentation.

In translating clinical research documents for multinational studies, consideration must be given to target audience:

• Patient-facing documents must be translated using language that is clear, accessible and easily-understood by the trial patient or subject.
• Physician-facing documents must be translated using more specialised language appropriate to the physician or researcher.

DWL thus ensures that the content of your documents is translated into the right language for the appropriate audience.

We have extensive experience translating a wide range of clinical research documents, including:

• Clinical study protocols
• Protocol synopses
• Informed Consent Forms (ICFs)
• Patient/Doctor information sheets
• Investigator’s Brochures (IBs)
• Trialists’ CVs
• Ethics Committee letters
• Case Report Forms
• Adverse Event Report (AER) forms
• Insert and label text/labelling
• Appointment reminders and follow-up cards
• Patient Reported Outcomes (PROs)
• Quality of Life (QoL) instruments
• Patient diaries and questionnaires
• Interim or final reports

Accurate translation is vitally important when it comes to patient safety. DWL has over 60 years’ experience translating clinical research documents, and operates within an ISO 9001 certified Quality Management System.

So you can rely on us for quality, tailor-made translation solutions.

The World Health Organisation (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects as well as any other drug-related problems.

DWL provides translation solutions for pharmacovigilance during all stages of the product lifecycle, from research and development, to marketing authorisation and post-authorisation.

We frequently translate Adverse Drug Reaction (ADR) reports, discharge summaries and other documents related to drug safety.