As more sponsors utilize electronic clinical outcome measures (eCOA) in their international clinical trials, these tools will also need to be accurately translated and culturally adapted for use in numerous languages and countries. eCOA translations must ensure that the scientific rigor of the paper-based clinical outcome measures (COA) is retained in the electronic version and can be used in trials around the world.
Benefits of eCOA
eCOA and other eClinical solutions such as electronic patient-reported outcomes (ePRO) have ushered in a new era of efficiency and precision in clinical trials. Using eCOA and ePRO to perform assessments can eliminate transcription errors, improve rater performance, and reduce missing data. These systems’ ease of administration and convenience of use enables patients and investigators to complete assessments effortlessly. Further, time-stamped entries and blocked skipping of questions result in more complete responses and more precise data. Automatic backups and built-in audit trails that track unique user IDs and patient credentials help to bolster data security.
Translation and Technology Cooperation
Timing is critical throughout eCOA development and the translation process. As soon as the study needs are identified, linguists and programmers should work in parallel to complete the various language versions of the eCOA assessments needed to service global trial sites.
VeraSci is the only language services provider to have a team of experienced developers, scientists, clinicians, and certified linguists in-house. This allows translations to happen in tandem with development activities. Scientific experts provide input throughout the process. Our commitment to quality is our mission and is backed up with 15 years of experience in the clinical trial industry. To support our in-house team, many of the VeraSci certified translators are also subject matter experts. Our processes are ISO 9001 and ISO 17100 certified, meaning that our resources and processes meet international standards for quality translations and client services.
The Price of Bad Translations
Substandard eCOA translations are a real threat to data integrity. In order to be considered valid, measurements from eCOA need to be equivalent to the data gathered from paper versions of the assessments. Incorrect translations of an eCOA can invalidate assessments performed in those languages, resulting in lost time and cost overruns.
Strict adherence to a scientific translation process ensures that eCOA translations stay true to the source and true to the science. Our process includes the preparation of a style guide, two independent forward translations, reconciliation of forward translations into one translation, back translation, internal quality assurance review of back translation against source text, scientific consultation, editing/reviewing of QA comments, implementation into software, and up to three rounds of screenshot review.
Using eCOA and ePRO can have many advantages. Carefully selecting a quality translation provider to tailor eClinical assessments to your global clinical trial reduces the risk of costly errors and invalid data. Don’t allow assessment translations to be an afterthought, but instead incorporate language solutions into the software development process. Our team can help maximize the accuracy of your data by providing scientifically sound translation and cultural adaptation services for eClinical software used in global clinical trials.
Learn more about VeraSci Global Language Solutions