DTS CASE STUDY
CRO Needed Help Managing Translations for Large Global Clinical Trials Study
A global CRO approached DTS about a large, on-going clinical study that would last for several years and involve participating patients from over 50 countries. There were a series of Patient Recruitment documents, Patient Diaries, Case Report Forms, and Informed Consent Forms that would need to be translated initially, and over the lifetime of the study. The CRO was confident in having the English materials written, designed and approved, but they needed help carrying out and managing the translations.
Their translation challenges included the following:
- Language Advisement: What target languages were used by certain countries?
- Translation Reviews: What best practices could they use to work with the Sponsor?
- Scheduling: What timelines would be committed to? What about contingency scenarios?
- Budgeting: How much would the translations cost? How long would it take for a proposal?
- Project Changes: What would happen if documents were replaced or modified once the translations had begun?
- Quality Control: What QA assurances could the CRO provide to the Sponsor?
- Ethics Committee (EC) Approval: How would this be incorporated into the milestones?
- Future Document Access: Could the translations be easily accessed in the future?
DTS approached the CRO with a proposal to address all topics and more. The DTS proposal included a comprehensive planning and checklist process which addressed all of the above areas of concern. All translation costs were clearly itemized and were based on languages which DTS suggested for each country. Furthermore, all QA processes were specified in advance with timing milestones for each of the CRO’s respective documents.
DTS also hosted an initial kick-off meeting to include the CRO and Sponsor, so that all sides could confirm the details and manage expectations up front. This allowed for open dialog and when there were adjustments to be made in the middle of the project (replacement documents, document changes), DTS was able to swiftly suggest the best course of action to modify the document translations and version dates.
DTS also provided guidelines to the CRO for managing the In-country translation review processes, which saved months of potential conflict/confusion time if there were not any guidelines provided.
DTS also helped the CRO prepare for their weekly conference call sessions with the Sponsor by providing timely updates.
The resulting outcome was that 100% of the languages initially planned on were submitted for release. The document translations were uploaded in a secure portal with controlled access, as well as all Translation Certificates for the more than 60 language directions. In addition, all translations were warehoused in language data bases engineered by DTS, to make future document version updates go much faster and cheaper.
This expediency of the translation process and document management control system benefited the CRO, the sponsor, the sites, and ultimately the patients in the clinical trial. All translated documents were provided in hi-res PDF format for the CRO’s printer, using their printer’s preferred settings, which helped save even more time and money.
The sponsor was able to enroll international sites quickly, and begin the study without any hitches, delays or costly setbacks, after the Ethics Committees gave final approval of the translations.
DTS provided Translation Certificates for all language directions, which were archived and easily accessible to the CRO. Finally, a final post-mortem was conducted to unearth ways to refine the process in the future and identify areas that could be strengthened in the future. DTS, the CRO, and Sponsor provided open channels of communication which was the whole key to the shared success of the translation project.
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