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Case Studies
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Speeding the Development of Global Recruitment Materials
TCN e-Systems' e-recruitment tools expedited the development, translation, customization, approval, and implementation of multiple sets of recruitment materials for a multinational clinical study of a treatment for rheumatoid arthritis. As a result, the study enrolled within a few months, despite competition from many other RA studies.
Study
- Phase III study, consisting of 5 protocols
- 31 countries (36 languages)
- 275 sites
- 2,100 patients
Objectives
- Rapidly develop, translate, customize, gain approval, and distribute materials in order to maximize a short enrollment period.
Recruitment Challenges
- All materials would need to pass multiple legal and regulatory reviews.
Patient materials would also be subject to lengthy ethics committee review cycles.
Recruitment Challenges
- A short enrollment period created very tight development and implementation timeframes, within which multiple legal, regulatory, and ethics committee reviews would have to occur.
- Rapid development and management of a full complement of materials for each of three separate protocols, requiring 2,400+ pieces, translated, localized, and customized for individual sites.
Toolkit
| TrialCENTRALNet |
For centralization of all sites' information |
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StudyFORECASTER
with Country-By-Country Planning |
For development of optimal campaign roll-out plan |
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| SiteOPTIMIZER |
For determining sites' recruitment capabilities and materials needs |
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| MaterialMANAGER |
For fast, efficient development, translation, and customization of materials, as well as expeditious reviews and distribution of materials worldwide. |
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| RetentionBOOSTER |
For expeditious and cost-efficient training of sites on a country-by-country basis |
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Results
- Campaign roll-out plan maximized resources based on site initiations and ethics review timeframes.
- All materials were developed, translated, and customized on time.
- 95% of materials were approved by ethics committees with no edits.
- Materials reached sites according to the campaign roll-out plan, facilitating the study's on-time enrollment.
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