From Idea to Impact: Your Partner in Clinical Research That Matters
Within Prof. Thomas Meinel's (Study Director) DO-IT trial, the DCR Data Management team developed and implemented a centralized database integrating randomization, real-time data capture, and automated validation processes.
The system has been deployed across approximately 100 centers in Europe, Canada, and Australia, ensuring consistent patient selection and adherence to the study protocol. Real-time data entry, automated checks, and remote monitoring enhance data integrity and operational efficiency across all sites.
Data Management activities are embedded in the study infrastructure to ensure high-quality, reliable clinical evidence. DCR Monitoring supports this trial through continuous central data monitoring (CDM), ensuring high data quality by performing completeness, plausibility, and consistency checks, while also assisting sites with data entry.
KPI-driven remote monitoring further strengthens oversight of site performance, including protocol adherence, safety reporting (AEs/SAEs), recruitment tracking, and overall study progress. It also enables early identification of risks or irregularities and ensures completeness of essential documentation across sites.
REDCap
secuTrial
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Simple study design
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Surveys
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Complex study design
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Complex randomization models
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Blinded studies
Your choice of the system used should depend on the complexity of the study design and your needs.
We are happy to help you choosing the right system for your study.
Overview
DO-IT Trial
DO-IT is an international, multicenter, prospective, randomized, open-label trial with blinded endpoint assessment designed to evaluate the safety and efficacy of intravenous thrombolysis (IVT) in adults with acute ischemic stroke (AIS) who have taken a direct oral anticoagulant (DOAC) within the previous 48 hours.
A total of 906 participants will be enrolled across multiple high-volume stroke centers worldwide and randomly assigned in a 1:1 ratio to one of two groups: (1) IVT plus standard of care (best medical treatment), or (2) standard of care alone.
The trial aims to definitively test whether IVT leads to improved functional outcomes at 90 days compared with standard care in patients with AIS and recent DOAC use.
- Over 180 participants have been recruited in the study so far, at ~60 sites. Regulatory approvals have been received in Australia and Canada
Key Achievements
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke on Treatment With Direct Oral Anticoagulants: DO-IT - The DOAC Intravenous Thrombolysis Trial
Official Title
Prof. Thomas Meinel, Senior Physician, Head of the Neurological Emergency Team, Inselspital, Bern