DATA MANAGEMENT
Experience the next level of data flow and security in clinical trials.
As clinical information specialists, we provide a full range of clinical trial data management solutions to meet your specific needs. By combining industry-leading technology with our clinical data management expertise, we can create custom solutions tailored to your clinical trial and budget.
Our sophisticated approach to data management helps you successfully conduct all phases of clinical research across all therapeutic areas. Through our Oomnia® EDC/CTMS system, we facilitate a streamlined, effective data collection process, assure data quality and integrity, and resolve data discrepancies. Our clinical data managers will follow you every step of the way, from trial and site setup to the final database export and archive.
Wemedoo data management services range from study setup, eCRF and other EDC solutions, through the writing of the Clinical Data Management and Statistical Analysis Plans, statistical programming and analysis, to the final Statistical Analysis Report with TFLs. We can manage a complete trial process or accommodate a specific service, according to your needs.
EXCEPTIONAL EDC SOLUTIONS
Reduce costs by creating study-specific forms that will guide your team through the trial process with clarity and transparency. Our experts can create any type of EDC form, including custom reports and logs.
Flexible and Efficient Process
Meet study timelines in all trial phases with excellent data management planning and organization solutions. Our data management approach facilitates rapid eCRF and EDC form creation with convenient mid-study changes.
Database Proficiency
Expedite your workflows by using a smarter and more streamlined approach to all database processes. All EDC forms created in our system automatically generate auto-validating databases, thus ensuring absolute data precision and integrity throughout the entire data lifecycle.
Data Quality
Improve your trial efficiency by enabling your staff to rely on accurate data. Our auto-validating databases preclude the possibility of incongruent datasets, which, when combined with our custom and effective data management framework, ensures the highest data integrity standards.
Rapid External Integration
Improve the performance of your teams by relieving them of unnecessary reconciliation of data from disparate vendors and collaborators. We can integrate data from different systems, including electronic healthcare records, local and central laboratories, healthcare information systems, and more.
Timely Deliverables
Our vertically integrated data management, Oomnia® EDC/CTMS system, and statistical services ensure efficient and timely deliverables by a team that is well versed and uses integrated SOPs to reduce communication times and ensure high-quality, timely deliverables.
End-to-End Comprehensive Data Management Services
Study Set-Up
- eCRF/CRF design
- eCRF annotation
- eCRF implementation and validation
- Automatic edit check and trigger setup
- Setup / programming of custom on-demand reports
- Database design and setup
- Validation Report writing
- Clinical Data Management Plan writing
- Data transfer plan writing
- Setup of external data transfers, including:
- Central and local lab integration
- EHR / HIS integration
- Integration with pharmacovigilance, medical coding, and reporting systems
- EDC document creation, including:
- Site Initiation Visit Reports
- Monitoring Visit Reports
- Close-Out Reports
- Study Logs (temperature, visit, patient, site staff and responsibility, etc)
- WebPRO
- Much more
Study Conduct
- Data acquisition and storage management
- Data review
- Query management
- Data transfers with pharmacovigilance and other systems as necessary
- Safety data management and (S)AE reconciliation
- Custom in-trial reports
- Custom data exports
- Interim analysis
- Double data entry
- Real-time data review and reporting
Study Close Out
- Soft database lock
- Data preparation and cleaning
- Hard database lock
- Clinical data management report writing
- Database export
- Conversion of data to standard deliverables (CDASH, SDTM)
- Study close out documentation
- Study archiving
We custom tailor our solutions according to the customer’s needs. That’s why we assess each RFP on an individual basis to provide the most specific solutions and ensure accurate and timely deliverables.