Clinical Data Management.
Experience the next level of data flow and security in clinical trials.
Our clinical data managers help you successfully conduct all phases of clinical research from trial and site setup to the final database export and archive and across all therapeutic areas. According to your needs, we can manage the complete trial process, or accommodate a specific service.
Our Oomnia® EDC/CTMS system facilitates streamlined, effective data collection processes, assures data quality and integrity, and resolution of data discrepancies.
Professional Services
eCRF/CRF design
eCRF annotation
eCRF implementation and validation
Automatic edit check and trigger setup
EDC document creation, including Monitoring Visit Reports
WebPRO and/or ePRO
Setup / programming of custom on-demand reports
eCRF Validation Report writing
Clinical Data Management Plan writing
Data Transfer Plan writing
Setup of external data transfers, including integration with pharmacovigilance, medical coding, and reporting systems
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
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
Exceptional EDC Solutions
Reduce costs by creating reusable or study-specific EDC 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 seamless 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.
Superior Data Quality
Improve your trial efficiency, 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, ensure the highest data integrity levels.
Rapid External Integration
Stop unnecessary reconciliation of data from disparate vendors and collaborators and improve the performance of your teams. We 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. Our team is well versed and uses integrated SOPs to reduce communication times and ensure high quality, timely deliverables.
