Clinical Data Management
Increase your productivity with our CDM Services. Using advanced technology and effective methods for clinical data management is critical to accelerate your clinical trial processes and build a competitive advantage. However, without the right expertise and clinical data management systems, data cleaning and query management can prove time-consuming and overwhelming. Clinovo partners with life science companies to help them increase their productivity with its outstanding CDM Services.
With Clinovo you get:
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Clinical Data Management Services
- Documentation (Data Management Plan, Edit Check Specification)
- Database User Acceptance Testing
- Data Entry
- Edit Check User Acceptance Testing
- Discrepancy and Query Management
- Forms Tracking
- Data Lock
- Documentation (Thesaurus Management Plan)
- MedDRA and WHOdrug classification
- Consistency review
- AE/SAE reconciliation
Laboratory Data Management
- Documentation (Lab Data Management Plan, Central Lab Data Transfer Plan)
- Local Reference Range Collection and Entry
- Applying ranges to lab test questions
- Conversion to reported units
- Paper CRF design
- CRF completion instruction
- CRF printing and distribution
Validated SAS®-based systems for Clinical Data Management
For faster, higher quality clinical data cleaning, at a lower cost
NEAT (Normalized Edit Checks Automated Tracking)
NEAT streamlines data cleaning for any Electronic Data Capture (EDC) system and accelerates the query management process. It provides clinical data managers with faster, more accurate data cleaning. NEAT was selected at WUSS Annual Conference 2010 as one of the most innovative SAS solutions.
OQMS (Online Query Management System)
OQMS is a powerful stand-alone query management system that tracks and monitors clinical data discrepancies that occur during clinical trials. OQMS was presented at PharmaSUG 2010, a premier venue for SAS professionals in the pharmaceutical industry.
CDISC® Express is a free SAS® application that automatically converts clinical data into CDISC® SDTM using an Excel framework. CDISC® Express significantly speeds up CDISC® conversion, thus resulting in faster FDA review.
Our EDC Expertise:
Our Electronic Data Management team is experienced in designing, building, and conducting studies using leading EDC systems, including Medidata Rave®, OpenClinica™ and Oracle™ Remote Data Capture (RDC).
Leveraging our unmatched technology and IT knowledge, we streamline your Electronic Data Capture process and help you increase the performance of your clinical trial.
Medidata Rave services: Clinovo supports the current industry leading Electronic Data Capture and Clinical Data Management System, Medidata Rave. Clinovo is able to tailor the Rave EDC platform to efficiently streamline the clinical trial process and achieve faster study build.
Open source EDC technology: We are early adopters of open source technologies. To help sponsors conduct faster, cost-effective clinical trials, we developed a powerful alternative to proprietary EDC systems, ClinCapture, 21 CFR Part 11 compliant and fully customized to your study protocol.