Clinical Data Management (CDM)
Clinlogix’s global team includes experienced CDM professionals located in key geographic regions of the world, including the US, Europe, and South America. Our diverse team is comprised of industry experts in medical device and pharmaceutical services across multiple therapeutic areas. Our skill sets and expertise allows us to offer our clients cross-functional established teams and quality CDM data services.
Our clients are our number one priority. Clinlogix will work directly with you from study start-up to finalization of the trial. As a multidisciplinary team, we will be able to provide you with critical deliverables and timelines, best practices, manage budgets, and provide consistent trial execution and compliant quality data to ensure the success of your trial. We will clearly define the data sets, collection process, interpretation and reporting mechanisms to ensure the statistical accuracy of your trial whether for traditional designs or emerging strategies. Our exceptional cross-functional teams consist of:
- Project Management
- Data Analysts
- Dictionary Coding
Clinical Data Management Service
Clinlogix has been involved in the evolution of Electronic Data Capture (EDC) and other clinical systems for years as an industry driver. As a result, we have one of the most experienced eMonitoring and Project Teams. Within our EDC systems / Clinical Paper Trial System we can offer:
- Case Report Form design (CRF)
- eCRF design and review
- Database generation p-CRF or eCRF according to CDISC
- Double data entry (p-CRF) with quality control
- CDISC ODM compliant EDC systems
- Randomization functionalities within our EDC systems
- Trial Supply Management
- Dictionary Coding (MedDRA, WHO Drug)
- Automatic plausibility checks and query tracking
- Electronic data transfer from other parties (e.g., lab data, ECG data, etc.)
- Robust reporting capabilities, including dashboards, standard reports, and ad hoc reports
- Full 21 CFR part 11 compliance
- SDTM (Standard Data Tabulation Model) data sets at database lock
The Clinlogix Data Management environment is qualified and validated according to the GAMP 5 guidelines (“Good Automated Manufacturing Practice”).
Clinlogix CDM is 100% dedicated to our clients, so…Let our experience translate into quality expertise for you!!!