Data Management
We are committed to supporting your company from the design of the clinical trial to study close, and ensuring the highest level of data quality. We offer robust systems that meet regulatory guidelines (FDA, EMA) and conventions, including 21 CFR Part 11 and ICH-GCP.
Let the knowledgeable experts at Pharmapace guide your company through the entire data management lifecycle.
Our data managers work to ensure on-time results of your clinical trial data. Pharmapace delivers your data before critical deadlines. While we offer quick turn-around times, we never sacrifice the quality of our results.
Keys to Successful On-Time Quality Data:
- Data Management Vendor Selection
- Contract Negotiation
- Vendor Management
- Timeline Management
- Electronic Case Report Form (eCRF) design
- Database build in EDC system
- EDC setup including User Acceptance Testing (UAT)
- Data Management Plan (DMP)
- CRF Completion Guidelines
- Programming of Complex Edit Checks
- Data Review and Query Management
- Third party Data Reconciliation (Central Labs, SAE Database)
- Thesaurus coding management- Safety Data and Concomitant Medications
- Database Lock and Archive