"Database lock is in six weeks, and we're still finding queries nobody opened."
Data Management
Clean data at lock is not luck. We build the EDC and the quality process so what reaches the FDA is complete, traceable, and defensible, from eCRF design through archival.
Talk to a data manager
Quality-first data, fully compatible with SDTMs and ADaMs
Our reliable team works closely with clients and study sites, ensuring active communication from the start. We collaborate to build a database that yields clean, quality data, leveraging diverse team skill sets to deliver data that is downstream-ready by design.
That same expertise makes us an ideal partner for data and CRO monitoring on studies where another vendor holds the database.
Clinical data management services
Trial Master File setup & maintenance
Query management
CRF design and development
AE, ConMed & medical history coding
Interactive CRF review meeting
Import, integration & cleaning of electronic data (lab, ECG, PK)
CRF completion guidelines
Continuous data cleaning
Data Management Plan development
Study metrics via online dashboard
EDC training for sites and monitors
SAE reconciliation between safety and clinical databases
User administration
Database lock
Database design & development
Site CRF archival
Clinical database creation & validation
Project change requests
Custom status reports
Study closeout
Frequently asked questions
What does Pentara's Clinical Data Management do? +
- Ensures data quality and integrity. Our CDM team captures, reviews, cleans, and validates data so it is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+).
- Protects patient safety. We review, reconcile, and code adverse events, concomitant medications, and medical histories.
- Supports valid efficacy conclusions. Accurate, reliable data lets researchers properly assess safety and efficacy, the basis of evidence-based medicine.
- Facilitates informed decisions. High-quality data provides insight for better decisions about care, treatment plans, and diagnoses.
- Enables effective analysis and reporting. Clean, well-structured data plus custom dashboards and reports that are easy to interpret.
What makes Pentara's Clinical Data Management successful? +
Our standard practices ensure data meets the stringent requirements of regulatory bodies. Employees are trained in CDISC standards, and CDM implements CDASH conventions when developing eCRFs, accelerating downstream programming and analysis, which makes for quicker FDA submissions and brings the drug or device to patients earlier.
What EDC systems does Pentara use? +
Pentara has extensive experience with multiple EDC systems, including but not limited to Medidata, Medrio, and REDCap.
Least expensive point to bring us in · First patient in
Standardization and audit-trail design from the first record. Later, you rebuild the trail during an inspection.
Clean data, from first eCRF to archival
Tell us where your database stands and we'll show you what to fix before lock.