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Data Management

Pentara ensures successful clinical trials by prioritizing data integrity. Our experts offer comprehensive data management, from eCRF design to study archival, using industry-leading EDC technologies to guarantee high-quality and secure data for clients.

Pentara's reliable team works closely with clients and study sites, ensuring active communication from the start. They collaborate to build a desirable database that yields clean, quality data. Pentara's unique approach leverages diverse team skill sets to deliver quality-first data fully compatible with SDTMs and ADaMs.

Clinical Data Management Services:
  • Data Management Trial Master File Set-up and Maintenance
  • CRF Design and Development
  • Interactive CRF Review Meeting
  • CRF Completion Guidelines Development
  • Data Management Plan Development
  • EDC System Training for Sites and Monitors
  • User administration
  • Database design development
  • Clinical database creation and validation
  • Development of Custom Status Reports
  • Query Management
  • Adverse event, Concomitant Medication and Medical History Coding
  • Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, etc.)
  • Continuous Data Cleaning
  • Study Metrics provided through an online accessible Dashboard
  • SAE Reconciliation between Safety and Clinical Databases
  • Database Lock
  • Site CRF Archival
  • Project Change Requests
  • Study Closeout

Frequently Asked Questions

  1. Ensures Data Quality and Integrity: Pentara’s CDM team captures, reviews, cleans, and validates data to ensure it is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent and Available (ALCOA+), which is vital for the reliability of clinical research.
  2. Patient Safety: By reviewing, reconciling and coding adverse events, concomitant medications and medical histories, Pentara’s CDM plays a critical role in protecting patient health and safety during clinical trials.
  3. Aids in the Validity of Treatment Efficacy: Accurate and reliable clinical data allows researchers to properly assess the safety and efficacy of new drugs and treatments, forming the basis for evidence-based medicine.
  4. Facilitates Informed Decision-Making: High-quality data provides insights that help healthcare providers make better decisions about patient care, treatment plans, and diagnoses.
  5. Enables Effective Data Analysis and Reporting: Clean, well-structured data provides end users with compliant and intuitive datasets. Clinical Data Management creates custom dashboards and reports that are easy to interpret and valuable for trial insights.
Pentara’s standard practices ensure data collected during clinical trials meets the stringent requirements of regulatory bodies. Employees are trained in Clinical Data Interchange Standards Consortium (CDISC) standards. CDM implements CDISC’s Clinical Data Acquisition Standards Harmonization (CDASH) conventions when developing electronic Case Report Forms (eCRFs), in turn accelerating downstream clinical programming and data analysis, which makes quicker FDA submissions, bringing the drug/device to the market and patient earlier.
Pentara has extensive experience with multiple EDC Systems, such as, but not limited to, Medidata, Medrio, and REDCap.