Clinical Data Management Service

Meticulously detailed and flexibly delivered, Precision’s clinical data management services team delivers data you can trust using the EDC that works for your study. Working hand-in-hand with you and study site personnel, our reliable team ensures you extract maximum insight from your biomarker-driven clinical trial.

Clinical Data Management Service

Meticulously detailed and flexibly delivered, Precision’s clinical data management services team delivers data you can trust using the EDC that works for your study. Working hand-in-hand with you and study site personnel, our reliable team ensures you extract maximum insight from your biomarker-driven clinical trial.

Precision excels at clinical data management service

Ensuring data integrity from start-up to submission

End-to-end coverage

The same reliable data management team with indication-specific expertise supports your project every step of the way:

Start-up
  • Develop custom data management plan based on your protocol, study site needs, and your needs
  • Use best EDC for your needs
  • Design CRFs and write CRF guidelines
  • Coordinate data-in

 

Database development
  • Build and screen the database, including testing and QC
  • Coordinate user acceptance training (UAT) with sponsor and study site
User administration
  • Set up accounts
  • Conduct training
Database conduct
  • Data Cleaning
  • Query Resolution
  • Medical Coding
  • External Vendor Data Transfers & Reconciliation
  • SAE Reconciliation
  • Ongoing EDC Metrics, Clean Submit Report
  • ‘SMART’ Patient Profiles

 

Database lock
  • Obtain PI signature
  • Lock CRFs
  • Generate final datasets
  • Site CRF Archival CDs
  • Decommission EDC

Case Study: Securing FDA approval for a new diagnostic when compared to the “gold standard”

Throughout this Phase I immunotherapy trial, the team collected samples to evaluate tumor biomarker expression and activity, as well as the degree and type of immune infiltration by immunohistochemistry. However, until the final cohort was reached without demonstration of adverse events, these were not analyzed in conjunction with the clinical data.

Upon completion of the final planned dosing cohort, the question remained, “did we achieve the final ‘optimal’ dose for more robust evaluation of efficacy, or were further refinements to dosing needed?” Without clinical evidence, it was necessary to rely on biomarker and immunohistochemistry data for insights.

Tell us about your project requirements

Integrity matters, whether it’s describing your study data or the teams generating and managing your study data. Ensure integrity with Precision.

Tell us about your project requirements

Integrity matters, whether it’s describing your study data or the teams generating and managing your study data. Ensure integrity with Precision.

Clinical trial services

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Clinical Trial Design

Advanced trial-design approaches-including basket, umbrella, and adaptive trials-deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Biostatistics

Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.

Clinical Sample Management

Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.

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