Data Management Masthead

Data Management

Delivering efficient, quality-driven solutions that transform complex clinical data into trusted information, streamline timelines and maintain the highest standards of data integrity from study startup through database lock.

What we deliver

High-quality data is the foundation of every successful clinical trial. Our data management team keeps clinical data accurate and compliant, giving sponsors the confidence to make informed decisions throughout the study. Across early and late phase trials, we use proven processes, standardized tools and strong quality controls to deliver reliable, high-quality data on accelerated timelines, helping our sponsors move innovative therapies to patients faster. Sponsors receive:

  • Validated study-specific database builds
  • Clean, reconciled and submission ready data
  • Accurate, standardized medical coding 
  • Proactive continuous data review and query management 
  • A streamlined, efficient database lock process
2 – 4 Weeks
To database lock
4 Weeks
To database build
01

Study start-up

At study start-up, the team develops all required data management documentation and designs the database within our eSource/EDC system. We start with a library of CDISC certified eCRFs and use SDTM terminology throughout the database build. We have a robust UAT process, including time built in for sponsor participation.  

02

eSource and EDC

Our ClinSpark® eSource/EDC system integrates data from safety labs, ECGs, vital signs and volunteer data, eliminating transcription errors and reduce reconciliation efforts. For multicenter studies, Medrio® supports fast study startup while providing the flexibility needed to tailor database builds to each study.

03

Conduct

Throughout the study, our team continuously reviews data, manages queries and proactively cleans the database, with edit checks helping to identify and resolve issues early. External data transfer agreements are established early, and medical coding using WHODrug® and MedDRA® keeps terminology consistent across the study. Regular updates, clear metrics and ongoing sponsor communication keep everyone aligned, minimize end-of-study cleanup and support a rapid database lock.

04

Study close-out

At study closeout, our team completes final data cleaning, reconciliation and review to make sure the database is accurate, complete and ready for lock. We work closely with sponsors to address any remaining issues, confirm all required documentation is complete and ensure the study is fully prepared for database lock. Our goal is to make closeout as smooth and efficient as possible, with no surprises at the finish line.

Our data management leadership

Our Data Management team is led by experienced clinical data management professionals with expertise spanning study operations, database design and data quality oversight. The team delivers collaborative, quality-driven solutions that support successful clinical trial execution from startup through database lock. 

Cara White

Associate Director, Data Management

14 years of experience

Daniel Hudson

Manager, Data Management

12 years of experience

Kevin Stange

Manager, Database Design

18 years of experience

doctor on a laptop utilizing clinical data management services

Quality, standards and compliance

Quality is built into every stage of database design and data management from the beginning.

We leverage a library of validated eCRFs including edit checks so data is structured consistently for downstream analysis.

Robust edit checks support data cleaning by identifying discrepancies during conduct rather than at database lock. Early creation of Data Transfer Agreements (DTAs) and receiving test transfers results in timely external data reconciliation ahead of database lock. 

Our systems integrate data from EDC and eSource while using flexible reporting platforms to create customized, sponsor-specific reports tailored to each study’s needs. These reports provide timely, actionable visibility into data quality, study progress and key operational metrics, helping sponsors make informed decisions throughout the study lifecycle.

Connected across the full study lifecycle

Data management is integrated across the full study lifecycle, ensuring clean, validated data is available to support critical downstream activities. Validated datasets seamlessly support biostatistics, statistical programming and PK/PD analysis and/or modeling teams, while medical monitoring reviews clinical database medical coding as part of safety oversight. Your Project Manager serves as the central point of coordination, ensuring seamless handoffs throughout the study lifecycle.

Data Management Masthead

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