Clinical Data Management

Agile and flexible, we work collaboratively with you to define, collect, manage and analyze the quality data that supports your product development and public health ambitions.

To deliver your goals, we invest in our people, technologies and clinical data management processes. And we’ve built a culture where data management teams are empowered to make valuable contributions. Their skillsets and service ethic enables clear communications and study progress.

We partner with you to manage your clinical trial data, from initial study planning and protocol development onwards.

Our data managers are therapeutically aligned and integrated into clinical study teams, working closely with statisticians, clinicians, medical writers, CRAs, investigative site personnel, and others to ensure that data is collected and managed in an efficient manner at each stage of your trial.

This focus on data accuracy, integrity, security, timeliness and your therapeutic area, enables our clinical data management teams to gain meaningful insights and achieve your study objectives, quickly and
affordably.

Clinical Data Management Leaders
Kristin Knust
Kristin Knust
Associate Vice President, Data Management
Lucas Barwick
Lucas Barwick
Associate Director, Data Management
Sumeela Nair
Sumeela Nair
Senior Director, Data Management (India)
Filip Vyskocil
Filip Vyskocil
Director, Data Management (Europe)
People
  • Highly trained
  • Accountable
  • Focused on clean and timely data
  • Committed to data quality
Process
  • DM integrated into study teams
  • Therapeutically aligned
  • Efficent and quality driven
  • Focused on generating insights on study endpoints
Technology
  • Advantage eClinical experts
  • Templates to reduce timelines
  • Risk based and remote data monitoring
  • Fluent in Rave and other EDC
Culture
  • Intellectually curious
  • Collaborative
  • Problem solving
  • Open, transparent, communicative with sites and clients

Success

For more than 20 years, our clients have driven efficiencies in their clinical studies with Advantage eClinical. A 21 CFR Part 11 & Section 508 compliant suite of clinical technologies, Advantage eClinical has been developed by data management professionals in collaboration with statisticians, clinicians, medical writers, and others.

Advantage eClinical offers you electronic data capture (EDC) for case reporting, IRT for patient enrollment and drug management, ePRO to collect patient insights, safety and pharmacovigilance tracking, MedDRA/WHO drug coding, specimen tracking, and more. We also offer exceptional experience across a broad range of leading e-clinical technology platforms and open-source systems.

Experience Sheet

More information on our Clinical Data Management services

Data Management Services

Data Management Services

Our full suite of clinical data management services can help you generate and analyze data for your clinical studies:

  • Protocol development focused on identifying required key data points
  • Electronic case report form (eCRF) design
  • Development and validation of databases for EDC in clinical trials
  • Patient enrolment, registration and site activation
  • eConsent development
  • Patient safety and pharmacovigilance tracking and reconciliation
  • Electronic patient reported outcomes (ePRO) collection and analysis
  • Specimen tracking and laboratory management
  • Reporting tool configuration
  • Development and management of clinical trial websites
  • CDISC and statistical programming support
  • Electronic filing of regulatory submissions following CDISC guidelines
  • Medical coding
  • Clinical data management training for site personnel
  • Data queries, resolution and cleaning
  • Data integration services
  • Prompt and efficient database lock
  • Database maintenance and archiving
Schedule a Meeting

To learn more about how Emmes can help you with data management, please contact us.