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.
Kristin Knust
Lucas Barwick
Sumeela Nair
Filip Vyskocil
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
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
To learn more about how Emmes can help you with data management, please contact us.