Clinical Data Management
As a clinical research organization (CRO) founded by statisticians, data quality has always been our central focus. At Emmes, we are agile and flexible in our collaborations with clients to define, collect, manage and analyze data that supports their product development and public health goals. We realize the importance of the data our clients generate and its vital role in improving the health of people worldwide.
To deliver on our commitments to data excellence and public health, we have consistently invested in our people, technologies, and clinical data management processes while building a culture that enables data management teams to make valuable contributions to our clients’ studies. The longevity, skillsets, and customer service ethic of our data management professionals enhances day-to-day service and communication with clients, helping to keep studies on track.
When selecting Emmes to manage your biostatistics and other clinical trial data, you will partner with a team of highly trained data management professionals involved from initial study planning and protocol development onwards. Therapeutically aligned and integrated into clinical study teams, data managers work closely with statisticians, clinicians, medical writers, CRAs, investigative site personnel, and others to assure that data is collected and managed in an efficient manner at each stage of your trial. By focusing on data accuracy, integrity, security, timeliness and your therapeutic area, our research data management teams help you gain meaningful insights and achieve your study objectives quickly and affordably.
Emmes provides clients the flexibility of working with our Advantage e-Clinical suite of clinical technologies or using other industry systems. For over 20 years Emmes’ clients have leveraged Advantage eClinical, a 21 CFR Part 11 & Section 508 compliant suite of clinical technologies, to drive efficiencies in their clinical studies. Developed by data management professionals in concert with statisticians, clinicians, medical writers, and others, Advantage e-Clinical offers clients 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. To service clients who use other eClinical systems for data collection and management, Emmes possesses significant experience across a broad range of leading e-clinical technology platforms and open source systems.
Data Management Services
Emmes offers a full suite of clinical data management services to help you generate and analyze data for your clinical studies.
- Protocol development focused on identifying key data points required
- Electronic case report form (eCRF) design
- Development and validation of databases for EDC in clinical trials
- Patient enrollment, 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
- 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.