EDC & Trial Management

Our data management and statistics systems have been tried and tested on hundreds of clinical trials, delivering high quality data always on time. Whether EDC or paper-based trials, data can be made available for rapid review, providing your clinical team with the metrics and oversight that they ask for. We have experience of third party systems too frequently working directly with our clients’ in-house hosted systems.

The technology & benefits

• Secure web-based environment
• CDISC based standards (ODM/CDASH/SDTM/ADaM & define.xml)
• 21 CFR Part 11 Compliant
• Powerful data integration capability
• Utilising embedded Adobe technology, enriches trial management today while enabling new feature rich functionality tomorrow.
• System for EDC or paper CRF-based trials with powerful metrics and clinical oversight
• Can be deployed on all study phases
• CDISC based library approach
• EDC forms which retain the look and feel of paper that belies the powerful data validation within - site staff, monitors and investigators simply love it!
• EDC naïve sites can use the system with minimal training - ideal for post marketing surveillance and registry-type studies where data are provided from primary care sites
• Real-time web-based reporting presenting summary level information but with the power to drill down to the underlying detail
• Accommodates all industry standard data dictionaries as well as client-maintained instances
• Fully integrated data management functionality enhances data quality and flow while minimising the number of queries to site
• Maintain oversight of patient safety - simplify data preparation and review by Data and Safety Monitoring Board (DSMB)
• Email and SMS alerts to keep you informed of critical study and milestone events - we even have a smartphone app that can provide secure, real-time remote reporting on your phone
• Ask to see a demo of our offline EDC module – secure data collection, extensive validation on a standalone laptop or tablet PC for that moment when the internet lets you down
• High quality, functionally rich and one of the most budget-friendly services to be found

CRF/eCRF design

There’s much more to good CRF design than creating pretty forms, and, from experience, we know what’s required. CRFs should be easy to complete with supportive completion guidelines, and a design that enhances overall data quality. We have extensive experience of CRF design from most therapeutic areas, including the incorporation of patient diary cards and quality of life questionnaires.

Our CRF design benefits and beliefs

• Paper CRFs or EDC eCRFs using your corporate design, layout, data standards and livery
• Smart, flexible, cost-effective and punctual
• Intelligently designed CRFs that will actively support your study, encouraging reduced errors and the efficient handling of data
• Extensive experience in most therapeutic areas
• Print and distribution management
• CDISC ODM and define.xml automated procedures accelerates the CRF design/documentation and clinical database-build processes, particularly valuable in time critical EDC studies
• Translation of complex protocol into clear, precise instructions that enhance the data collection, management and reporting process
• Translation service for local language support
• Organisational skills to collate design comments from clinical stakeholders
• Adherence to strict deadlines
• Flexible print distribution management options for paper CRFs
• Investment in the state of the art forms and database technology delivers the sexiest forms and feature rich data collection experience available today – seeing is believing!

eCRF Form Building	eCRF Annotation
Reporting