The CompleClinical
® Suite enables all electronic clinical trial data to be captured, managed, validated
and displayed using an efficient, integrated solution:
WebCRF®:
Case report form (CRF) data
WebCDL®:
Physiological and laboratory data
(spirometry, spirometry challenge, electrocardiogram (ECGs), radiological images, pulse oximetry, blood
pressure, height, weight and point-of-care laboratory)
WebEPRO®:
Patient reported outcomes (PRO) (diaries, quality
of life measures, and other PRO endpoints)
Selected features:
- Uses administrative tools to define and administer the collection of clinical data with full validation and informative flags; manages protocols, sites, site users, sponsor users, and subjects
requiring no custom programming
- Offers device/platform independent collection, management, and display of clinical data (Web, smart
phone, interactive voice response (IVR), PDA)
- Performs edit checks across tables (e.g. across all visits) so that plausibility checks are
integrated and real-time data validation occurs to eliminate most study batch checks
- Provides central review of CRF, spirometry, ECG and ePRO data
- Allows rapid setup and deployment (typically in 1-2 weeks)
- Performs online data management, study management
- Provides extensive protocol specific portals
- Produces online reports and study metrics at the subject, site, and protocol level to follow study
progress and metrics online
- Allows multi-lingual data entry
- Generates online queries
- Allows remote monitoring of the study
- Allows one application to manage multiple protocols
- Uses CompleWare unified user log on (OneStop) to present all data at one Web location
- Is compliant with 21 CFR Part 11 requirements for electronic records
WebCDL®
