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CompleClinical®
Ø Capture, manage, validate, and display all eClinical data using one efficient, integrated solution
Ø Log on with a single CompleWare unified user name/password to view all data at one Web location
Ø Perform central review of case report form (CRF), spirometry, electrocardiogram (ECG), and electronic patient reported outcome (ePRO) data
Ø Produce online reports and study metrics at the subject, site, and protocol level to follow study progress and metrics
HomeCDL™ and HomeCDL-Online™
Ø Collect diary and other ePRO, spirometry, Holter, and blood pressure data electronically between visits
Ø Enter physiological data online with no local database
ØFully integrated with other CRF data including ePRO data
Ø Generate multiple reports to follow study progress and metrics
Randomize IT®
Ø Enroll, randomize, terminate, and track subject visits
Ø Enter site data through two possible portals (telephone and Internet)
Ø Print enrollment logs and randomization data online 24/7 from the RandomizeIT® web site
Ø Receive randomization confirmations via email and fax
WebCDL® and ClinDataLink®
Ø Capture all physiological and laboratory data (e.g. spirometry, ECG, pulse oximetry) in the clinic using plug-and-play devices in a store-and forward system
Ø Define each clinical study protocol using a protocol wizard
Ø Export data to a central Web server where results can be viewed online and queries can be generated
Ø Generate and import queries electronically to eliminate paper and transcription of data
Ø Create a source document entry and a CRF entry simultaneously, electronically
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WebCRF®
Ø Integrate, manage, and view all clinical trial data with ultimate ease
Ø Define, modify and administer virtually any CRF with full validation and informative flags using an Administrative Tool, requiring no custom programming and ensuring rapid study start-up
Ø Track and resolve data management and monitoring queries online
WebEPRO®
Ø Allow subjects to enter ePRO data online
Ø View and manage all ePRO data fully integrated with other CRF data
Centralized Spirometry & ECG Review
Ø Software and hardware designed to collect and transmit data automatically, using the Internet, from sites to a central location where data are visualized on the web
Ø Full data management activities
Ø Centralized review of all spirometry, ECG and Holter data by highly qualified physicians, respiratory therapists, and technicians to assure the highest quality data and the proper interpretation of results
Ø Electronic annotations of ECG tracings by cardiologists using CompleECG™, producing HL7 compliant datasets that meet all requirements to be posted to the ECG warehouse
In-House Help Desk Services
Ø Live technicians providing knowledgeable support for site, CRO and sponsor personnel 24/7
Ø Streaming for troubleshooting and training
Ø Multi-lingual support for international studies
Full Service Contract Research Organization
| •Clinical Trial Design |
•Regulatory Submissions |
| •Monitoring |
•Data Management |
| •Statistical Analyses |
•Final Clinical Study Report |
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