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CompleWare Corporation

Description: 

CAPTURE AND MANAGE CLINICAL RESEARCH DATA USING INTEROPERABLE, INNOVATIVE TECHNIQUES TO IMPROVE SPEED, ACCURACY, AND EASE OF THE DATA ENTRY PROCESS


CompleWare Corporation, a leader in the use of eTechnology to conduct clinical trials, provides lean eClinical innovation, integration, and quality leading to increased speed and accuracy of data capture, enhanced subject compliance, and controlled study costs. CompleWare is a full service CRO with a focus on, and expertise in, the management of respiratory clinical studies; including full centralized spirometry and ECG capture, as well as, home subject data management employing all available ePRO options.

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

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


Compleware®... lean eClinical Innovation, Integration and Quality!

Services: 

Cardiovascular Monitoring/Pulmonary Diagnostics, Clinical Trial Monitoring, Data Management, Electronic Data Capture, Electronic Diary/Dictionary/Translator, Project Management, Protocol Development, Remote Data Entry, Software Development & Evaluation, Spirometry/Challenge Testing

Contact Information: 

CompleWare Corporation
P.O. Box 3090
Iowa City, IA, 52244-3090, USA
Phone : 3196268888
Fax : 3196268750
Internet : www.compleware.com
Email : info@compleware.com
Contact Person : John Weiler