ADDITIONAL SOFTWARE

Simplified Clinical Trial Data Management

Software should simplify clinical trial data management from the moment you decide to incorporate it into your program. For that reason, our technologies interface seamlessly and are tailored to fit your program from the ground up. We make it easy to manage electronic case report forms (eCRF), electronic patient reported outcomes (ePRO), spirometry data, radiological images, electrocardiogram (ECG) data and more. To equip your trial with complete and versatile software solutions — rely on CompleWare.

Click on the links below to learn more about our additional software solutions.

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WebCDL®

WebCDL® gives your investigators and high-level personnel the power to oversee and manage research data. Custom monitoring and review tools aggregate all physiological and laboratory device data — including spirometry, spirometry challenge, electrocardiogram (ECG), pulse oximetry, blood pressure, height, weight and point-of-care laboratory data, as well as radiological images — to facilitate more rapid review and sign-off.

WebCDL®:

  • Generates and imports queries electronically into ClinDataLink® to eliminate paper and data transcription
  • Allows for paperless queries
  • Employs one application for multiple protocols
  • Permits investigators to review and sign data online
  • Enables online data management
  • Is 21 CFR Part 11-compliant for electronic records
WebCRF®

WebCRF® allows for easy entry of your case report form (CRF) data and makes them available online 24/7 on one integrated Web-based platform. WebCRF provides monitoring and management capabilities that empower clinical trials to be completed more rapidly than other data collection methods allow.

WebCRF®:

  • Uses the WebCRF administrator tool (WAT) to define and administer virtually any CRF with full validation and informative flags (requires no custom programming)
  • Integrates, manages and provides review of all clinical trial data with ease
  • Generates multiple online reports to track study progress and metrics
  • Allows data to be entered and validated, and databases to be locked, much more rapidly than other data capture methods
  • Eliminates the need for virtually all manual double-entry
  • Allows multilingual data entry into a single database
  • Includes an easy-to-navigate user interface, even when performing complex, real-time edit checks
  • Is 21 CFR Part 11-compliant
WebEPRO®

WebEPRO® enables electronic patient reported outcomes data (PRO) (diaries, quality of life measures and other PRO endpoints/questionnaires) to be collected via Web and/or interactive voice response systems (IVRS). With WebEPRO, your subjects easily submit data from home or wherever Web access is available, and you review results in real time.

WebEPRO®:

  • Uses an administrative tool to define protocols, which means it does not require any custom programming, allowing for rapid setup (one to two weeks)
  • Is platform-independent — compatible with Web, PDA, telephone, IVRS and scannable forms
  • Uses CompleWare unified user logon
  • Generates reports and study metrics to track study progress online
  • Includes an easy-to-navigate user interface, even when performing complex, real-time edit checks
  • Is 21 CFR Part 11-compliant
ClinDataLink®

ClinDataLink® gives your sites the ability to easily manage and upload physiological study data captured by devices (i.e., spirometry, electrocardiogram, pulse oximetry, blood pressure, height, weight and point-of-care laboratory data). Paired with WebCDL®, your personnel have immediate and unobstructed access to your data.

ClinDataLink®:

  • Offers exceptional data capture and management
  • Uses one application for multiple protocols (minimal site footprint)
  • Defines each clinical study protocol using a protocol wizard
  • Exports data to a central Web server where results are viewed online and queries can be generated (WebCDL)
  • Automates error checking and data validation
  • Eliminates paper queries, faxes and telephone logs
  • Simultaneously creates a source document entry and a case report form (CRF) entry electronically
  • Is 21 CFR Part 11-compliant
HomeCDL™

HomeCDL™ simply collects your subjects’ spirometry and diary data, as well as other patient reported outcomes (PRO) data. Custom data forwarding options ensure safe, confidential and flexible reporting.

HomeCDL™:

  • Captures subject spirometry and diary data into the same devices when away from the clinic
  • Transmits data using a variety of data transmission modes including wireless technology, modem/phone and Internet transfer
  • Uses devices including PDAs and pen tablets
  • Decreases time to data lock and controls costs
  • Allows online access to other integrated clinical trial data
  • Captures electrocardiogram (ECG), case report form (CRF) and other physiological data
  • Generates multiple reports to track study progress and metrics
  • Is 21 CFR Part 11-compliant
RandomizeIT®

RandomizeIT® supports accurate patient enrollment, screening, randomization and termination in clinical trials by Web or phone, while also acting as a user portal to permit site data entry. Sponsors and monitors can access enrollment logs and randomization data online 24/7.

RandomizeIT® enables sponsors to:

  • Track study metrics (including visit date and disposition codes)
  • Distribute medication and laboratory kits to sites based on enrollment
  • Pay sites based on up-to-date study logs, which may enhance subject recruitment
  • Use CompleWare’s unified user logon
  • Send randomization confirmations via email and/or fax
  • Conduct 21 CFR Part 11-compliant research
ScanCRF®

ScanCRF® is the best choice for fast, accurate, cost-effective and user-friendly paper case report form (CRF) data capture. Using forms designed and printed by CompleWare, CRF data can be scanned into a secure database using CardReader software. CompleWare has provided CRFs that can be scanned and read by optical mark readers.

SymptomScoreCardII®

SymptomScoreCardII® offers rapid, accurate and cost-effective paper diary data capture. On-site SymptomScoreCardII allows subjects to score their symptoms, which are entered into a secure database almost immediately. This technology is particularly suited for studies in which subjects are monitored as they enter diary data, such as "allergy park studies" or studies at sports venues.

SymptomPhoneLink®

SymptomPhoneLink® provides interactive voice response (IVR) technology for the capture of diary data. Subjects participating in a clinical trial use phones to enter symptom data directly into a computer database by responding to digitized voice prompts.

IVR technology reinforces the tracking of protocol compliance and ensures diary data entry is performed on the proper date and at specified times. The digitized prompts may use the investigator’s voice and may be recorded in any language or multiple languages. Online data are available 24/7 to qualified sponsor personnel, allowing up-to-date monitoring and analysis of study conduct.

crfWorldLink®

crfWorldLink® is a Web-based application for collecting global clinical research data. With just a Web browser, users are connected to real-time data in CompleWare’s cloud-based database. crfWorldLink is custom-programmed to meet sponsor or other end-user requirements. Unlike solutions such as WebCRF®, crfWorldLink is not a form generator program and cannot be programmed rapidly. crfWorldLink is used in cases where there are unique application requirements that cannot be met by using an off-the-shelf application such as WebCRF®.

GenuineSourceDoc®

CompleWare creates source documents that are used to capture data on paper or electronically. These state-of-the-art source documents enhance the ability to monitor studies and to lock databases rapidly.