Sunday, February 01, 2015

Electronic Data Capture


Every study is unique. Whether your study requirements demand a data management solution to manage complex global clinical trials or simple data collection, ClinArt International brings comprehensive EDC solutions to capture, clean and analyze real-time data across a variety of EDC applications.


Our EDC solutions include Oracle® Clinical, a robust and easy-to-navigate system to collect and report real-time data for large-scale, global clinical trials, and eClinArt®, a customizable trial management and adjudication system for expeditious review of safety and endpoint-driven data from medium to large-scale clinical trials or registries. In addition, ClinArt International has established working relationships and experience with leading third-party EDC providers.


Our web-based solutions manage single or multi-site clinical research studies. It facilitates protocol configuration, design of electronic Case Report Forms (eCRFs), Electronic Data Capture (EDC), data extraction, and data management. Our solutions support HIPAA, Title 21 CFR Part 11 and other regulatory guidelines, and are designed as a standards-based extensible, modular and open source platform.


Main Features:
  • Manage Study: Facilitates configuration and management of studies (protocols), sites, CRFs, users and study event definitions by study directors and coordinators. You can define data elements, CRFs, and protocol events without any custom programming.
  • Submit Data: Provides a user-friendly web-based interface for subject enrollment, data submission and validation. For use by clinicians and research associates involved in patient enrollment and data capture processes.
  • Extract Data: Enables data extraction and filtering of datasets for use by investigators, statisticians, and study directors.
  • Administer System: Allows overall system oversight, auditing, configuration, user account management, and reporting by administrators.
  • Organization of clinical research by study protocol and site, each with its own set of authorized users, subjects, study event definitions, and CRFs. Support for sharing resources across studies in a secure and transparent manner.
  • Dynamic generation of web-based CRFs for electronic data capture via user-defined clinical parameters and validation logic specified in portable Excel templates.
  • Management of longitudinal data for complex and recurring patient visits.
  • Data import/export tools for migration of clinical datasets in SAS, SPSS, CSV, Excel spreadsheets, local databases and legacy data formats.
  • Extensive interfaces for data query and retrieval, across subjects, time, and clinical parameters, with dataset export in common statistical analysis formats.
  • Compliance with HIPAA privacy and security guidelines including Title 21 CFR Part 11 and  use of study-specific user roles and privileges, SSL encryption, de-identification of Protected Health Information (PHI), and auditing to monitor access and changes by users.


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