webLIMS.com is pleased to offer hosted (SaaS based) Clinical Trial Software
Professional Open Source, Software as a Service (SaaS) for Clinical Research.
LabLynx, Inc. is pleased to announce the addition of OpenClinica as part of our growing suite of webLIMS.com, SaaS solutions. OpenClinica is clinical trials software for electronic data capture (EDC) and clinical data management (CDM). Because OpenClinica is Open Source, there is no per user license or subscription fees. Simply a low monthly, unlimited users hosting fee with the security and assurances of the webLIMS Cloud Computing, Data Center.
See a demonstration video of the OpenClinica Software at LiMS.tv.
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Primary application modules include:
- Manage Study: Facilitates configuration and management of clinical trial protocols, sites, CRFs, users and study event definitions. 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, electronic data submission, and data validation.
- Extract Data: Enables definition, filtering, and extraction of study datasets.
- Administer System: Allows overall system oversight, auditing, configuration, user account management, and reporting by administrators.
Some key features of OpenClinica include:
- 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.
- Extensive interfaces for data query and retrieval across subjects, time, and clinical parameters, with dataset export in common file formats such as tab-delimited, SPSS, and CDISC ODM XML.
- Enables compliance with regulatory guidelines such as 21 CFR Part 11. Features include differentiated user roles and privileges, password and user authentication security, electronic signatures, SSL encryption, de-identification of Protected Health Information (PHI), and comprehensive auditing to record and monitor access and data changes.
- A robust and scalable technology infrastructure developed using the Java J2EE framework interoperable with relational databases including PostgreSQL (open source) and Oracle 10G, to support the needs of the clinical research enterprise.
To learn more contact LabLynx, Inc. at 770-859-1992 x109 or email us at: sales@lablynx.com
