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One of KAI's strengths includes its data management expertise. KAI staff have implemented software applications such as our web based Electronic data capture (EDC) system, OpenClinica 3.1 Enterprise©™.
This EDC not only supports remote data capture but has study management and sophisticated reporting capabilities. This system provides an easy to master interface that reflects the logical progression of a clinical trial. OpenClinica allows for real-time and batch query generation while also provides for dynamic management of query resolution process. Reports generated from OpenClinica’s database can be posted directly to a secure Web portal for review on a need to know basis or printed at the sites or by the sponsor. OpenClinica can also be used for studies relying on paper CRFs. OpenClinica 3.1 Enterprise©™ complies with 21 CFR 11 requirements, has a 508 compliant user interface and has been certified to be CDISC compatible.
Start up does not require extensive programmer involvement. Project managers can create eCRFs by filling out an Excel like template which is transformed into database tables, Web pages for entering data and real time and batch edits. This straight forward approach to application development is efficient and cost effective. Studies can go from protocol to deployment in a matter of days. In the past 2 years, KAI has supported 100s of studies conducted at domestic and international sites sponsored by both industry and NIH.
OpenClinica Enterprise©™ interfaces with the KAI interactive voice recognition system (IVRS) for use in treatment assignment and has the capability of coding adverse events and concomitant medications. As part of the KAI clinical trial suit OpenClinica 3.1 Enterprise©™ works with Smart Trial©™ our Clinical Trial management system that helps manage all regulatory, administrative, financial and logistical tasks required by a study.
KAI is an active CDISC member and has made use of common data elements (CDISC, CDASH, agency or corporate specific data elements) that data standards can facilitate study start up and allow the storage of an organization’s completed study data into an accessible data warehouse. Data warehouses provide the opportunity for aggregate data exploration and analyses. Please refer to Data Warehousing section of the website for more information on our data warehousing capabilities.
KAI statistical team makes use of SAS, StatXact and SPSS for data analysis. Our PhD and Masters level statisticians develop statistical analysis plans, study design (including adaptive clinical trials), randomization method (block, adaptive, simple and minimization) and final analysis and participate in writing the INDs, NDAs and the clinical study report (see SAS and Statistical fact sheet).
Fact Sheet
Clinical Trial System Suite
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