The TheraScan service web-enables clinical trial documentation, management and monitoring. With a flexible structure and a sensitivity to 21 CFR Part 11, ICH E6 and HIPAA; TheraScan puts the last pieces of study-based documentation safely on the Internet.
TheraScan creates certified copies of clinical trial documents. Scans of paper originals, EHR screen captures, existing electronic files, images or other type of documents needed for clinical trials are certified as an exact copy and stored, along with document-specific data elements, in a HIPAA-compliant repository. This highly flexible infrastructure enables a wide range of possibilities for use in clinical trials.
Certified copy of Electronic Health Record screen
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Coupled with a suite of tools to interface with existing external systems, TheraScan is the solution to complete a tightly integrated, Internet-based, clinical trial.
TheraScan aims to complement rather than replace existing systems; whether EDC, CTMS, accounting, manufacturing, EHR or otherwise. This allows organizations to leverage existing technologies to solve the “trilemma” of:
- Speed: TheraScan trials can offer instantaneous tracking and monitoring of the data flow. Systemic problems are identified earlier in the process to allow for timely resolution. Information, once located in remote locations, is accurately collected in a central repository that is securely available over the Internet in an instant. Properly structured studies can close almost immediately after data collection concludes.
- Quality: Monitors, sponsors and investigators can see, at a glance, where the study stands. Communication is structured, interactions are tracked and management is solidified. Essential documents and facets of the Trial Master File can be managed centrally.
- Cost: Site visits are greatly reduced with online monitoring. Data entry and analysis can be centralized eliminating duplication of resources in the field. Monitors now concentrate site visits on building relationships and solving problems, rather than working alone in a back room. Sites are also relieved of the responsibility to oversee monitors to ensure patient confidentiality.
TheraScan uses a cloud-based architecture which greatly simplifies the implementation of the system. The client runs in a browser. The only feature that requires installation on the client enables direct control of a TWAIN scanner from within the browser. Clients have an option for a distributed document repository.
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