Tools for risk-based monitoring

Netsourcing tools

firefox-gray One of the greatest expenses in clinical trials is the cost of managing sites, especially when a trial is spread over many sites and/or great distances. The cost of a single site visit can run well into four figures. Therapeias’ netsourcing offers the opportunity to move many site duties to a central location providing much better control, greater productivity at the site and lower costs for the sponsor.

Remote source document verification (rSDV): Our patented system to create network-accessible certified source-document copies relieves the clinical monitor/auditor from having to go on site to view physical copies of source documents. Instead, source-document verification can be done at a centralized location using images of the paper documents created using the TheraScan system – which uses a standard personal computer, document scanner and smart-card reader. This is at a cost near that of a standard photocopy or facsimile.

Electronic files can also be copied and certified with the TheraScan system. This opens the possibility of certifying output from imaging systems, web archives from EMR systems or clinical flowsheets retained as spreadsheets.

Study documentation repository: Sponsors need to confirm that study documentation is collected and up to date. By making certified copies of such documentation as informed consents, IRB approvals and curricula vitae sponsors can easily confirm that such requirements are met in a timely and efficient manner.

Remote data entry: Therapeias can abstract data from case reports forms (CRFs) and other source documents into a clinical study management system. By using the TheraScan scanner interface, highly legible copies are sent to a centralized site. Specially-trained Therapeias staff then uses a combination of technologies to extract the relevant data from these submissions. Therapeias uses barcode reading, optical character recognition and constrained handwriting recognition to automatically extract much of the information. We then use our in-house system to do double-entry verification to ensure the highest accuracy of the resultant data. The data is then either delivered as an extract suitable for uploading into the client system, or incrementally added to the study database via a “database link”. Turnaround for this service is generally less than 24 hours from submission to uploading.

Randomization: Using a sponsored-supplied randomization scheme, Therapeias can return randomization information to the site immediately when a patient is consented and/or enrolled. This can be prompted by the submission of either an informed consent or an initial visit CRF.

Electronic protocol: The study protocol can be uploaded to the study web site within the Therapeias system. Once the protocol is uploaded, subsequent amendments can later be added to the repository. This offers a centralized resource so the current protocol is available to all sites without the danger of sites not keeping their printed protocol current. In addition, the TheraScan system maintains a version history of previous protocols so that a historical record is maintained.

Remote environmental monitoring: Therapeias can integrate the management of environmental controls such that sponsors can monitor such things as temperature, humidity and access. This information is collected automatically with the added ability to send alerts via SMS message or email when reported values fall out of range.

Benefits: When information is processed quickly, and added to the study database in near real time, monitors and auditors are able to identify systemic issues early in the process and rectify them before they become major issues.

Also, when such responsibilities as data entry, document storage and retrieval and record keeping are either accomplished or managed centrally, clinical personnel are freed to do the work they are trained for. This allows medical professionals to concentrate on what they are trained for, while the important but non-clinical work is transferred to staff that are the most efficient for these duties. The result is a more efficient study operation, with high quality data and a greatly reduced cost.