Tools for risk-based monitoring

Netsourcing tools

firefox-gray One of the greatest expenses in clinical trials is the cost of monitoring 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 tools offer the opportunity to move many site monitoring duties to a central location providing for much better control, greater productivity and lower costs. Study staff can also use the system to better manage/control the workflow of the clinical trial.

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 and document scanner. 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/screen shots from EMR systems, or clinical flowsheets retained as spreadsheets. When combined with an EDC system, network-accessible source documents greatly simplify risk-based monitoring by having the source documents available concurrently with EDC data. EDC systems do not require customization in order to incorporate rSDV into the process.

Essential Documents (eBinders) Essential Documents have traditionally been maintained in physical binders for patients, staff and sites in a clinical trial. Using the TheraScan system sites may now upload these documents to the repository. The resultant organized files may be quickly accessed by both site staff and monitors to confirm the completeness and content of the files.

Trial Master File (eTMF) Sponsors need to confirm that study documentation is collected and up to date. The TheraScan system supports the collection and organization of documents needed for the Trial Master File. This includes study-wide documents, site-specific documents, site “override” documents and client-specified documents. Documents are saved for submission and are also sharable across the study so the items like protocols and SOPs can easily be accessed.

Remote data entry (rEDC) Therapeias can abstract data from case reports forms (CRFs) and other source documents into a Electronic Data Capture system. By using the TheraScan interface, highly legible copies are sent to a centralized site. Specially-trained Therapeias staff then use 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 for double-entry verification to ensure the highest accuracy of the resultant data. The data, including the source document link, 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.

Investigation Product (eProduct) Using document uploads, RFID technology, plus the TheraScan eMail interface, The manufacture, shipping and inventory of the Investigational Product may be easily and seamlessly monitored, at the item level, from a central site.

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.

Proactive Whenever a record is added to the TheraScan system, a client-specific trigger is activated. This allows for such processes as prompting a purchase order from the accounting system for a newly enrolled patient, alerting the medical director of a Severe Adverse Event or an alert to study staff of a change to the protocol or SOPs.

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.