Digital signatures enable organizations to go paperless and create secure and compliant source electronic records that can be verified for signer identity and intent, and data integrity by anyone – today or years into the future. Digitally-signed electronic records are portable, self-contained, sustainable, and compliant with worldwide regulations. As a result, they provide legally enforceable electronic records that are recognized by sponsor organizations and regulatory authorities. As such, organizations that implement digital signatures benefit from expedited business processes and significant cost reduction, while maintaining legal and regulatory compliance.
As pharmaceutical companies face intense financial pressures due to looming patent expirations on blockbuster drugs, as well as weak drug pipelines and heightened competition, they are implementing strategies and technologies that can improve operational efficiencies in clinical trials and speed drugs to market. One business process seeing the most scrutiny is the clinical site start-up phase, which can take months to complete before the first patient is enrolled and visit scheduled.
Over the past decade companies have invested in e-Clinical technologies aimed at speeding up site initiation. For example, Clinical Trial Management Systems (CTMS) geared toward CROs and sponsors have provided business intelligence portals and clinical dashboards for monitoring study activities and logging key milestones. More recently, these systems have been extended to investigator sites and IRBs with investigator portal functionality, which includes secure document exchange and adoption of fully electronic Trial Master Files (TMF), as well as capabilities for completing site visit reports online.
These clinical investigator portals are yielding quicker site/study start-ups, as well as significant cost savings and other tangible benefits. However, if the electronic documentation is nothing more than scanned copies of the original source paper documents, then the total value that can be gained from these investments is not being realized.
With standard digital signatures, source documents can be signed and maintained electronically without ever introducing paper into the process. Digital signatures provide fast, efficient, and low-cost approvals. They enable secure electronic document exchange and submissions with signatures that can be verified and trusted by any receiving party, in a format that sponsors prefer for submissions to regulatory authorities.
e-Clinical Portals with integrated digital signature capabilities enable the various participants in a clinical trial (sponsors, CROs, investigators, IRBs, etc.) to sign the documents that constitute Trial Master Files or eTMF. This eliminates the delays, costs, and low-level security associated with paper-based documentation. Furthermore, since the source documents are being created, signed and distributed electronically using standard digital signatures, any party with access to the documents can verify the signer’s identity and document content integrity – inside or outside of the investigator portal. This documentation includes NDAs, financial disclosures, 1572 forms, protocols and informed consent letters, IRB approvals, trial agreements and contracts, CVs and various certifications, safety letters, drug shipment and handling forms, delegation of duties forms, and others.
Likewise, during the course of an on-going study, the clinical research associates (CRAs) monitoring the site activities can digitally sign site monitoring reports and other documentation. With the strict requirement to have these reports signed and submitted within only 10 business days, using paper-based reports with wet ink signatures and routing via priority mailing can prove to be costly and time-consuming. Using digital signatures, CRAs in the field can quickly sign site monitoring reports and electronically transmit them to the home office project manager for approval, after which the reports can be electronically submitted to the sponsor organization.
