Clinical trials continue to be burdened with paper and manual processes. Sometimes hybrid situations are used where there are some paper processes and some manual processes. Either system (all manual or hybrid) makes clinical trial documentation challenging as it is not all digitized. However, the challenges are easily overcome by implementing digital documents with workflow task automation throughout your clinical trials. By doing so, you can eliminate paper at the point of origination while reducing or eliminating the need for labor intensive processes like document printing and filing, scanning, manual tagging and classification.
To realize these benefits, BioPharma organizations are deploying collaborative cloud solutions that connect global clinical trial teams together seamlessly within a compliant, standards-based environment. Collaborative cloud portals must provide an enterprise-level solution that can do the following:
- Quickly connect teams of sponsors, CROs and investigators in a secure portal with a role-based experience, available on mobile phones, tablets and web devices
- Eliminate paper-based processes with digital signing and automated document workflows to better manage data
- Track essential document milestone completion with reporting and audit trails for compliance and quality
- Improve collaboration and document exchange capabilities to accelerate the flow of information between stakeholders
- Support standards-based technologies to facilitate interoperability with existing systems
With automated workflows, clinical trial operations can realize significant cost and time savings while realizing higher levels of clinical trial document management quality, process compliance, reporting and auditability. At the heart of this is next-generation collaborative cloud portal-based applications that can be used by all stakeholders in a clinical trial project – study sponsors, clinical research organizations, investigators, auditors and data providers. And, with an open platform, you can use the applications you want without being locked into only one vendor.
Compliant Digital Signing
A key component of a preferred solution is the ability to digitally sign and complete documents entirely in the cloud with FDA and EC compliant digital signing capabilities. By implementing such a solution, you eliminate paper at the point of origination for clinical trial operations. Cloud applications are accessible across web and mobile devices, making it possible to access them anytime, anywhere. With digital signatures and workflows, global teams can complete tasks on schedule through simple and easy to use wizard-based web portals.
By empowering the entire clinical stakeholder team with access to cloud-based portals and task completion with automated workflows, manual processes can be reduced or eliminated. As a result of task automation, enhanced clinical trial project management, comprehensive task tracking, milestone management and oversight are possible, accelerating clinical trial project completion. And, all of this makes you audit-ready. To learn more, read our white paper.