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T 32: Disrupting Clinical Trials in The Cloud





Poster Presenter

      Eric Morrie

      • ClinCapture
        United States

Objectives

This submission describes the benefits reaped by small and mid-sized biotechnology companies who adopt cloud-based eClinical systems to build, run, and manage their clinical studies.

Method

We will analyse and measure benefits of cloud-based eClinical systems in the following areas: Speed of implementation, User empowerment, Ability to scale up, or down, quickly and Lower cost of technology adoption. We will showcase the adoption of ClinCapture® by medical device or biotech companies.

Results

Speed of Implementation: With limited resources and a small clinical departments, it is critical for our users to find an easy-to-implement solution to start and manage the clinical trial process. ClinCapture has a do-it-yourself platform and intuitive drag-and-drop tools to build a study. These build tools, referred to as “studios,” allow a data manager to build a study in a matter of days, without any programming experience. Our client Providence Medical was able to build CRFs and deploy the study database in one week. The following week, they trained the sites and started collecting the data. Compared to an average 6 to 8 weeks for a database build, ClinCapture enabled this sponsor to save 4 to 6 weeks. Autonomy and user empowerment: Switching from paper to EDC requires profound changes on the organization, workflows, SOPs and forms, which are a major deterrent to adoption. For example, CRFs must be redesigned, taking into account dynamic forms and new data entry workflows. Traditional EDC systems require programming and IT skills to build a study and have a steep learning curve for all end-users. Ability to Scale: A key characteristics of the cloud is “rapid elasticity”. It refers to the ability of a cloud service to scale on demand. A mid-study size increase is seamless and doesn’t affect performance. In traditional EDC systems, there is a concern as to whether a server can handle workload increases without changing the physical infrastructure, which usually leads to delays and additional costs. Lower Cost of Adoption: By moving away from Excel files to ClinCapture, the time and cost savings were significant. DigitalizaTXT estimates 40% cost savings compared to paper and 70% time acceleration for data collection and cleaning. Another cause for cost increase using paper is the quality of the data entered on paper CRFs as there is no validation possible at the time of entry.

Conclusion

Relying on cloud-based eClinical systems empowers users while lowering the adoption barriers to traditional EDC systems. With ClinCapture, clinical trial experts now have access at no or very low cost to sophisticated features, a 21 CFR part 11 compliant EDC system, in a validated hosting environment. Clinical trials with a short timeline or low budgets, such as early phase, medical device, diagnostics, nutraceuticals, etc. can now have access to the same level of features sophistication and data quality as the bigger large pharmaceutical companies. It is necessary for sponsors to put controls in place to ensure data quality and integrity throughout their clinical trials. This can be done with paper-based clinical studies, but often with unintended negative consequences, including delays, travel costs and poor data quality. With EDC, edit checks are integrated from the start and are seamlessly activated during data entry, ensuring that the sites can address most issues as they occur. In the cloud, thanks to powerful, automated edit checks, it also results in fewer human errors and therefore higher data quality, which is one of the top performance indicators for drug developers. The ability to closely cooperate with all the stakeholders optimizes subject flow, experimental design and execution, and ultimately enhances data quality. Having access to a validated cloud-based EDC tool that requires no resource for infrastructure, maintenance and updates, allows us to focus on the business of drug development. Despite low pay-as-you-pricing models, cloud-based businesses actually generate a higher profit margin through cloud automation, multitenancy, and a lower cost of sales. Marc Benioff, the CEO of Salesforce, projected over 10 years ago that all software would be eventually deployed into the cloud. We believe the time has come for eClinical Software to make that transition.