Advancing Data Management and Monitoring – Change the Game With Integrated eSource/EMR/EDC

Explore Clinical Research IO (CRIO)’s integrated eSource/electronic medical record (EMR)/electronic data capture (EDC) model, where source data is collected electronically by the site using CRIO’s eSource system. This data is transmitted automatically to CRIO’s Reviewer module or to legacy EDC systems, which allows sponsors to review, query, code, lock and extract the data. By eliminating source data verification, data transcription errors by the sites and enabling real-time, continuous access to site data, this data management and monitoring model unlocks significant savings for the sponsor/clinical research organization (CRO).

In the traditional EDC model, clinical research sites collect source data — which is the data collected contemporaneously with the protocol-prescribed procedures — and transcribe it into the electronic case report forms (eCRF) housed in an EDC system provisioned by the sponsor. This transcription is not contemporaneous and can lag weeks and even months. The source data is reviewed, and source data verified (SDV) directly by the Clinical Research Associates (CRAs). The EDC data is then reviewed and queried by the Data Managers.

In CRIO, there is only one template, not two — the source and the eCRF are one and the same. This single data collection template is built by the sponsor/CRO for publication to the sites. The eSource template is written in a site-friendly manner, similar to the way sites are used to capturing data. To this end, CRIO has developed a study design guide explaining the way CRIO’s eSource templates should be configured, and how the design approach differs from more traditional eCRF approaches. Once published to a site, the site cannot edit the core template, but may add site-specific custom procedures or questions on top — thus accommodating potential differences in workflow across sites.

Register for this webinar to learn how sponsors and CROs can take advantage of the efficiencies provided by integrated eSource data management and monitoring systems.

Speakers

Raymond Nomizu, CEO & Co-Founder, Clinical Research IO (CRIO)

Raymond Nomizu is the Co-Founder and CEO at CRIO, an e-clinical provider for sponsors, clinical research organizations (CROs) and sites. CRIO’s system allows research sites to collect data accurately and contemporaneously, and sponsors to view the data in real-time, without costly source data verification. Prior to founding CRIO, Raymond owned and operated an independent clinical research site, co-founded a real estate data analytics firm called Bench Core (later sold), and served as a Management Consultant both independently and as a Principal for The Boston Consulting Group. He has over 10 years experience consulting senior management across multiple industries on issues of business strategy and process improvement. Raymond has AB and JD degrees from Harvard University.

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Stephen Boccardo, Senior Vice President of Sales, Clinical Research IO (CRIO)

Stephen Boccardo, Senior Vice President of Sales at CRIO, brings 25 years of sales and leadership experience to CRIO. Most recently he served as Senior Vice President of Business Development and Commercial Strategy for Quartesian, a contract research organization (CRO) with deep data management capabilities. Prior to that, he served as Chief Commercial Officer for Clinical Ink and Senior Vice President of Business Development for Bioclinica, where he led the e-clinical sales team.

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