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Paperless Trials - RBM

The future of clinical trials and monitoring

  • e-Certified Source Documents
  • Identify site issues faster
  • Deliver enhanced control and quality

Overview

Paperless trials (PT) provide greater flexibility for the sites, sponsors and CRO's conducting clinical trials. PT significantly reduce time and costs as compared to trials conducted in a traditional electronic manner as simple source document verification (SDV) in replaced with a higher value source document review (SDR). PT require seamlessly integrated technology solutions ensuring inclusivity, enabling all stakeholders their secure, respective workflows. This expands the system to multi-dimensional stakeholders (all user groups), as where traditional paper systems based and EDC systems normally accommodate bi-dimensional stakeholders (Sponsor/CRO).

Sites, Sponsors and Service Providers (CRO's, IRB's, Labs, Drug Supply) all benefit from the use of Paperless trials. Data is not only instantly accessed globally, but the audit trail enables document lifecycles to be established tracked, and maintained. Individuals and organizations are empowered, as they no longer have to rely on sending multiple emails, phone calls, or fax's to secure information in order to perform their job function.

Risk Based Monitoring (RBM) plans can be easily implemented due to system adaptability, with 24x7 accesses to electronic completion guidelines, and escalation procedures. The most sophisticated RBM plans can be confidently implemented, ensuring quality, accuracy and time/cost reductions.

On site/Remote monitoring reports can be easily filled out using both a combination of automated data population/aggregation from the system, as well monitor input. Electronic monitoring reports within the system are immediately available, converting them into actionable reports that can assist the site, service provider and sponsor ensuring timely decisions, resulting in superior study conduct.

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