Clinical Trial Monitoring is an essential element of the clinical trial process and a vital connection between the Sponsor/CRO and the Research Site. Monitoring is the Sponsor/CRO’s obligation to ensure that the Research Site conducts the trial per the protocol, SOPs, GCP, and any other regulatory requirements.

Ultimately, when conducting an IND trial, regulations require the Sponsor/CRO to ensure the:

  • Rights and safety of patients are protected
  • Reported trial data is accurate, complete, and verifiable from source documents
  • Conduct of the trial is in compliance with the protocol, Good Clinical Practice (GCP), and applicable regulatory requirements

Monitor/CRA Challenges

As the complexity and number of clinical trials grow, Monitors and CRAs tasked with site monitoring face increasing pressure from regulatory demands requiring near real-time site oversight and sponsor expectations for more timely data exchange.

Demand for this site connectivity has been increasing to solve this challenge, with 32% of Sponsors/CROs saying digital site connections are their top priority for the next three years. In response, software vendors serving the Sponsor/CRO market have deployed “sponsor-first” software platforms, known as “site-portals,” to Research Sites. These platforms place the Sponsor/CRO at the center of the ecosystem and generally add little value to the research site, even adding to their workload as they must now work with up to 50 different Sponsor/CRO deployed portals.

The fact that Sponsors/CROs need more direct site connectivity isn’t changing – it is the only way to accelerate research while lowering development costs. However, the trend in connectivity is shifting the focus from sponsor-first solutions to integrating with site-first solutions.

Key to this shift is integrating Sponsor/CRO tools, like the eTMF, to purpose-built Research Site based infrastructure such as the eISF. This “site-first” model provides the sites the tools they need to get work done, while also enabling real-time connectivity back to the sponsor.

Florence is pioneering this model of connectivity by giving Sponsors/CROs a single point of connection to the research sites through Florence eHub. Florence eHub directly integrates the Sponsor/CRO eTMF platform with the Site eISF.

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Understanding the Electronic Investigator Site File (eISF)

The Electronic Investigator Site File (eISF) is rapidly maturing at Research Sites. Florence projects that by 2022 over 90% of United State Research Sites managing more than ten current studies, and a growing percentage of International Sites, will have a majority of their research-related documents and data in an eISF.

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Benefits of the eISF for Clinical Trial Monitoring

Accessing and managing a study within an eISF is accompanied with numerous benefits associated with Clinical Trial Monitoring. These advantages are made apparent for both Sponsors/CRO’s and Research Sites involved in the study. Sponsor/CRO Site Monitor Visits fall into four distinct types and relate to the stage of the trial. Site Evaluation Visits (SEV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Closeout Site Visits (COV) can all benefit from utilizing an eISF.

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