Remote Site Monitoring- GCP Clinical Studeis

Remote Site Monitoring

Benefit from our e-Site’s space solution to accelerate and decentralize your clinical trial

Many of our clients have found that the Covid-19 pandemic that disrupted their clinical trials, proved that remote sites monitoring is necessary and possible. They asked for a solution. We have one.

Our solution is a powerful tool to support real-time remote quality oversight of clinical trials.

It is a complete, ready-to-use, pre-validated cloud-based solution that allows clinical sites to securely upload study participants’ source documents and study essential document, so CRAs can easily review remotely.

We invite you to rethink your traditional on-site monitoring visits and paper-based interactions with study sites. Join many others that have already moved to virtual collaboration between sponsors, CROs and sites.

Our e-Site’s space solution allows us effectively manage your clinical trial:

  • Circulate documents (e.g. protocol, Investigator Brochure, etc.) to your sites by uploading them to a public shared e-folder.
  • Conduct QC on your sites’ uploaded documents and duplicate easily to your clinical trial eTMF.
  • Conduct cost effective remote SDV/R and save travel costs.

Increasing Sites’ satisfaction and collaboration with an electronic Investigator Site File (eISF) solution

Investigator Site File (ISF) is at the core of a site’s documentation from start to clinical trial closure. ISF documentation must be complete and accessible at all times for monitoring, audits and inspections.

Poorly controlled ISF is a growing risk for both the sponsor/CRO and investigators, as inadequate record keeping is one of the most common deficiencies at investigator sites.

While Sponsors and CROs are moving towards electronic management of the essential documents on their side, leaving the sites behind with paper binders is holding back the potential for significant improvements and for streamlining the process of documents’ management.

Creating an eISF for our sites; a win-win for all

Our Sites win because they can save

  • hours of printing, copying, scanning, filing and chasing after signatures on paper.
  • space in their facility, and long-term storage costs.

Our Sponsors win because they can:

  • have full access to view each site’s relevant regulatory documents, to assure they are always audit/inspection
  • completely align eTMF and eISF.
  • save the cost of printing millions of documents for regulatory binders as well as flight and auto travel costs.

We (the CRO) win because we can:

  • start the clinical trial faster and more efficiently.
  • allow our CRAs interact with the sites remotely and identify missing documents more easily than by reviewing paper regulatory binders.

Auditor/Inspectors wins because they can conduct audits/inspections remotely from anywhere in the world, in a reduced time without the need to travel.

Offer your sites our solution. It will make their lives much easier

Sites are still dependent on their Sponsor in order to digitize their clinical trial conduct. To gain the sites satisfaction and collaboration, we have created within our eTMF platform, a separate and secure electronic space for each site to have a full control in uploading and downloading their own documents. 

Your sites will find the use of our solution is:

  • Simple
  • Flexible
  • Intuitive

Contact Us

Talk with us to explore together the workflow that will best meet yours and your sites’ needs. Let’s simply e-connect and e-share.

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