<img height="1" width="1" style="display:none;" alt="" src="https://dc.ads.linkedin.com/collect/?pid=437588&amp;fmt=gif">
REQUEST DEMO
Hero_BG1-01

 

 

 

 

1Asset 13x

 

Remote Monitoring. We've been at it for 5 years

In 2015, Protocol First (P1) developed a unique solution for uploading source data for industry-sponsored trials, specifically complex, interventional trials. This Source Upload solution is

HIPAA/GCP/Part 11-Compliant. 

The P1 solution was not specifically developed to support remote clinical monitoring during a pandemic. Yet, it is the right tool to cope with the current situation and the ensuing aftermath. 

LET'S TALK

MW-DF967_emerge_ZG_20150220095239

A significant logjam of monitoring visits is forming. "Shelter in Place” and travel restrictions are severely impacting the ability to review clinical trial data.

"Sites could upload certified copies of source records to a sponsor-controlled electronic system or other cloud-based repository that contains appropriate security controls."

FDA

Asset 2@3x

Solution


Protocol First’s Source Upload product, which runs (on a different screen) alongside any EDC system (e.g., Rave, InForm, Medrio, IBM, etc.) allows site coordinators to upload unredacted source data, at the click of a button. Remote monitoring made simple. Keep your trials running.

Screenshots-1

The CRA/monitor can remote monitor the data, mark it as reviewed, issue queries to the site, and download metrics reports for management, CTMS or eTMF.  

Only Monitors/ CRAs have access to view the uploaded source. They can mark the data as reviewed or issue a query to the site for clarification. The system generates metrics reports, which can be downloaded or retrieved via our API. You can thus document your monitoring activities in your CTMS or eTMF. 

 

Asset 21-1

How It Works

We take your protocol and CRFs and configure a “Source Upload” view of the data, following the visit schedule. The system provides guidance to the site regarding what source data to upload for a given visit or down to a specific procedure. You can also offer source upload data for key logs (e.g., ConMeds, Medical History and AEs).

You can always complete monitoring when things return to normal. But when will that be? Partial and focused remote monitoring will allow you to keep your trial moving and return to normal faster.

Only Monitors/ CRAs have access to view the uploaded source and they can mark the data as reviewed. Our system can then produce a report of what CRFs have been reviewed. The information can also be retrieved via our API.

LET'S TALK 

Beat_AML

Source Upload has been in Production for 4 years and is used in registrational and interventional research in the US, Canada and EU. Among others, our system is used on Beat AML (Beat AML® Master Trial For Healthcare Professionals).  Beat AML needed the ability to remote monitor source data, due to the inherent complexity of running upwards of 11 simultaneous trials, at over 15 major academic institutions. Safety reviews and critical dose-escalation decisions could not wait!

 

P1 Source Upload Numbers

20 Sponsors

250 Protocol Versions

400,000 Source Pages

photo-1488590528505-98d2b5aba04b

Loading PHI data into an EDC system is a big no-no. If source data is uploaded into the EDC, all PHI must be redacted which is tedious, time- intensive and error-prone!  Yet, redacted data are not source documents and require re-monitoring!

“Data subject to remote source data verification are likely to require re-monitoring, in particular if it was based on pseudonymised documents, which cannot be considered as source documents.”

EMA

Asset 1@3x

Data Access Problems


Obstacle 1 -- Legacy EDC Problem: While a few EDC systems allow Direct Data Entry as “eSource”, none allow the unredacted source to be uploaded.  In other words, the site coordinator needs to black out every piece of PHI and it’s very easy to miss some patient identifiers.


Obstacle 2 -- Remote EHR Gateway Access: Some institutions allow remote access to their EHR.  It is both a serious administrative headache for the site to review and grant/revoke access to their EHR and many leading academic institutions simply refuse to grant access.


Case Studies


Multiple sponsors have been using our system for 4+ years. For example, on Beat AML® Beat AML® Master Trial For Healthcare Professionals. For more information, here’s an article that was recently published by Clinical Leader:Clinical Operations In The Age Of A Pandemic

photo-1523292562811-8fa7962a78c8

FDA-01

Coping with COVID-19

The National Institute of Health (NIH) and the Food and Drug Administration (FDA)  have published guidelines likely to affect all industry-sponsored trials.

LET'S TALK


Asset 2@3x-9

Guidance

 


"It will be important to capture specific information in the case report form that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information."

Reference


  • Limiting study visits to those needed for participant safety and critical care  
  • Conducting virtual study visits
  • Arranging flexibilities for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics

Outside Labs

To make sure you offer local treatment and basic safety review for your subjects, you may allow them to see their local clinic or hospital. How are you going to collect your key safety lab data? How are you going to collect your key safety laboratory data?


Remote Visits

To make sure you offer local treatment and basic safety review for your subjects, you may allow them to see their local clinic or hospital. How are you going to collect your key data elements? 


Patient Guidance

You may want your site to reach out to your subjects and give them guidance regarding COVID-19. How do you collect that information from the phone interview?

Asset 3@3x

Regulatory

Our entire infrastructure is HIPAA-compliant and we have undergone multiple audits from leading academic institutions. The site user uploads a “certified copy of source”, which is recognized by ICH/ GCP guidelines and truly allows remote monitoring.  

Asset 13x

5 Days. Go-live.

Asset 47@3x

 

It typically takes 3-5 days to build an eProtocol and eSource system. As you can imagine, demand is especially high right now, so please let me know the soonest you can be available for a quick introductory call.

LET'S TALK