On the 22nd of April, jointly with our partner Agatha Inc. we have conducted a webinar titled “Effective Remote Monitoring: Process, Project, and Technology”.
In the first part of this webinar, we discussed a holistic approach to remote monitoring – from the requisite definition of the right tool to integrate it into the technology ecosystem of your company.
In the second part of the webinar, we gave an overview of Agatha Remote Monitoring & Quality Control for Sites and learned about its benefits and advantages. We concluded the webinar with a Q&A session with the speakers – and we got so many of them, that we decided to turn them into a blog.
Continue reading to discover the questions from the Q&A session from the webinar.
Who should be responsible for a remote monitoring solution – the sponsor/CRO or a site?
Agatha Inc: Sponsors benefit from putting in place a remote monitoring application due to two factors:
- Lower legal and compliance risks. For example, a sponsor has the responsibility of ensuring that the patients involved in a study have correctly filled in, and signed the “Informed Consent” forms prior to their participation in a study. Those forms confirm that patients understand and accept the risk of participating in a study. Those forms must be signed before a patient starts taking the drug to avoid legal and compliance risks. It is often not possible for a sponsor to consistently check the informed consent forms in time, and instead, the review is typically done too late when the sponsor staff (the CRA) periodically visits the clinical sites.
- Optimised costs, as the CRAs onsite visits are limited.
However, we have also frequently seen clinical sites setting up remote access to their eISF to sponsor. This is especially true for large sites that are already using Agatha eISF to manage their site documents. In that case, they would share a subset of their site documents with the sponsor for a limited period of time. It is not common from our experience that a site would only set up an electronic system only to share documents with monitors. This is most of the time part of a larger initiative to manage all of their site documents.
How do Agatha’s applications integrate (eTMF and the Remote ISF)?
Agatha Inc: This is very simple! When a document is ready for monitoring review in the eISF workspace, the CRA can access it and perform a QC check on the document. If the QC check is rejected, the document goes back to the site staff for review. If the QC check is approved, the document can then be sent to the TMF (from the document action menu). At that stage, the document is added to the TMF at the right location (based on the TMF artifact classification).
How much SOPs should be rewritten in order to move to remote monitoring system?
Arithmos: It depends on the certified quality system that you already have in place. The amount of effort that you need to invest in SOP update depends on how the SOPs are written, the number of details, the reference to Working Instructions and templates. In any case, the references to the regulation, the new technologies adopted and the processes must be updated.
If I am going to transition to a Remote Monitoring and Governance model, how do I start? Should I start with 1 study and all the sites associated with that study?
Agatha Inc: It depends on the size of your organisation. We can recommend the best approach based on the context. Some examples of what our clients have done successfully:
- Medical Device with 20 (small) studies. Roll out to ~20 sites on 2 studies during 2 months, and expand to all sites later on. Then roll out the Post Market Survey process later on.
- Sponsor with ~50 studies and 20 CRAs. Roll out to 40 studies initially (for first 2 to 3 months) and expand to 100 sites during year 1, 200 in year 2, and 600 in year 3. Agatha is used to reviewing informed consent remotely.
What happens to the site’s ISF when the study is completed? Is there an archive option?
Agatha Inc: There are two options:
- Export the eISF. Agatha allows for admins to export all of the information (files, audit log, metadata) in one click, and receive an archive to download.
- Keep the eISF in Agatha. Agatha offers an option to lock down the study and archive it. In that case, it is only possible to read information. Modification is no longer possible.
We recommend keeping the information in Agatha to facilitate audits and searching for historical information.
Should I already have all my documents in digital form to move to remote monitoring?
Arithmos: It is not obligatory. However, adopting a remote monitoring model should be part of a bigger Digital Transformation process that also includes digitalisation of the documents. Learn more about building your Digital Transformation strategy from our webinar “Digital Transformation in Pharma: Challenges and Enablers” available on demand.
It is possible to integrate the system with EDC? How can a monitor verify the source documents?
Agatha Inc: Yes, Agatha offers a comprehensive REST API to integrate with external systems including EDC systems.
Is it possible to upload word or pdf document and sign it with an electronic signature? For example CVs.
Agatha Inc: Yes, Agatha supports CFR 21 Part 11 compliant signatures.
Would you rather recommend a hosted solution or cloud solution for remote monitoring?
Arithmos: You would need to decide this based on the size of your company and the strategy you use for technological development and updating.
You might decide to implement an on premise solution, if your company is already equipped with a data center, a sufficiently structured IT department that already manages most of the hosted tools and is willing to bear the costs of IT staff upgrades, security, upgrades, and migrations.
However, if you are following a strategy that foresees a huge use of SaaS, Cloud tools, with a light IT department and need to be ready to upscale quickly, we believe the right choice is a SaaS cloud solution.
Do you have any questions about moving to remote monitoring model that you did not manage to ask during the webinar? Contact us to talk to our experts!