The OnTheMove Clinical Blog
What the Perfect Monitoring Visit will look like in 2030
Duncan Scattergood | | 6 minute read
Monitoring can often represent 20% of all study costs, and may be more in Phase III studies. Across the industry, this represents billions of dollars every year. Essential to ensuring data integrity and patient safety, much of this investment doesn’t directly accelerate molecule development or patient outcomes — at least not in its current form.
Rightly, sponsors want to ensure that they are getting value for money: assuring data quality, meeting regulatory obligations, and developing sites. Initiatives such as RBQM and Central Monitoring have transformed the way monitoring is performed. However, traditional site monitoring remains a key methodology and a significant driver of costs.
The Perfect Visit
At this stage, I think it is helpful to introduce the “Perfect Visit” from the Consumer Packaged Goods (CPG) industry. While healthcare is not retail, the process discipline and data-driven approach behind the CPG ‘Perfect Visit’ concept provides a valuable framework for re-imagining monitoring efficiency.
In CPG, a visit refers to a sales representative visiting a retail store on behalf of a manufacturer. Part of the visit is transactional (e.g., verifying sufficient stock and ensuring shelf placement complies with the retailer/manufacturer agreement), and part of the visit is more strategic (e.g., developing a relationship with the store manager, determining whether the location warrants additional promotional materials). Think of the “Perfect Visit” as a playbook for pre-visit, in-store, and post-visit activities, with a defined set of business objectives (such as increased sales and improved data for decision-making). Once the goals and activities are clear, manufacturers invest in tools and processes to support the Perfect Visit.
... applied to Clinical Operations
The analogy to site monitoring is clear. Like CPG store visits, a monitoring visit combines transactional checks (SDV, IP accountability, documentation review, etc.) with strategic engagement (site relationship building, performance optimization, etc.). And, in both industries, management seeks greater value from shorter visits – hence the idea of the perfect, optimized visit.
Of course, achieving the Perfect Visit is a journey, with improvement realized through multiple changes to an organization's documented SOPs.
That said, to set off in the right direction, we need to know our planned destination. In that spirit, I have developed a template for the Perfect (Interim) Visit in 2030, which respects investigator site burden, CRA workloads, and the need for inspection readiness under evolving ICH and health authority regulations. Click on the headers below to open up each section.
- Ensure maximum value from the visit
-
Adjust the on-site activity plan based on:
- Study and Site Risk Registers
- Site Performance Analytics (e.g., recruitment, query resolution)
- Regulatory document review (e.g., ethics, CVs)
- Previous Visit Report(s) and outstanding Follow Ups
- Open Issues
- Items arising from other studies at the same location or involving the same site personnel
- AI-generated recommendations from these data sources (1)
- A single planning tool that allows for fast point-and-click editing of the plan while viewing all the relevant information. Where required, enforce the recording of decision-making as to why activities are included/excluded.
- An industry standard approach for validating AI tools and ensuring privacy – a journey that is already well underway
(1) – See my separate post, “Will AI kill central monitoring?”
-
Ensure Compliance:
- Regulatory – e.g., ICH E6(R3)
- Data quality
-
Primarily Automated:
- Staff
- Essential Records
- Informed Consent
- Adverse Events
- Protocol Compliance (although there is also a relationship to SDR)
- Blinding
- Selection Criteria
- Automated tools to compare site and sponsor records
- Use AI (including processing scans of physical documents) to deal with site records in unstructured form
- CRA now performs spot checks and deals with exceptions
-
Primarily Automated:
- Blinding
- Investigational Product (manual because physical inspection is involved)
- Review with site missing documents, outstanding Follow Ups, and open Issues identified pre-visit
-
Improved CTMS data capture:
- Offline & Phone-based as CRA moves around the site
- One touch where appropriate (e.g., IP quantity confirmation)
- Ad-hoc note capture (typed and voice) for later integration
- Eliminate need for external trackers
- Discover top-level problems for the site and the study (to enable mitigation)
- Start and End of Visit Meetings
- Enrollment Review
- Source Data Review
-
Improved CTMS data capture:
- Ad-hoc note capture (typed and voice) for later integration
- Eliminate need for external trackers
- Support and encourage the site in delivering the ideal study (for the sponsor and patients)
- Start and End of Visit Meetings
- Ad-hoc training and process improvement suggestions
- Sell involvement in future studies
- Start and End of Visit Meetings
- Tools to suggest studies the CRA should be discussing
- Capture responses for feasibility teams & possibly perform site qualification activities.
- Complete regulatory actions
- Complete and Submit Monitoring Report
- Semi-automated generation of questionnaire responses and Follow Ups / Issues from captured data – dramatically reduce post-visit report write up time
- Pre-submission checks for completeness, consistency, and quality
- Complete update of internal records
- Updates to site level information – e.g. global directory
- Completion of Monitoring Report and internal site records to be one task updating two destinations
- Site monitoring to be an ongoing process rather than a set of one-off events – prevent issues before they arise
- Manage open Follow Ups and Issues
- Proactively investigate Issues / potential Issues outside of the monitoring cycle
- Respond to requests from the site
- Alerts from ongoing AI review of Clinical Operations and Clinical Data feeds
- Simple management of out of cycle tasks, including automated generation of regulatory documents (e.g., for the TMF)
- Ensure future monitoring activities are effective and proportionate
- Initiate changes to the site specific risk register and monitoring plan (schedule and activities) based on findings
- Ensure learnings are shared appropriately across other sites and studies
- Recommend changes to the study risk register
- Raise possible cross-study improvements
You will notice that SDV does not form part of my Perfect Visit. In reality, I suspect that by 2030 it will be dramatically reduced rather than eliminated, but the amount of CRA time spent on SDV will be heading towards none. I explore this further in my post “Will anyone still be doing SDV in 2035?“.
You may well want to vary some of my detailed activities, but a key takeaway is that by investing in appropriate enabling technology, we can free the CRA from spending significant time on mundane tasks such as navigating between systems, reconciling data, and writing reports. That means we can spend more time on activities that will improve future site performance, remove cost from the monitoring process, or, most likely, a combination of the two.
At OnTheMove, we’ve seen firsthand how much value is released when CRAs are equipped with the right information at the right time, and data capture is made simple. Of course, the Perfect Visit isn’t just about technology – there is a mindset evolution that is just as important. But the right technology can empower people to do the work that technology can’t.
About the author
Duncan Scattergood is Managing Director at OnTheMove Software and has worked with Clinical Trial Management Systems (CTMS) for over 10 years. OnTheMove for Veeva enhances the Site Monitoring process by presenting the CRA with the information they need, when and where they need it. This improves monitoring quality and reduces the time spent navigating multiple systems and performing report write-up.