With many clinical trial sites restricting on-campus visits due to the COVID-19 pandemic, traditional monitoring has changed. CROs must have a planned remote monitoring option as part of their portfolio. CROs should build a portfolio of remote access solutions and have them at the ready as both a primary strategy and an insurance policy for older monitoring designs, particularly if site access and travel doesn’t return in the way they expect. Sponsor clients will expect a remote access solution as part of a well-rounded offering; now let’s look at what that might include.

Deliverables
Because remote site access can be added to a CRO bid in a few ways, determining which way you want to execute is the first step.

Remote site access can be added to a CRO bid:
•    As part of a hybrid site monitoring plan: Distributing an Electronic Investigator Site File (eISF), as part of a traditional monitoring plan can allow sites to aggregate content in a shareable space and facilitate a shift to remote access for some of the planned site visits.
•    As part of an eTMF offering: By choosing an Electronic Trial Master File (eTMF) platform with remote site access to the eISF, remote monitoring can be “turned on” at any point in a study.
•    As part of a fully-virtual monitoring plan: Many sponsors are now seeking a fully virtual monitoring option, as Pfizer did in its COVID-19 vaccine trials. This means offering a dedicated remote regulatory and source content monitoring tool, in conjunction with remote IP management, eConsent, eCOA and other tools.

Data
To scope a remote site access offering as part of your bid, you’ll need to ask a few key questions:
1.    What regulatory agency will be approving the intervention? Different agencies have different requirements. Partnering with a technology vendor who can help you navigate compliance requirements is critical.
2.    How many sites are planned? Remote site programs are primarily priced based on how many sites are served so this data will help you to determine overall cost.
3.    How many sites will offer remote EMR access? Some sites will offer easy direct access to their Electronic Medical Records (EMRs) for source data verification (SDV), but others will require the use of a HIPAA and Privacy-Shield compliant source repository. High quality eISFs vendors should accommodate remote SDV needs.

Potential objections
Compiling a list of objections you may face will help you to develop a strong argument for a remote site access platform.

These are the most common objections in the industry:

1.    Site Adoption: “What if sites refuse to adopt the new technology?”
There’s often a desire to make a complete swap from in-person monitoring to a wholly virtual strategy, but because every study and research site is different, comprehensive remote monitoring coverage may not be possible, and that’s ok. Before selecting a vendor, evaluate their acceptance rate at sites to increase your consistency with remote processes.

2.    Cost: “Another software tool that I have to pay for?”
Well, yes, but in our new world, the overall monitoring budget actually decreases. Travel costs will be radically reduced, and traditional paper document storage is no longer required. In other words, the cost of new remote monitoring tools can be offset by reduced travel and document storage costs.

3.    Site Burden and Support: “Aren’t we asking more of sites and won’t we, as a CRO, have to support their technology adoption?”
Unlike a shared drive like Box.net or Dropbox, a real eISF has form and signature tools that reduce site burden. Real eISF tools let sites create study content once in the app and then have it available for remote access—this eliminates the burdensome duplicate work of creating documents on paper and then scanning them in. CROs should select an eISF vendor that manages all site training and support so that a new burden isn’t placed on CRAs, either.

What next?
Are you a CRO ready to start bidding with a remote monitoring capability? If yes, your next step is to begin evaluating eISF + Remote Access vendors to assess their platform and support capabilities as well as assessing the technology infrastructure of your existing network.