Running Clinical Trials with a Remote Workforce – SterlingBio Smart CRO Services and Solutions

Running Clinical Trials with a Remote Workforce

If you are like many organizations who have implemented or considering a work-from-home policy for the immediate term or planning a broader long-term strategy with a distributed workforce, you are not alone.  Most of us rely on productivity tools to get our jobs done, and Clinical Trials is no exception.  We are doing our part at SureClinical to support all our customers who may be newly working from home.

There are currently serious current concerns and even mandates regarding in-person meetings, and many site visits are on hold for the immediate term.  While our new reality is difficult on a personal level, managing clinical trials remotely with a modern, cloud-based platform has become more and more prevalent even before this crisis for its speed and efficiency benefits.  

Supporting remote or distributed workforces is one of the key use cases for the Cloud

Whether you are a believer in remote work or like the benefits of having a team co-located, the trend is overwhelming towards a more distributed workforce.  Clinical trial management has been on the forefront of this trend. In my role, I interface daily with our customers and overwhelmingly, what I hear they love about SureClinical is the ability to do their work anywhere, anytime and on any device.  I thought I’d share some key trends in managing clinical trials with a remote or distributed workforce and how we’re helping.

Remote Monitoring

Monitors, or Clinical Research Associates (CRA’s), often thought of as the road warriors of Clinical Trials, can and do much of their work remotely. Using an auto generated calendar to view monitoring appointments, CRA’s can keep tasks on track.  They tell us that they can easily fill out questionnaires and complete MVR using fillable forms, auto kick off review and sign workflows.

With an electronic trial master file (eTMF), CRA’s can monitor case report forms and trial master files remotely.  And if the site has an electronic ISF, they can easily compare the iSF and eTMF that they are in sync.  Better yet, if they have a unified system, such as SureISF, that comparison and syncing with their eTMF is done for them.

Manage your eTMF from Anywhere

Regardless of whether you’re a Clinical Trial Manager, Monitor, Principal Investigator, or Project Manager, you are responsible for managing a lot of documents and tasks.  If you’ve been reluctant to make the move to digital, this is the time to start.  Not only can documents be uploaded from anywhere, including straight from an email, or drag and drop, they can be automatically meta-tagged, so you can find them again easily. With a fully aligned eTMF, with clear role-based dashboards, milestones and easily creatable reports, you know where you are and what you need to do.  And, we know that beats paper and Excel.

What about all those signatures needed?

While there are huge variabilities in the number of documents per study, for conversation’s sake, let’s assume the that there is an average of 5000 documents in every study.  And, many of those documents need to be validated for their accuracy, and the integrity of the document needs to be assured.  The back and forth from sending out documents and even signing, scanning and emailing represents a large chunk of the time related to study startup.  Enter Digital Signing, which has helped many of our customers cut study startup time by more than 50%. For more details on how to ensure your signed documents are Part 11 compliant, check out last month’s blog). 

Cloud-based Operations

As mentioned earlier, remote and distributed working is a key use case for the Cloud.  You can work from anywhere if you have an internet connection and a device, even your phone. We are believers.  After all, we built our products and our platform from the ground up with zero dependence on any one location.  Our 20+ data centers around the world allow us to support you 24/7/365 with no loss of connection.

From distributed working to remote or even virtual trials, technology is the enabler.  At SureClinical, we have always taken pride in the part our software and platform plays in helping our customers bring lifesaving treatments and devices to market quickly.  Never have we been tested at this rate. We know that several of our customers are working day and night right now to try to find a COVID-19 vaccine.   If your organization is working on a vaccine or treatment now, please let us know how we can help.

We are truly facing unprecedented times that the COVID-19 virus is affecting all aspects of our lives, from being inconvenienced by quarantines, travel restrictions and school closures, to worrying about our seniors and those most at risk.  Our thoughts go out especially to those that are sick, to whom we extend our heartfelt best wishes for a quick and full recovery. Rest assured that we at SureClinical are here for you.  We’re up and running and keeping normal support hours.  Please contact us.

About the Author

Laurie Pattison has spent her career working at the intersection of people and technology.  She’s worked in technology long enough to remember Y2K, worked on one of the first B2B Cloud applications around, and spent 8 of the last 10 years working remotely. By day, you can find her responsible for Marketing for SureClinical.  On weekends, you’ll find her snowshoeing or hiking with her dogs in the beautiful Sierra Nevada mountains we’re lucky to have in SureClinical’s backyard. Connect with Laurie on LinkedIn.