Automate, When the Value is There
We don’t just automate everything but do so strategically by collaborating with sponsors to determine what is important. We start with a key question: what required processes are tedious or prone to human error? It makes sense to automate them. Automation is about helping everyone save time by letting “the machine” handle simple and frequent tasks. The benefits are many: we reduce errors, focus on what’s most important, do more with less, and above all mitigate costs–in time, money, and opportunity. For example, the time spent on aggregating monitoring metrics was reduced by 99% and limited potential errors to near zero.
Our PMs serve as study “hubs”, sharing information cross-functionally with both internal and external team members, driving cross-functional real-time dashboard reporting. These tools allow us to support virtual clinical trial (VCT) management. Data-informed, agile, and scalable, ARG Operations sees ourselves as the operational arm of the sponsor there to realize collective goals.
Automation Runs Throughout the Whole Company
ARG’s individual contributors serve as domain experts because they fully understand their function’s current processes. Rather than turning over automation work to IT, ARG team members are active partners, creating workflow diagrams and documenting processes and tasks. Once the automation is initially put in place, individuals help with testing, quality control, and validation. ARG team members work directly with technology partners individually or collectively to create and maintain integrations and automations. The sponsor benefits because ARG team members are not siloed working on one specific task; rather, the knowledge transfers that take place throughout the organization nurture curiosity, problem-solving, and ownership of studies.
Streamline and Optimize the Project Review Process
Study data comes in from various platform sources. At a monthly internal review, we bring all of that valuable information into one place, scrutinizing it to make sure we are on track and on time. For sponsors, this means access to clear current data in a dashboard to facilitate project oversight. The ARG process supplies data (and with it status updates) essentially without asking for it. In the traditional model, it would take 130 minutes daily to request and download all form data from Medrio to Google Drive for all studies; now the downloads can run in parallel in 1 minute total. This is an integration and automation in a real-project example that pays dividends in project review.
Embrace New Ways to Collaborate
ARG IT facilitates smooth communication flow and data transfer between internal teams, sites, sponsors, and other stakeholders. Tools and apps such as Zoom, Google Hangouts Meet and WebEx have always been part of culture, so when things change in the industry and world, we are able to maintain normal operations. ARG incorporates remote monitoring of clinical trial data in the Electronic Data Capture (EDC) system to perform source data verification (SDV). To facilitate remote monitoring for data that is not directly incorporated into the patient’s EMR, we have added fields to the EDC or have rolled out Veeva’s SiteVault so that sites can upload a scanned document, pdf file or even a photograph of data reports. We recognize that telemedicine is becoming increasingly important in the healthcare industry and have updated trial-specific EDC systems to allow a site to upload recorded telemedicine sessions as well.
Continually Identify Opportunities for Iterative Improvement
The ARG IT team is infused with a culture of looking at new ways to do their jobs all of the time. We identify opportunities for improvement in smaller processes, operational areas, and repeatable activities. After, we incrementally improve our approach and execution through versioning and testing. The sponsor benefits from our flexibility and ingenuity because by constantly tweaking efficiencies, we are doing required and expected tasks faster and better, and we are able to spend time working in critical areas of projects.