At CRIO, we’re more than “just the tech guys.” In our Q&A series, Ask Me Anything, we caught up with Stephen Boccardo, Senior Vice President of Sales at CRIO. Stephen has been involved in the life sciences industry for over 35 years and has conducted thousands of conversations around the unique needs of industry leaders. Today, particularly in a post-pandemic world, life science companies on the brink of innovation are more open than ever to embracing new approaches to conducting clinical research. In this Q&A, Stephen discusses his perspectives on sourcing the best technology vendors and what’s next in clinical trial technology.
What should sponsors and sites look for when choosing a vendor?
Sponsors should look for vendors who can demonstrate industry experience, are responsive, and provide timely input for questions and queries. Vendors ought to be transparent about their capabilities early in the process, and provide accurate estimations on timelines and deliverables. Collaborating with vendors that produce realistic timelines will avoid many issues downstream. Avoid vendors that say they can do it all. Another hallmark of a strong vendor is one who will challenge sponsors on their requests and provide domain expertise to the situation. Ultimately, sponsors need to look for vendors that become trusted partners and share the same values that they do as they conduct clinical research.
What problems do you hear from life science companies and how does CRIO help solve those issues?
In many of my conversations with sponsors, they’re looking for ways to conduct decentralized trials, gain greater efficiencies, expand access to more diversified patient populations, and reduce timelines. This could involve patients entering data directly from their phone or through wearable devices, so the data comes directly from the patient into the clinical trial database. Sponsors often complain about the cost and lack of flexibility in finding the best decentralized clinical trial vendors and service providers for their unique needs. I’ve heard for many years that it has taken way too long to get clinical trial data back to sponsors. And the process is costly. Costs can include: onsite monitoring, data querying, reviewing, coding, and verifying transcription. All are complicated processes that can take a lot of time.
What differentiates CRIO’s product from anything else on the market?
CRIO is approaching the process of capturing clinical trial data differently. CRIO’s system is a holistic platform designed for clinical trial workflow processes at the site – no other system was designed with this workflow in mind. The current process includes multiple steps before the data gets to a sponsor for review, cleaning and analysis. Typically, sites enter data, at the initial point of entry, into a paper source or other systems that are not designed for clinical trials, such as an EMR or EHR system. That data is then re-typed into an EDC system at a later date. CRIO eliminates duplicitous data entry into EDC and provides a single platform for sites to use during patient visits. CRIO’s eSource technology has been adopted by over 1,000 global sites which use the system to capture patient visit data. Validations, edits checks, cross-form queries and reminders happen in real-time. These are designed to guide sites in data entry. That data is immediately made available to sponsors for review. This enables remote monitoring, real-time data management review, query and coding. This also allows for more up-to-date safety review and trend analysis. Entering data only once into CRIO, and repurposing the data for review and analysis, is a fundamentally different process than what has been used by the industry for the past 50 years.
Can CRIO support fully virtual decentralized clinical trials? If so, how?
Absolutely. CRIO is doing that right now. We are conducting a fully virtual, decentralized trial, without physical sites, where patients are being eConsented remotely. Visits are conducted by a virtual PI through telehealth, which is integrated directly into CRIO’s eSource system. We are also conducting Clinician Reported Observations (ClinRO) through the CRIO system. Additionally, notifications are sent out for patients to download and use electronic Patient Reported Outcomes(ePRO), where patients/subjects can enter data using their own device. All of the data is being consolidated in CRIO’s Reviewer database, where sponsors can review and analyze site reported data, patient reported data (ePRO), and wearable data.
Do you have any advice for life science companies running clinical trials?
While clinical trial technology has evolved over the last 25 years, there has not been that much advancement in the process of running a trial. By embracing the technologies that are available today, you can apply them to the process, while maintaining regulatory and PHI requirements. Three trends that are here to stay are eSource, DCTs and home healthcare models. eSource is certainly advancing the process of how data can be captured and reused during a clinical trial. DCTs bring clinical trials to patients anywhere and will be a driver in increasing patient diversity in future trials. Mobile nurses capturing data at a patient’s home or on a tablet will also be key to expanding access for people to participate in clinical trials. The industry will one day fully embrace that they can provide multiple modalities (at sites, at home, wearables and ePRO) to get more patients involved in clinical trials, drive more diverse clinical trials, and support trials where data can be captured in different ways.