To get more insights about clinical research technology from a vendor’s perspective, I invited Mike Wenger on the Clinical Trial Podcast.
Mike Wenger is a software developer with over 15 years of experience creating innovative solutions in clinical research.
At the Michael J. Fox Foundation for Parkinson’s Research, he worked to connect Parkinson’s patients with clinical studies.
He later developed Citeline Connect, bridging patient recruitment companies with pharmaceutical organizations, and founded VersaTrial to streamline clinical trial site workflows.
Mike is currently the Chief Innovation Officer at CRIO, an intuitive eSource solution that collects data directly at the point of patient interaction to lighten site burden while driving protocol compliance.
Please join me in welcoming Mike on the Clinical Trial Podcast.
Sponsor(s):
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 37,000 study sites, sponsors, and CROs in 90 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
This podcast is brought to you by Slope. Slope drives operational excellence for highly complex, sample-intensive, early-phase clinical trials. The platform transforms chaotic clinical trial supply chains into protocol-specific operational workflows for sponsors, CROs, clinical research sites and labs. Learn more at slopeclinical.com
SELECTED LINKS FROM THE EPISODE:
Connect with Mike Wenger
Companies: Full Stack Trials / CRIO
Michael J. Fox Parkinson’s Foundation
Hypertext Markup Language (HTML)
Customer Relationship Management (CRM)
Contract Research Organization (CRO)
Food and Drug Administration (FDA)
Key Performance Indicator (KPI)
Electronic Patient Reported Outcome (ePRO)
Institutional Review Board (IRB)
Clinical Trial Management System (CTMS)
Electronic Health Records (EHR)
Master Services Agreement (MSA)
General Data Protection Regulation (GDPR)
R: The R Project for Statistical Computing
Books Mentioned:
Comprehensive Guide to Clinical Research: Practical Handbook By Dan Sfera and Chris Sauber (Barnes and Noble, Amazon)
Zero to One by Peter Thiel (Barnes and Noble, Amazon)
Show Notes:
[0:20] Kunal Joins and Provides Background on Mike Wenger
- Software developer with 15 years of experience working on solutions for clinical research
- Worked at Michael J Fox Foundation for Parkinson’s research
- Developed Siteline Connect to help with patient recruitment activities for pharma
- Founder Versa to streamline clinical trial site workflows
- Currently founder of Full Stack Trials: Consultancy dedicated to helping clinical trial sites get the most out of their technology
[2:38] Sponsor Message: Florence Healthcare https://florencehc.com
[3:06] Mike Joins the Episode and Describes His Career to Date
- Curious person drawn to software development because it was a toolset to build things
- Found love through clinical research working at the Michael J Fox Foundation for Parkinson’s Research
- Saw research as a ‘complex industry moving science forward’
[6:46] Bridging Mike’s Love for Software Development with Clinical Research
- Clinical research is a very complex industry which creates challenging software problems
- Complexity makes innovation very difficult, leads to ambitious builders burning out and leaving after a couple of years
- Industry experience and relationships with different types of organisations help you to identify software needs in the clinical research industry
[10:02] Why is Supplier Selection and Procurement so Challenging?
- Process has multiple stake holders: vendor, procurer, and user are some of the people involved in the decision making process
- All groups have different forms of due diligence
- Procurement side includes a lot of risk and people don’t want to be the one that spent on a bad decision
- Expectation setting on both sides can be really difficult
- On site side, site is buying technology and equity from the site network is backing the purchase
- The pressure of making large purchasing decisions means people often lean into selecting large reliable vendors/services like McKinsey
[18:30] How do we convince people to take a chance on new products or technology?
- Software development functions differently to pharma development. Software can change and mature over time while other software may bring new solutions to market.
- Software can fail for various reasons: the idea wasn’t good, the tech wasn’t mature, or the project wasn’t scoped appropriately
- Hard to simulate software use case before just using it
- Medical research space is very decentralized with many different interest groups and key opinion leaders. No large organization leading best practice.
[25:22] Working with Patients in Simulated Enviornments
- Patients are amazing in terms of their advocacy and understanding of the research process
- Patients are people first and they’re very engaged with their disease. They can be very helpful in identifying problems with your solution
- Important that patients are paired with the right type of study experience for them
- Consent requirements add to the complexity of simulated research
[27:09] Various Perspectives on Bid Proposals
- Fulfilling to be a supplier or a vendor cause you have a ‘build mindset’
- Threat of competition drives you to push yourself
- Buying or selling the product doesn’t mean the job is done, implementation is key
- Both sides have some responsibility for a successful implementation
- Strong partnership and patience is key to implementation being done correctly
[32:41] Future Pricing of Technology
- Many different types of pricing models: by site, by patient, by study, or flat rate
- Long term commitments is ideal as a vendor
- Master Service Agreements are a great way of stabilizing your income as a vendor
[34:22] Sponsor Message: Florence Heatlhcare (https://florencehc.com/) & Calyx (calyx.ai)
[37:06] Supplier Communication and “Ghosting”
- Sometimes the people in large companies trying to make things happen realize that the decisions are ‘outside of their control’
- Important to find a ‘sherpa’ that can guide you through an organization’s process
- Timeframes for closing on a deal helpful for managing engagement and expectations
[39:34] Vendor Certifications for New Products and User Experiences
- 21 CFR Part 11 regulations can drive some requirements
- Other requirements can come out of the region the software is being used in: US, EU, or Asia
- GDPR and HIPAA compliance can also drive requirements depending on the data and use case
- It is important to not be caught by surprise by these requirements. Meeting them is proactive and can be driven through quality SOPs
- Getting input from the end user is also critical to make a quality user experience
[47:18] Defining Terminology Between CRO and CTMS
- Mike proposes that CTMS acronym is can be used to two different types of products and we as an industry need to fix that
- Pharma CTMS and Site CTMS have different functions depending on the needs of the groups
- Part of the issue with industry lack of standardization is that the process of getting into it requires people to “find it.’ Software devs don’t often have education programs geared towards working in this sector specifically
[52:07] Software Languages and Skillsets Helpful for Medical Research
- AI has helped make programming quicker and more accessible
- Tools like Cursor, Bolt, or V Zero are helpful to write and generate code
- Big change from when Mike learned by reading books at Barnes and Noble
[55:35] Data Visualization Software
- Languages like R or Python helpful for visualization
- Python is king of visualization space and also very helpful for AI developers
- ChatGPT is really helpful tool for learning and developing
[57:33] Mike’s Process for Learning
- Has to balance work/learning with family life
- Helpful to have an Idea you want to build when trying to learn something like Python not just the goal of learning Python itself
- Broadcast what you’re up to to hold yourself accountable
- Join a community of like minded people or go to events like Hackathons to learn
[1:01:23] Where are we today with technology adaptation at sites?
- Past was driven by lots of paper systems; these have moved to being predominantly electronic
- Added technology has increased complexity for the responsibilities of research coordinators
- The division across various systems means building expertise for coordinators is difficult when compared to software devs or other roles that are more focused on specific systems
- Lots of room for future optimization and streamlining of these processes
[1:06:25] What can People Do to Expand Opportunities at Sites?
- Compare yourself to your peer technologies to see what gaps exist that you can fill
- Analyze adjacent technologies to see how you can expand horizontally or integrate with other technology partners
- Approach trials how developers approach being ‘full stack’
[1:09:06] Patient Databases and EMR/EHR Vendors
- Mike previously worked at Athena Health EMR
- Athena one of the first groups to go Cloud and first groups to build an API
- Oracle, acquired by Cerner, are launch a group up separate product from Cerner that is an AI powered EMR
- Epic is also a large player
- For Site CTMS: CRIO, RealTime CTMS Clinical Conductor, Oncore and Velos CTMS are recent successful products
- Site struggle with the CTMS integration piece due to staff and role complexities
- eISF: Electronic Investigator Site File: Florence Healthcare is a successful vendor in this space
[1:09:06] Case Report Management Systems
- CRMs live outside of clinical research and can have broader applications: Salesforce is an example
- Integration between CRM and CTMS is very helpful for research applications
[1:17:31] Patient Databases
- EHR systems hold patient data
- Sites also have separate databases for patient recruitment of specific communities
- Sometimes databases can be sponsor driven through social media campaigns to get patient groups together
- Sometimes database can also be built out of clinical research call centers
[1:27:24] Sponsor Message: Calyx (calyx.ai)
Major Themes:
- In the last few decades clinical research has seen significant advances in the software tools and technology, but the industry still has work to do harmonizing these tools to work well together supporting best research practices.
- The clinical research space is full of complex problems that are attractive to software developers and ‘builders’ who want to innovate. Lack of clear pathways to entering this industry from non-clinical roles is a barrier for entry and contributes to burnout.
- The process of vendor selection and purchasing has numerous stakeholders. It is important to identify key stakeholders and have a collaborative plan of action to make a deal and provide a service with meaningful impact.
Quotes:
- The champion within the pharma is like your Sherpa. You’re the vendor, and you’re just trying to help get to the top of the mountain with the Sherpa helping you. I have a lot of admiration, respect for folks who are Sherpas within large companies.
- So the day to day of being a very proficient Research Coordinator takes a lot of time to build up that muscle memory and that skill set, and how do you do in a way that is productive, proficient is not super stressful, so that you can put your best foot forward on every study that you’re working on.
- Over the past, during my tenure, I’ve seen a lot of really energized builders enter the space, and I’ve seen them sadly leave a year or two later when they’ve struggled to get going. And I would say that some of the challenges, you know, it makes sense that they’re never going to go away, but the challenges are, there’s a lot of different stakeholders.
Audience Questions:
How do you feel about the current landscape of clinical research tools and technology? What are some of your current research challenges and what tools would you like to see in the future?
