What makes a clinical trials software provider a good fit? How do you make the decision to use a particular electronic data capture (EDC) system or electronic patient reported outcome (ePRO) solution? These are important questions, and the answers are different for every sponsor and contract research organization (CRO). Recently, we sat down with one of our newer customers to hear why Medrio is their clinical trials software and services solution of choice.
OncoBay Clinical is a for-profit subsidiary of Moffitt Cancer Center that focuses on early-phase oncology. As a boutique CRO, they offer custom solutions that support biopharma and biotech companies from “concept to clinic.” (Click here to learn more about OncoBay)
They have been with Medrio for almost two years, partnering with us when their company was less than a year old. They build the use of Medrio ePRO and EDC into many of their proposals. “I’m a big fan [of Medrio]. I know how easy it is to work with, how easy it is to clean and get data out of,” says Melanie Marshall, OncoBay Senior Manager of Data Operations. “Our bid defense is introducing the platform to potential clients.”
“For one thing, it’s super easy to build. It doesn’t take back-end programming. It has a drag and drop design that’s really attractive,” explains Marshall. “To me that speeds the build quite a bit, and it makes it very intuitive. Because when you’re building a database, it’s important to think about the people who are going to be using it.”
Medrio ePRO makes tracking patient reported outcomes easier while introducing data quality assurance. “I think that patient feedback is much better than having a paper diary. For example, ePRO can give [participants] reminders and is patient-reported. I think it speaks a lot more to the integrity of the data itself. Because if there’s a timestamp, there’s an audit trail. So, we know when the patient did something, and we know when they logged this [adverse event] for themselves or marked this dose.”
OncoBay is growing as a CRO organization. The pace is fast, and resources can be tight at times. They needed a clinical trials services company that goes beyond software. “Medrio is very responsive. The teams are professional, but they still act like a partner, not as a vendor,” explains Marshall. “I don’t have to manage anyone.”
“You know, when it comes to Medrio, I don’t even know how big the organization is because I’m lucky enough to get to speak to the same people over and over again… I like knowing that if I have an issue and I don’t know who to talk to, I can ask our designated Customer Success Manager who can help with this.”
OncoBay COO Dannelle Palmer believes that many smaller, oncology focused organizations try to make phase I and phase II as simple as possible, but reducing complexity and cost upfront can actually lead to spending more time and money later.
“Whenever we see an extensive number of surveys or anything like a dosing diary, we automatically pitch ePRO,” explains Palmer. “There is tons of data cleaning and reconciliation with paper.”
The problem is that many smaller biotechs don’t have prior experience with ePRO, says Palmer. “A lot of people at these companies have successfully used paper in prior lives, and they focus on price not cost. But the right solution pays for itself.” For example, complex dosing instructions can cause patient confusion. Some days, participants need to take two pills or fill out two surveys; other days, it is just one. “Electronic systems help with this confusion and there are fewer issues.”
“Don’t think just about the cost of adding ePRO,” explains Palmer. “As a CRO, more errors in the data may equate to a change order later to complete the work reconciling paper diaries and surveys.” Instead, think of the concept of dollars per page. Look at how many pages are in the study surveys, how often they are given, then calculate the total number of pages. When you look at the ePRO cost on a per page equivalence, there can be significant cost savings. Plus, there is the added benefit of improved data quality and time saved through electronic data collection.
“I think Medrio would be a great fit for when you need a little more nuance. Maybe a little more flexibility,” says Marshall. “For early phase oncology, you need quick build timelines, easy to design, easy to program, easy to get edit checks in place… Many sites are already familiar with Medrio, so you don’t have to go through new training.”
“The FDA wants to see your data. Everybody has the same activities. You perform data reconciliations with external data and SAEs, resolve queries, and things like that. You can use Medrio and save yourself a lot of money, save yourself a lot of time, and still get a really quality deliverable for the study because the data is the deliverable.”
Medrio ePRO and EDC deliver a better experience for patients, CROs, and sponsors. Study participants can use their own smartphones or tablets to enter their data, while investigators can access real-time data. This transparency allows researchers to respond to adverse events quickly, ensure patient adherence, and develop compliant audit trails – but don’t take our word for it (or OncoBay’s). Click here to see how Medrio ePRO works or request a demo.