Clinical Research IO (CRIO), a website and android application that allows sites to replace paper with tablet-based data collection has launched. Users can access a library of pre-populated, best-practice source templates that are customizable to meet the needs of their own protocols.
As owner and executive director of a site in Quincy, Massachusetts, Raymond Nomizu often found himself frustrated with the inefficiency of having to record source data on paper.
“It was frustrating for a number of reasons,” he said. “It led to quality control issues. We would have checklists and templates, but there was no guarantee that people would fill them in properly and not make mistakes. And there was no easy way for me to QA the source data.”
Nomizu also realized that there wasn’t a good solution out there for clinical research sites that was designed to capture data electronically.
“A lot of these software systems are built for sponsors,” Nomizu said. “But [these systems] start with a sort of data definition of what they are trying to accomplish, which is obviously important. So they are built around the data.”
What this means, Nomizu said, is that the typical clinical research site’s IT needs, particularly as they relate to workflow, have not been met. With that in mind, Nomizu and his partner, Phuc Truong, a self-described internet entrepreneur from the Boston area, tried to fill that void.
“Our challenge was to build something that was very useable, scalable and–very important for most research sites–affordable,” said Nomizu. The result was CRIO.
“We built CRIO around the workflow needs of research sites,” said Nomizu. “We have to collect good, clear data, and it’s really important that the people collecting the data have a tool that really meshes with their workflow. If it doesn’t, there are going to be issued.”
How will it help workflow? In a paper-based process, collecting height and weight data and converting that to BMI would involve going to a website to use a BMI calculator, Nomizu said. “And you may or may not remember what the limit is for the study. Now [with CRIO], we just capture height and weight, it calculates the BMI and tells you right away whether it’s exclusionary or not.”
Another example is informed consent version tracking. “In our system, when you upload a new informed consent and you version tag it, it keeps track of who has executed that version,” Nomizu explained. “So the next time a patient comes in and they haven’t executed that version, an alert pops up. That allows us to keep track of re-consents, which is something that is really easy to miss.”
The system also provides user-specific alerts. Take, for example, questioning a patient on his or her smoking history. “If the answer is yes, it will tell you to ask a particular series of questions,” Nomizu said.
This conditional logic–the idea that an answer to a question may or may not lead to other questions–is a key to streamlining workflow, Nomizu said. “It’s all automated in our system, which means that we are only collecting the data that is needed–nothing more and nothing less.”
According to Nomizu, about 10 clinical research sites have gone–or are about to go–online with the system. One such site is Medvin Clinical Research, a multi-specialty, multi-facility research company based in the Los Angeles area.
Vipul Vineet, Medvin’s research director, said his company has decided to use this solution for a number of reasons. First, he said the traditional method of maintaining paper documents is both “expensive and tedious,” particularly considering that clinical trials records and data need to be retained for a minimum of 15 years.
“If you think about the amount of paper that’s generated through the course of a study, and maintain that through 15 years, the costs really add up,” said Vineet. “Now we can maintain 25 or 30 different studies on a single flash drive. And that flash drive will cost you $15 compared to a storage facility that’s going to cost you $200 a month.”
Another benefit to the system is the ability to access it remotely, said Vineet. “That’s definitely the case with me since I have four different sites to manage,” he pointed out. “If a clarification is needed at one of the sites, and I’m not there, I can’t get it done on time. But if it’s available remotely, I can access it anywhere.”
CRIO also makes the data available and easily accessible to site monitors, which is important since the size, complexity and increasing number of clinical sites means that complete on-site monitoring is becoming more ineffective, inefficient, and expensive. “The trend for monitors to go on-site has been changing and they don’t come as much,” said Vineet. “They used to come on an eight-week basis, and now it’s 12 weeks. In this case, [monitors] don’t even have to come every 12 weeks–they could come every six months and they are still able to access the data from their homes or their offices, make comments, ask for clarifications and get it done in real-time.”
As for the future, Nomizu said he hopes to have about 20 sites go live with the system by the end of the year. “Ideally, we would like to be a platform for research sites to use our system for everything they need to do in one place,” he said. “From recruiting patients, to scheduling, to collecting data and having one place to centrally manage their portfolio. But the main thing is to get the data and get it done right. That’s our vision.”