A CRO managing orthopedic and medical device studies across Latin America

Dataclinic CRO is a contract research organisation specialised in medical devices, based in the United States and Latin America (Colombia). It conducts orthopedic and medical device studies, including hip and knee replacement, spine implants, and trauma-related conditions, across Latin America, mainly on behalf of sponsors based in Europe and the United States. Since most of these sponsors are not based in the region themselves, Dataclinic CRO’s main impact lies in the local representation it provides. Claudia Mejia, CEO of Dataclinic CRO, oversees all active projects directly and has worked with ResearchManager for four to five years.

Before ResearchManager, Claudia relied on an EDC provider to build and manage her eCRFs. Each new form meant sending specifications in a Word document to the provider’s team, where two or three people were involved in building it. If a correction was needed or if she wanted to test an idea, it required sending a detailed email. It would take days for them to make a change, and then more time to test whether it worked as intended, because the correction went through the same multi-person process again. Sometimes it even took weeks.

“It was just a waste of time for me,” she says.

That tedious back-and-forth made her realise she needed direct control over the EDC and a much more efficient, agile solution.

Leaving that cumbersome, multi-person process behind, Claudia based her decision to move to ResearchManager on two factors: the flexibility to build and manage her own eCRFs without approval from several people, and how she was treated during the conversations that led up to that decision.

“I can create these eCRFs myself. I have the liberty to make changes, or just to train myself and the people that would use the platform as data entries. I think it’s a reason of simplicity,” she explains.

The communication with her account manager mattered just as much.

“The way people treat you, the way people make you feel, and the way people present their project, their company, their idea, that was also very important,” she says.

“That interview I had with Thierry was really motivating, because I felt that I was really in contact with someone that could tell me the straightforward answers and give me really what I needed from the system. With the other experiences I had, I had to talk to two, three different people, each person doing something different.”

Beyond that personal connection, testing the platform before committing mattered as well: compared with other EDC systems she had used, she found ResearchManager very easy, friendly, and intuitive.

Claudia experienced the onboarding as smooth. Thierry pointed her to the ResearchManager help pages, and training was offered, but Claudia didn’t need it:

“It was so easy, so friendly, so intuitive, so straightforward that I didn’t need to have a training.”

Building her own eCRFs took some initial practice, mainly working out how to structure chapters and subchapters, but she calls it “just a matter of practice.” She now trains her own team and site staff directly, about 30 minutes per person, using a short walkthrough video she made herself. She says she has never had a single complaint from anyone she’s trained.

“I’m working right now in a project in Argentina, in a hospital that is a huge university hospital, so they have a lot of students and they have a lot of clinical research. And they have told me that this is the easiest system they have worked with,” she says. The hospital has experience with other established systems, including RedCap. “They work with many of the big names, and they tell me this is so easy,” she adds.

“All my expectations with ResearchManager have been met,” Claudia says.

Her main requirement, the flexibility to work without needing approval from multiple people, has been fulfilled, and questions are typically answered within a day, whether through the help page or customer service. Additionally, the platform does what it’s supposed to do.

“I’ve never had a bug in the system,” she mentions. “I’ve always been able to extract the information whenever I have needed it.”

She keeps no separate backups of her study data. In four to five years of use, she’s never had reason to worry about losing it.

Independence that saves time

Four to five years on, the flexibility Claudia sought remains in place: she still builds and manages her own studies across several Latin American countries without needing anyone else’s sign-off. She still reaps the benefits of that today. Building an eCRF, a process that used to take weeks, now takes her only two to three days.

A differentiator in client services

Building and managing her own eCRFs within the EDC has changed how Dataclinic CRO works with clients.

It has shaped how Claudia presents her services. “That freedom allowed me to really get to understand, get to manage and use the system, and offer it to my clients,” she says. “Now it’s one of the main points of my customer offer, that I have the EDC system to create the eCRF models for them.”

It has also changed the first interaction with a new client. Claudia is now able to present a functional draft of the eCRF within the first week following the kickoff meeting, a level of speed that would not be possible without full autonomy to build the eCRF herself.

“Being able to offer an EDC system that is efficient, secure, user-friendly, and fully managed in-house gives clients immediate confidence,” she says. “That speed and flexibility have become key differentiators for Dataclinic CRO, and a decisive factor for clients choosing to work with us.”

Claudia has already recommended ResearchManager to surgeons she previously worked with, who were looking for a similar system for their hospital. Asked what makes her recommend it, she sums it up simply:

“It’s an interface that is intuitive, it’s simple, it’s efficient, it’s comfortable, it’s safe, it’s reliable.”