Sofpromed, a full-service Clinical Research Organization (CRO), specializes in oncology, managing clinical trials across the globe from phase I-IV to observational studies.

Based in Palma, Mallorca, Spain, and founded in 2012, Sofpromed is a close-knit team of 35 employees divided into two departments—clinical operations and biometrics. Together, they manage about 30 to 35 clinical trials worldwide with varying levels of service each year. And thanks to Viedoc, they’ve simplified their workflow, making it possible to quickly and efficiently provide data management solutions to their clients. 

Sofpromed does it all—from site selection to medical writing and more—so they can manage an entire clinical study for sponsors. They also assist with regulatory submissions, onsite monitoring, and statistical programming, among other services. Sofpromed considers Viedoc’s EDC system essential to their operations to handle such a wide range of services.

We sat down with Patricio Ledesma, general manager and founder of Sofpromed, to learn how they’re streamlining clinical trial management worldwide with the help of Viedoc’s easy-to-use and intuitive interface.  

A need for clinical trial support—and a solution

Patricio founded the company while working at a hospital in Mallorca, where he supported a medical oncologist and telemedicine projects, including clinical trials. When he saw the number of clinical trials, and thus, the hospital’s workload, growing at an accelerated pace, he decided to create Sofpromed.

Around a year ago, the team at Sofpromed realized their need for a new EDC solution. After assessing five EDC system manufacturers and evaluating the pros and cons of each vendor, they decided to go with Viedoc. When asked what defines a quality EDC system and what he gained with Viedoc, Patricio said:

- Simplicity and clarity for the user—that is a key aspect. It has to be easy to use. The less training the user needs to get used to it, the better. And, of course, the functionality and power to solve the challenges of the trial. 

Patricio’s favorite thing about Viedoc is its design and ease of use for Sofpromed’s data managers. He details:

- They have learned how to build eCRFs very quickly, which has permitted us to shorten our delivery times when we have to provide the system to our client. So, in a matter of a few days, we are capable of building the system.

Accessing critical data and reports—anywhere, anytime

Sofpromed provides clinical trial management solutions for biotechnology and pharmaceutical companies globally across multiple therapeutic areas with particular expertise in oncology.

Since the CRO mainly specializes in oncology, this means they need to implement special forms and screens that allow for easy access to radiological images and data—such as information about the tumor size, the tumor response (RECIST and Choi), and the progression of the cancer—from different workstations.

- We have been able to do that quite easily with Viedoc. In addition, we have a specific need for central reviewers of the oncologic trials—for example, a central radiologist that will review the DICOM imaging—and Viedoc offers the possibility of uploading and downloading these images as well. It’s a good solution in oncology trials assessing solid tumors.

Using Viedoc has also allowed Sofpromed to collect previous tumor treatments from the patient’s medical history and make it easily accessible for reviewers, even remotely. And with Viedoc Me, the clinical trial process is more straightforward for patients. 

- I think it comes at the right time, as I said, because the demand for remote patient-reported outcomes is growing (for example, pain, analgesic use, and quality of life questionnaires). So, it looks like a simple solution to me. It can be implemented easily, making it possible for patients to provide the data easily without having to strive with complex tools. 

With Viedoc Me, clinical trial participants input data themselves on their smartphone, tablet, or computer, allowing quicker data entry and reducing the risk of transcription errors. It’s also possible to set up auto-reminders to ensure participants report their data in time.

In the wake of the COVID-19 pandemic, this kind of solution is more vital than ever. Viedoc Connect makes it easy to facilitate the eConsent process, conduct pre-screening and recruitment, and enable remote follow-up visits.

- We can see a clear trend to empower the patient, so clinical trials can become more patient-centered.

Better systems, better services 

- I will emphasize that Viedoc is a great solution for academic trials because it is a powerful tool, yet the price is very competitive, making it ideal for academic sponsors like cooperative research groups in oncology across Europe. 

As Sofpromed quickly grows, Viedoc’s innovative and ever-changing offerings can facilitate substantial future changes. Patricio counts on Viedoc to streamline their workflow, which means more time to provide a close service for their clients and respond and tackle problems promptly. That is what makes a good CRO, regardless of size, Patricio explains.