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Friday, July 19, 2024

OpenClinica - Enabling Automated Clinical Research

Clinical trials are becoming more decentralized. Though there are new technologies for decentralized trials many of them lack the functionality needed. Whereas Covid-19 created the need for businesses to push clinical trials and faster clinical trials became a necessity. Facilitating these unique clinical trial requirements of the healthcare space is OpenClinica—a company that is transforming healthcare through innovative cloud technology that simplifies running clinical trials. OpenClinica is used across a wide spectrum of clinical research, including drug, device, and diagnostic trials, global health studies involving 200,000 patients, adaptive platform trials, and clinical trials for some of the first gene therapies to be approved for market. It enables seamless and automated clinical trial management through user experiences created workflows that empower users and increase the level of integration and automation. OpenClinica transforms clinical research through a unified, core electronic data capture (EDC) platform that simplifies the process of running clinical trials in the cloud. “At OpenClinica, we offer a platform with intuitive user experiences as well as a dynamically configurable logic for workflows and integration to eliminate duplication of data entry. This way clinical trial management becomes seamless,” begins Cal Collins, Co-Founder, and CEO, OpenClinica.

Proven in over 10,000 studies worldwide, the OpenClinica platform is trusted by leading biopharmaceutical companies, contract research organizations, academic institutions, and government agencies. OpenClinica also built out and evaluated a model for electronic health records to transcribe abstract data to the research space which is an incredible space of time and error in clinical trials. “The ultimate goal is about helping researchers to get better data faster. We offer a set of different solutions that help do that like trying to data capture, which is core of our platform,” adds Collins.

The March Towards Greater Integration

At OpenClinica, the team believes that delivering Clinical trial innovations is all about the march towards greater integration and research of care and the way it can benefit both. The company’s solutions are crafted to remove waste from the system, increase quality from both ends, and provide more value back from the care side back to the patient. “We spend a lot of time making sure the patient is central to what we do. With OpenClinica there is a lot more power for patients to share information whether it’s their electronic health records or whether it’s from devices or questionnaires. Our tools tap into those capabilities. We think by bringing it closer to patients, providing them more information about what’s going on, giving them more control and what information is shared,” explains Collins.

In a nutshell, OpenClinica makes clinical trials easy and fast. There are many ways that the company adopts what creates that strong user experience. It all starts with the company’s unique profile about understanding users, trials are complex and go through different domains. The team strives to build experiences that are optimized to give clients the right value and to build tools that are easily configurable to every given trial. OpenClinica has also formed a product team that is highly committed and capable of simplifying the processes for its customers. “We have features like auto-save, real-time execution. The ability to provide data back to the end-user whether that’s visualizations provided in real-time or automation and reminders” points out Jackie Brusch, Director of Marketing, OpenClinica.

Another aspect that makes OpenClinica stand out is its capability to combine the core data captured by systems and data management technology with the integration into the clinical world through HR integration. The company’s solution enables research customers to effectively engage with the patients as well. “Participate is an integrated part of our solution, when you build rules for workflows or reminders, have all the data in one place so data happening on another end is fully automated,” adds Jackie.

A Unified Platform

Started open source, it is within the DNA of OpenClinica to be community-oriented and be highly transparent with users and stakeholders to make things better and evaluate the needs. The company performs it on different levels, from using the platform to getting service and support teams.

What OpenClinica offer is the rigor and depth of experience and the functionality of doing clinical trials for over a decade. The team has been able to achieve this because they spend so much time listening to its customers to empower them to understand what they can do to streamline their workflows, add value, and eliminate effort and activities that aren’t adding value.  The company is also able to combine that core data capture and data management technology with the integration into the clinical world through HR integration.

OpenClinica also has a breadth of modules and functionality and it’s powered by a common framework that has logic and rules. The client’s data will be available in one place to start and can create workflows and logic that the work in real-time is tailored to each end-user again. “We also have our most popular module around open clinic insight, a reporting and open visualization tool, which is a dashboard to share information with a study team,” says Jackie. “To share what’s happening and what needs to be looked at.” In addition, OpenClinica’s innovation capabilities enable clients to integrate their systems into the OpenClinica platform and orchestrate it with the clinical trial management system.

Removing Inefficiencies and Removing Impediments

Founded in 2004, OpenClinica has always been about removing inefficiencies and removing impediments while researching to make sure quality reached higher levels. The company is a leader in moving from double data entry models and later launched the pro-participate model, the first solution that adopted the BYOD model.

Since opening its doors, OpenClinica has been a pioneer in delivering innovative clinical trial solutions and streamlining the way clinical trials work. The team works closely with its customers and developed partnerships to offer the most cutting-edge clinical trial solution available today.

Hundreds of small, midsize, and large research organizations leverage OpenClinica to capture better clinical data faster and to do so in a way that meets the highest standards for security and regulatory compliance (21 CFR Part 11, Annex 11, GDPR, HIPAA).  The company has also launched its newest product which is an electronic health record solution that makes the complex work of clinical trials easy.

OpenClinica doubled in size last year and is excited about its growth in 2022 and beyond. That’s been the result of many years of hard work, particularly dating back to 4-5 years ago when the team started building out the OpenClinica platform. “Right now, we are making investments across the board about the breadth and capabilities of our products and services. Some of our highlights are Unite, we have an aggressive roadmap to continue expanding. Complimentary to that we will be bringing tech related to patient-directed data share, that’s an exciting and empowering way to get data faster in research,” concludes Collins.


Cal Collins, Co-Founder and CEO

Jackie Brusch, Director of Marketing


“We spend a lot of time making sure the patient is central to what we do. With OpenClinica there is a lot more power for patients to share information whether it’s their electronic health record or whether it’s from devices or questionnaires”


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