Implementing an innovative technology within a clinical trial is about much, much more than the technology – and while the tech might be “disruptive,” its actual implementation shouldn’t be. Failing to anticipate and plan for operational challenges is something that has hobbled the growth of many truly innovative tech companies’ – especially those that assumed their roles began and ended with building the technology.

Mitigating these risks should be a core part of the commercial deployment of innovative technologies. This requires is a dedication to not just figuring out the technology, but figuring out how it all works in concert – and then building a nimble and effective feedback loop of continual improvements based on the realities of clinical research.

One of those realities is that study teams are inundated with new platforms to collect data, new tools for interacting with patients, new med tech for meeting protocol requirements. And every new tech, tool or platform comes with new trainings and a new processes.

While disruption sounds impressive in theory, in practice, it can be miserable.

Cognivia has been built on the belief that well-thought-out and implemented change doesn’t have to be painful – and, in fact, it shouldn’t be. That’s why Cognivia created a robust operational team charged with creating, maintaining and improving the lines of communication between the clinical teams, the data scientists, the engineers, and the sponsors. Because technology is only good as good as its ability to be operationalize effectively and efficiently. Technology should support researchers and relieve pain points, not create more.

Process Optimization for Clinical Teams

Implementing a clinical trial is already a complex, demanding, and high-pressure task. Adding the integration of new, unfamiliar technology and its associated processes only amplifies these challenges. Process optimization is paramount and not something study teams should be asked to shoulder with little to no support.

The Cognivia operational team, with its strong experience in managing trials as a sponsor, is well aware of these challenges and the importance of providing the necessary support to ensure smooth integration and execution.

Education, Training & Support

The operational team works proactively with the Sponsor project manager to make implementation as simple and easy as possible, accompanying the project all the way through study close.

We demystify the tech, proactively communicate when actions/tasks will be required, anticipate questions, coordinate training, and provide the support necessary to save them as much time and effort as possible. Training is flexible, doesn’t exceed 10 minutes, and is available as on-demand recordings should there be staff turnover over the course of a study.

Patient-centric Approach & Diversity

For disruptive technologies, success will only come with adoption by the ultimate end-user: the patients. Keeping the patients’ perspective and user experience top of mind is another key accountability for our operational team. This includes considering the diversity of the patients. Their various perceptions, backgrounds and expectations must be taken into account to keep the technology inclusive, ensuring the way the technology is implemented doesn’t limit the participation of any categories of patients.

Our patient-centric approach to both management and development means clinical teams have fewer patient objections to worry about. Targeting the ultimate user’s satisfaction enables a virtuous cycle, where adoption naturally spreads.

Although Cognivia’s platform is sophisticated technology that meets strict compliance and quality benchmarks for reliable and accurate data collection, the clinical staff and patient interfaces are designed to simplify and speed every interaction. In short, for the clinical staff and patients, it is about adding questionnaires to a study. Deployed electronically.

Clinically Informed, Quality Development

The operational team also works in tandem with the development engineers on changes and improvements to both the functionality of the technology and the interfaces.

Multidisciplinary Skills

Our software and data mining development teams are composed of highly skilled engineers with diverse backgrounds in medical research and data analysis industries. This multidisciplinary expertise enables us to innovate and find the most efficient solutions for our users. The team’s past experiences bring a wealth of knowledge and unique perspectives that are crucial in developing advanced functionalities for the platform.

The operational team applies their previous experience in managing clinical trials at some of the largest pharmaceutical companies to ensure that new functionalities are not only technically sound but also aligned with the practical needs of clinical teams. With direct contact with customers, they play an essential advocate role in providing real-time feedback and valuable insights that guide future developments.

Agile

The operational team is also in direct contact with customers, providing real-time feedback and valuable insights that guide future developments. By leveraging the operational team’s direct experience with the system and customer interactions, the development team can prioritize and implement features that truly enhance user experience and operational efficiency.

Having our own platform for questionnaire administration and being autonomous in the enhancements required mean we can respond quickly and efficiently to the needs of clinical teams and patients. We are able to eliminate complex scenarios users will almost never need and keep processes as simple and straightforward as possible.

Building Bridges

The operational team at Cognivia is the connective tissue that makes all of the stakeholders function as a cohesive whole. They are project managers, listeners, advisors, support personnel, timekeepers, and collaborators, and, really, the grease that smooths the collaboration between the often-disparate teams.

They translate the scientific value to the clinical managers, the operational needs to the technical engineers, the process details to the data scientists, and so much more. They are one of Cognivia’s not-so-secret secrets to making a disruptive technology with critical added value, an intrinsic and easy to implement component of any clinical trial.