Clinigma
Making patient focused drug development easy, correct and secure

Many factors lead to the production of a successful drug that promises to improve and even save millions of lives. And, more often than not, the processes involved in the development of a pharmaceutical product require implementing the latest IT innovations alongside advanced analytics. However, according to Jens Harald Kongsø—a longstanding expert on strategic drug development—one incredibly important aspect of the pharmaceutical product lifecycle is overlooked or mismanaged: patient insight.

“If we are going to improve modern drug development processes, we need to start listening to each patient better and incorporate their feedback,” he says. While most pharmaceutical companies claim to be patient-centred in their drug development, in reality, patient voice is sought symbolically or as customer service rather than fully analysed to understand how the drugs meaningfully impact quality of life, how the patients assess the benefits and risks, and how drug preferences are formulated. These concerns are critical to a drug’s clinical trial, and regulatory authorities such as the Food and Drug Administration (FDA), European Medicine Agency (EMA), and others have begun encouraging players in the industry to pay more attention to the voices of the patients with their patient-focused drug development guidelines.

Kongsø realised the dire need for an efficient, more structured method for integrating patients’ voice into drug development. With his expertise leading several qualitative projects and managing patient reported outcomes in clinical trials for large companies over decades, he founded Clinigma®. Kongsø’s company is ISO 9001- certified in collecting patient experience data before, during, and after clinical trials, enabling clinical trial professionals to improve the quality of their drug development processes and providing important answers to regulatory bodies and HTAs. The company adeptly helps clinical trial projects conform to the constantly evolving regulations that govern a drug’s validity in the current, competitive marketplace.

Harnessing expertise within the IT space and his own background, Kongsø’s patented software and global network brings together clinical professionals at the trial site to gauge eligibility with interviewers in over 70 languages to gather patient insight at entry, during the trial, and after the fact as well. With vision across the trial operations, the technology prevents site burden, secures confidential information, and exceeds safety monitoring requirements all while clients can follow the progress.

We help provide a more complete picture of how a specific treatment impacts a patient’s life, and focus on linking quality of life responses to what patients say in their own words

According to Kongsø, failing to synchronise these various efforts can jeopardise the legitimacy of the results for the whole trial.

Clinigma offers the complete solution that resolves such challenges and brings a sense of clarity and value to clients, allowing them to carry out seamless drug development processes with actionable patient experience data and insights. Intensive projects have tailored efforts in interviews and data analysis right from the start when scoping a protocol, while others will need immediate responses to meet regulatory feedback. With a calm nature from decades in drug development, Kongsø’s team has developed a standardised interview manual through rigorous efforts that is ready to meet clients’ needs at a moment’s notice while living up to the regulatory guidelines. In either case, Clinigma®’s ISO 9001:2015 certification can assure clients systematic, results-driven analysis that links patient voice to traditional outcomes, increasing their explanatory value. “We help provide a more complete picture of how a specific treatment impacts a patient’s life, and focus on linking quality of life responses to what patients say in their own words,” adds Kongsø.

By continually striving to achieve this mission, Clinigma has been successful in optimizing clinical trial results. He enjoys guiding clients on what to focus on in clinical trials, revelling in this new nexus of IT and patient voice to resolve issues he had seen for years. Seemingly in all time zones, his hands-on approach means Clinigma team members can always consult him for insight and to consider new ideas. With his energy, the company now offers more than 15 independent, tech-facilitated solutions in patient experience data that combine to meet client needs with novel strategies based on the latest international regulatory guidances and advancements in IT and mixed methods approaches. As these solutions make their way into peer-reviewed publications, the nimble company continues to identify new clinical endpoints in a typical drug development journey, furthering knowledge of unmet needs, disease and treatment burden, and real-world evidence through patient-experience data.

Clinigma® is a leader in the clinical trial management space with its easy patient scheduling solutions in and outside of clinical trials and rigorous, efficient research strategies offering incredible value on an international scale. The company’s secure, seamless patient experience data collection processes provide regulatory bodies and pharmaceutical corporations confidence in trial information. With the help of Clinigma, the many barriers for accommodating the expectations of regulatory bodies for a patient centered drug development have never been easier to overcome.