HeaDS: Augmenting Accuracy in Clinical Trials
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HeaDS: Augmenting Accuracy in Clinical Trials

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Leonidas Kostagiolas, Founder and CEO, HeaDSLeonidas Kostagiolas, Founder and CEO
It was the year 2010 when, while working as a project director in a pharmaceutical company, Leonidas Kostagiolas observed a significant rise in operational monotony among the contract research organizations (CROs). The lion’s share of CROs in the market was heavily targeted on delivering the maximum number of clinical trials, rather than focussing on the quality of the trial outcomes. This was leading to futile investments, wasted resources, and in some extreme cases, complete failure of trials. He very quickly discerned that the discovery of therapeutic molecules for multiple chronic diseases like cancer and blood disorders required more concentrated attention and distinct clinical trial methods.

Driven by this conviction and urge to bring better trial practices in the realm of drug testing and monitoring, Kostagiolas established HeaDS, a full-service European contract research organization (CRO) engaged in conducting clinical studies (Phase I-IV), data monitoring, and consulting, with particular expertise in hemato-oncology. “We really wanted to put our skin in the game and conduct quality medical trials,” says Leonidas Kostagiolas, founder and CEO of HeaDS. Since its inception, HeaDS has been posed to do just that, constantly engaged in providing end-to-end services including clinical operations, biometric intelligence, and regulatory operations. It is the company’s firm belief that clinical research cannot be compartmentalized and must be viewed holistically as each service, each department, each deliverable has incredible overlap over the others.

These arrays of services form the lifeblood of the company’s research and are executed by a group of experts with deep scientific backgrounds and out of the box thinking. At its core, HeaDS strives to employ passionate professionals to design, develop and deploy software that enables seamless execution of clinical trials through in-house biometric tools.
“Behind every successful clinical trial is a diligent team of researchers who employ critical thinking and superior technical capabilities,” says Kostagiolas. A key point of focus in each trial and in HeaDS’ portfolio overall is the formation of a medical affairs team of the highest calibre, to ensure appropriate medical training of each involved member in clinical research (from CTAs to SAS programmers) and of course to safeguard the scientific integrity of the trial.

However, what truly sets the firm apart from other CROs in the market is the robustness of the biometrics and data management services offered completely in-house. HeaDS is focused on developing cutting-edge technological solutions like their proprietary cloud-based electronic data capture (EDC) platform, capable of managing big and complex patient data and at the same time focusing on user experience. In-house means complete freedom and so our team of developers and data programmers are ready to implement any kind of report or add-on functionality to stream line operations and data review processes in the trial.

To further reiterate the competence of their services, Kostagiolas throws light on a client success story. In a phase three study undertaken by HeaDS, recruitment was paused due to a formulation change in the product, which resulted in considerable downstream changes in the timelines of the trial. The client demanded a new projection with a narrower margin. In order to counter this crisis, the research team at HeaDS conducted detailed site-level interviews to grasp the recruitment potential and created an algorithm not only by using the recent patient data but also considering the historical data. This charted a recruitment curve that was more accurate, thereby completing the trial on time and delivering satisfactory outcomes for the client.

Moving with this pivotal grace, HeaDS plans to undertake many more such challenging and quality projects, and simultaneously deploy innovative technologies. In addition, the company also plans on bringing data visualization and reporting in their workflow to provide complete control to the client at every step of the clinical trial. Highlighting the prowess of technology in bringing forth new innovations in the pharmaceutical tech space, Kostagiolas concludes by saying, “We strongly believe that technology is the driving force for the growth of CROs, and with our proven expertise and capabilities we are determined to reach that zenith.”
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HeaDS

Company
HeaDS

Headquarters
Katechaki St, Greece–South Docklands, Ireland

Management
Leonidas Kostagiolas, Founder and CEO

Description
An European contract research organization (CRO), engaged in conducting clinical studies, data monitoring, and consulting, with particular expertise in hemato-oncology studies. Founded in 2010 by a health economist and a biostatistician, HeaDS has positioned strategically in producing innovative late phase designs and introducing technology in monitoring activities so as to increase data quality and reduce costs. They also bring the convergence of expertise required by industry agents, payers and insurers paired with technological innovation. HeaDS’ therapeutic experience includes the areas of diabetes, cardiovascular diseases, central nervous system, dermatology, hematology, hospital acquired infections, oncology, pain, patient preferences, respiratory diseases, rheumatology urology and treatment value frameworks