Clinmark
Revolutionary approach in Clinical Project Management

An inadequate patient enrolment and recruitment framework can adversely affect the quality of a clinical trial outcome and leave the pharmaceutical companies with an inaccurate trial result. The key reasons for these pitfalls are complex and confusing trial protocols, ill-prepared recruitment strategy, and insufficient enrolment efforts. To solve these challenges perturbing the realm of drug trial and monitoring stands Clinmark. A leading contract research organisation (CRO), Clinmark is committed to simplifying this cumbersome process of patient recruitment for pharmaceutical and biotechnological companies through their clinical trial operations and consulting services.

In an interview with Pharma Tech Outlook, Dr. Marek Wasiluk, CEO and Dr. Grzegorz Pogorzelski, Chief Strategy Officer (CSO) of Clinmark, offer insight into how their company brings a world of difference to the clinical trial and monitoring space with the help of their services.

Clinmark is working at the core of the drug trial industry, specialising in clinical trials. What has the journey been like?

Wasiluk: Established in 2001, Clinmark has organised, conducted, and supervised several clinical trials (phase I to IV and non-international studies) across the Central and Eastern Europe (CEE) countries. Apart from drug trials, we have also undertaken consulting services such as overseeing research processes, assisting in vendor selection, measuring the project quality, and conducting a risk assessment. Our robust consulting services have helped several pharma companies develop superior operational research quality and efficient recruitment in the fastest way. Along with our set of seasoned medical experts leveraging their deep medical insights, we have successfully performed over 350 audits projects, helped recruit 19,600 patients, and conducted over 230 trials.

Pogorzelski: Owing to our vast industrial experience, we also offer hands-on training and development programmes to existing medical professionals and fresh industry entrants (start-ups) aspiring to leave a mark in the realm of clinical trial and drug development. These training modules are customisable and tailored to the need of these clients.

How does Clinmark tackle the challenge of recruitment and enrolment faced by pharmaceutical companies across the globe?

Wasiluk: Presently, the global CROs are expanding their organisational structures, merging with other CROs, and deploying technology to build e-systems, which in turn is simplifying their data management and many other routine medical practises. However, these efforts are not yielding desired results for their clients in the best and most effective way due to the lack of the right methodology and operational engagement.

We are often asked, “If there exists a way to solve this—a holy grail?” And, Clinmark is the answer. While working with several biotechnology and pharma companies, we have successfully compiled the best practices of various CROs and created a revolutionary project management model-based on a small organisation with a global network.

Could you please elaborate on the services rendered by Clinmark, and how do you help your clients outside Poland?

Pogorzelski: At Clinmark, we operate with the vision of maintaining consistency and effectiveness in our work by abiding to the highest standards of service and striving to stay one step ahead of our customer’s needs. We leverage our proprietary smart enrolment model starting with an in-depth analysis of the clinical trial settings, followed by trial design, ending with the study allocation in the best places for goal achieving.

We, as a company, value collaboration as a paramount driving factor against all the burgeoning challenges in the healthcare domain

To ensure that the trial adheres to all the medical standards of care (SOC), Clinmark examines the trial procedure and indicates best countries or suggest amendments. Once the trial makes its way through all the SOCs, Clinmark’s experts carry-out ‘feasibility result assessment.’

Through this, several crucial factors like the enrolment potential, accessibility, and geographical barriers are tested. In the final stage, the medical specialists present complex expertise and action plan that addresses every need of a client and facilitates a successful enrolment process. However, if the sponsor belongs to a country where we do not have own specialists, we use a model called “Smart Global methodology,” which allows us to launch trial in almost any country within a few weeks. This helps us to proactively explore newer markets and hand out our consulting services to locally-rooted medical organisations.

Wasiluk: To achieve accurate outcomes at the end of a trial, our team of experts also conduct due diligence to ensure business, operational, and research quality standards. With the prowess of these services, today, we have carved a niche for ourselves in drug development, testing, and consulting landscape for chronic diseases like oncology, rheumatology, and many more.

What do you consider to be the most important elements in project management?

Wasiluk: In my experience, clear rules of conduct contained in our methodology are the essential elements of a project. In addition to that, our team of experts is equally adept in education, experience, and training—to perform GCP (Good Clinical Practice) audits. These facets increase the quality awareness of a trial and form a broad perspective on project delivery. Such experience is also of great importance in rescue studies, where Clinmark is practically the first choice CRO for most pharmaceutical companies.

To get a deeper understanding of your company’s contribution to the client, can you share an interesting case study where Clinmark has helped its clients overcome complex recruitment challenges?

Pogorzelski: While working with a prominent pharmaceutical company, we were asked to support their patient recruitment process as a rescue action of a study of a rare disease. The rescue project’s initial analysis was targeted in 12 countries, out of which 5 of them were found to be suitable for the next stage of the deep selection process. Finally, Clinmark prepared an effective action plan for the client and helped them in successfully set up the whole rescue study only in 6 sites of 2 countries. Apart from prompt patient recruitment, we were also able to impact the motivation of others.

Looking ahead, where do you see your company in the next few years?

Wasiluk: As a prominent leader in the clinical trial management space, Clinmark has deciphered the importance of healthy partnerships and believes in joining hands with the other CROs in the market rather than competing with them. We, as a company, value collaboration as a paramount driving factor against all the burgeoning challenges in the healthcare domain. Against all the stereotypes that a small or mid-size CRO does not have a good chance of expansion or growth, we are proving that clients want to work and collaborate with us, because we are giving them concrete benefits. Continuing with this zealous attitude, we are aiming to reach the highest rung of the clinical trial ladder and contribute meticulously to the ever-evolving patient recruitment space.