Next level in Project Management

Interview with Clinmark’s CEO Marek Wasiluk

Question: Nowadays R&D area and specifically clinical trials are affected by many challenges. How CROs are dealing with it?

Marek Wasiluk: The market trend is that global CROs are enlarging their structures, merging with other CROs, building e-systems etc. However, such activities do not necessarily lead them to achieve their project goals in the fastest and cheapest way.

Question: Is there any other way – a Holy Grail?

Marek Wasiluk: Yes, there is. For over a dozen years, Clinmark have performed almost 400 audits and consulting projects globally. We have gathered knowledge about various CROs models and its performance and created a revolutionary Project Management - based small organization with global network. Working at the study planning stage, such net allows us to find countries and centers that will effectively provide clinical data. The key aspect is the rejection of 80% of the countries initially taken for analysis. The choice of countries is not dictated by having CRO structures there - such practice is quite common among big CROs although not willingly disclosed. In contrast the independence of the selection and its measurable success results from the fact, that Clinmark has very flexible resources, huge practical knowledge about local markets.

Question: Sounds good, however costs are probably, same as for standard global CROs.

Marek Wasiluk: Our activities are based on market pragmatism, on the motivation of our partners to develop with us. Their involvement is limited to a specific project being performed. Non-project costs do not burden us.

Question: How is this different from sub-contracting, freelancer?

Marek Wasiluk: The difference is significant. In our model each partner runs projects on Clinmark SOPs, is included in the system of training, quality supervision, periodic assessments, and a direct management system. Engaged team members work directly with Clinmark managers. We routinely conduct qualifications and re-qualifications of our partners.

Question: What if the Sponsor needs to perform a trial in a country, where you do not have a partner - a non-standard country?

Marek Wasiluk: Clinmark Smart Global methodology allows launching almost any country within a few weeks. Let me give you examples of such countries as Belarus, Malaysia, Jordan, Cameroon, Saudi Arabia. We are often ahead of customers' needs and proactively explore new markets. We provide consulting services for locally rooted organizations and institutions. Some of them became our partners.

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

Marek Wasiluk: The highest meaning in my experience are clear rules of conduct contained in our methodology, used by well-formed specialists. Our PMs are selected as the best of the team, because we base our operations on them. In addition to education, experience and training, they are also involved in conducting GCP audits in research centers and qualification audits. This increase their quality awareness and forms a broad perspective on the project delivery. Such experience is also of great importance in rescue-studies, where Clinmark is practically the first choice CRO.

Question: The most often reason for rescue action is poor recruitment. How do you solve this?

Marek Wasiluk: Smart Global is also a network of highly specialized hospitals and outpatient clinics located over the world, ready for fast and effective action. Site Network has been organized and developed in the same methodology - to choose sites based on evidence, without bias. Well established cooperation allows to perform quick feasibility, while contracts are already signed. Having easy access to targeted population and strong operational specialists – Clinmark is able always to select 2-3 countries with few study sites which deliver in a short timeframe.

Question: How does it work in practice?

Marek Wasiluk: Clinmark appoints a team of specialists who after targeted analysis presents a complex expertise and action plan. Subsequently we launch an operational team to solve problematic issues and recover effective delivery. I can describe shortly one of our successes how we achieved breakdown in recruitment in rare disease study: 12 countries analyzed, selected 5 of them for start-up. Finally, we opened 6 sites in 2 countries delivering patients and keeping sponsor satisfied due to optimal costs and motivation impact on others.

Question: It is impressive. Congratulation.

Marek Wasiluk: Thank you. Let me add that the above-mentioned activities we use on daily basis in standard trials. It resulted in worldwide FPFV achievements in 3 ongoing trials where global CROs were also engaged.

Question: How do you want to compete with Global CROs?

Marek Wasiluk: Actually, we don’t treat them as competitors. In many projects we operate together complementary filling in orphan areas. Against stereotypes that a small or mid-size CROs do not have chances, we are proving that clients want to cooperate with us, because we are giving them concrete benefits, they know about our advantages against big organizations. In my opinion Clinmark enriches the market of services in clinical trials through alternative solution (1st choice in rescue) and complement to Global CROs (1st choice next to global) maintaining consistency, effectiveness and a high standard of services.

Testimonials

Flexible and cooperative, willing to provide service according to client's expectations

Regional Head of Operations
American Pharmaceutical Company

Flexible and cooperative, willing to provide service according to client's expectations

Regional Head of Operations
American Pharmaceutical Company

Flexible and cooperative, willing to provide service according to client's expectations

Regional Head of Operations
American Pharmaceutical Company

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