KCR is a contract research organization that oversees trials in 25 countries, with experience in oncology, immunology, central nervous system, vaccines and rare disease studies. Outsourcing-Pharma (OSP) recently spoke with KCR CEO Mike Jagielski (MJ) about how the pandemic has caused (and accelerated) changes, and how a global presence can benefit clients.
OSP: Please share your perspective on how the clinical trial industry has evolved—both in the months/years leading up to the start of the COVID-19 pandemic, and since the virus landed.
MJ: Before the COVID-19 pandemic, the clinical research industry was in a constant state of development with a primary focus on new solutions for patient recruitment, digitalization, and data accessibility and transparency. These changes, especially technology-based changes, were often implemented slowly (compared to other innovative industries) over the course of many years for a variety of reasons: manufacturing and supply chain complexities, pricing, risk etc.
The pandemic forced many clinical organizations to implement innovative solutions for enhanced patient support and study continuity during these particularly tumultuous times. If I should focus on one item, I would say the remote site monitoring has been taken to the next level. Sites also saw the real need to catch up, especially ex-US.
OSP: What kind of recent trends you have seen being fully implemented by the industry? What your company choose to follow as a mid-size CRO?
MJ Decentralized trial execution is a topic that we have been hearing more often. We will see that progression from region to region, which will require even more trial customization. The cost/benefit calculation for scale application is still out; I am optimistic that certain things like centralized patient follow-ups from multi-lingual call centers will be implemented at higher rates.
OSP: KCR is global in the real sense of the word. Could you please share the advantages of having people and resources in place in different parts of the world, and how that benefits your clients?
MJ: KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, with main operational hubs located in Boston, Warsaw, Berlin and Kiev respectively. Our strategic hub locations allow for the optimized delivery of clinical development solutions for all clients across the globe.
This serves us well on the ground at clinical sites, where our clinical leads and monitors are native language speakers in all operational regions and on a larger scale, our clients benefit from our leadership teams’ expert understanding of regulatory and legal guidelines in all working regions. This not only ensures confidence in our clients but speeds up study times and adds financial value as well.
OSP: What are your goals for the future? How would you see KCR in a few years’ time taking into consideration recent challenges the industry is facing?
MJ: In 2021 and beyond, KCR aims to continue to be the clinical development partner of choice for global biotech companies while pushing boundaries in the innovation and adaptation of direct patient engagement technology and development strategies. In doing so, it is our mission to remain a private enterprise – growing organically to ensure secure, long-term development.
OSP: What else would you like to add about your company and work?
MJ: KCR’s expertise in the European market and with European regulatory bodies alike makes them a prime partner for companies with global ambitions – but their success in patient enrollment across countries and regions should also ensure confidence in sponsors.