KCR
Powering Clinical Research Excellence

Clinical research marks a pivotal point in the drug development process as it assesses the safety and effectiveness of medications, devices, and treatment regimens planned for humans. However, conducting a clinical research in the changing healthcare economy is not a simple task; it is resource intensive and a high-risk process, which requires a fine balance between clinical infrastructures, stringent regulations, and advanced technologies to execute it to perfection. Clinical research processes also require highly skilled people who have in-depth expertise in performing clinical trials, duties, and functions. Despite having highly proficient executives, pharmaceutical and biotechnology companies still face difficulty in carrying out the clinical research process. As basic research and development, and prioritization of sales and marketing take precedence, pharma and biotechnology companies are not able to focus on clinical research. The increasing complexity of clinical studies, need for experts in therapeutic areas, and increased focus on safety to meet regulatory hurdles, have pressurized pharmaceutical and biotechnology firms to outsource research activities to a contract research organization (CRO) for better management of peaks and valleys in development activities. The need of the hour is a reliable CRO partner that can add significant value to their complex clinical medical research.

Considering the nature of the current market demands, a key enabler helping pharmaceutical and biotechnology companies excel in their drug development journey is KCR, a prominent contract research organization. For over a decade, KCR has proven to be a trusted partner in offering groundbreaking clinical development solutions for the pharmaceutical, biotechnology, and medical device industries. “Our task as a CRO is to make the drug development process easier and faster, provide investigative sites for investigators, and find right participants for the study,” begins Mike Jagielski, president and CEO of KCR.

New Paradigm in Clinical Trial Execution

As a part of clinical development solutions, the company offers full-service capabilities across three main services namely trial execution (TE), functional service provision (FS), and trial execution consulting (TC).

When it comes to execution of clinical trials, CROs face myriad challenges.

Compliance monitoring can be a significant contributor to the success of mHealth trials

Patients can be hard to find, site investigators may become frustrated by slow payment for their services and competing needs of the sponsor, investigators and patients may make logistics more difficult to manage. KCR with more than 300 professionals having a sea of experience in clinical trials along with robust infrastructure is well equipped to conduct clinical trials, from a single site local study to multi-center programs spanning different regions. The comprehensive trial execution services offered to pharmaceutical and biotechnology firms include project management, clinical monitoring, site management, and more.

Projects and processes are a vital part of every business. To achieve success at a research site, organizations should have a plan for each protocol to ensure that tasks are carried out accurately and in a timely manner. In order to work efficiently and meet company goals effectively, an organization requires more than just capable employees doing their best. KCR’s proficient project managers act as the bridge between teams and stakeholders on a project, helping them drive business performance and operational efficiency to achieve sustainable clinical trial success. KCR’s professional teams are fully trained and well-positioned to undertake a variety of projects across multiple countries. The KCR team monitors every clinical trial to ensure that clinical study integrity, protocol adherence, patient safety, and accurate data collection is well managed. By leveraging electronic case report form (eCRF) design and data validation development tools, KCR helps accelerate data processing and provides more rapid insights for drug development scientists and operating managers.

Along with clinical trials, the company has also developed tailor-made functional service solutions providing critical resources to fully satisfy the client’s requirements. With vast industry experience, KCR has learned that every sponsor demands accelerated timelines, measurable results, and reliable data. When seeking outsourcing support they also want a customized program and the ability of the provider to react quickly to any contingencies that may arise. KCR responds to these requirements by delivering a high degree of flexibility offering both strategic and tactical solutions across three main areas: clinical operations, data management, and strategic senior expert solutions sourcing. The critical differentiator between these three models is the level of line management integration.

Considering flexibility as the key factor, KCR supports three primary functional service models that include cross-functional sourcing model, functional sourcing model, and insourcing model.

Cross-functional sourcing model ensures comprehensive clinical operations that support multiple protocols. With functional sourcing model, managers delegate dedicated teams specialized in the area of multiple-projects execution. In the insourcing FSP Model, the outsourced line manager is solely responsible for insight control performance management. In other models, the manager assumes the additional responsibility of managing the service function, resulting in greater integration within the sponsor’s organization. With the help of the FSP process, pharma companies are able to reduce timelines and costs of the clinical development process. They can now ensure scalable resources and discover synergies that generate increased efficiencies across all critical aspects of a clinical project.

Recently the company has extended its service portfolio to trial execution consulting (TEC) that supports clients in translating scientific objectives into operational activity. The new service is primarily dedicated to biotechnology companies as well as small and medium pharma companies. With more than twenty years in clinical research, having hands-on experience with EMA and FDA filings, and thousands of clinical research issues resolved, KCR ensures that their clients’ development programs bring better results. The company’s new TEC service is structured and focused on enabling enhanced operational delivery for clients. The clinical research industry has become very complex nowadays, with great time and cost pressure. Having executed multiple projects of high complexity and following years of active collaboration with national and local authorities, KCR is well equipped to share their wealth of knowledge and expertise. TEC covers all areas required for successful execution of the trial including medical expertise, regulatory affairs, and operational guidance. The service focuses on transparency in delivering a variety of solutions while quantifying risks and benefits clearly.

Riding the Wave of Future

Established in the late-nineties by Marek Kiecana, now chairman of KCR’s Supervisory Board, saw a lack of access to new and innovative medications for patients and clinical investigators within the emerging Central Eastern European region. He was aware that pharmaceutical companies were having difficulties finding sufficient numbers of patients for their trials. KCR bridged this gap by extending their footprint in the Central Eastern European region. Today, KCR has grown into an enterprising European contract research organization with a dynamic team of almost 300 professionals, operating across 18 countries and providing services to 12 of the top 20 global pharma companies on long-standing global or local contracts. KCR continues its growth strategy by expanding its capacities to provide clients with customized, reliable and high-quality clinical research services. The future of clinical research depends on the right CRO partner that companies choose in their drug development journey and KCR, as a CRO is undoubtedly flying high in leading this revolution.