Services
KCR S.A. offers a complete range of services in design, initiation and management of clinical trials programs. We have experience in almost all therapeutic areas, in particular in CNS, cardiology, diabetology, oncology, rheumatology, psychiatry and infectious diseases
KCR S.A. is able to effectively conduct even the most demanding projects taking the responsibility for the highest quality of the following services:
SERVICES
• Project design
• Feasibility and study set up
• Investigators’ trainings
• Regulatory affairs
• Project management
• Site management
• Study monitoring
• Medical advisory and pharmacovigilance
• Support to patient recruitment and retention
• CEE health care consulting
Project design
We would be happy to assist our customer in setting up the project from the very beginning. With the help of the key opinion leaders from our Scientific Council, KCR’s experts can advise on study protocol and deliver clinical trial designs that effectively address the sponsor's objectives in a timely and efficient manner
Feasibility and study set up
We do have notable experience in working with sponsors on developing clinical trials that address the needs of both partners. Feasibility studies are carried out by our experienced staff in close cooperation with our international network of reliable investigators. An extensive feasibility research is the first step not only towards careful and efficient country and site selection but also to realistic time and cost estimates.
Site selection
As a result of our feasibility studies we have developed a continuously updated database of our international network of investigators. In our analyses we also refer to the past results and metrics from completed projects. It is important to identify all constraints and limiting factors at the very beginning. Our main goal is to deliver reliable and up-to-date information about study centers identified from our experience as well as suggested by our customer.
Investigators’ trainings
As a long-time specialist in providing trainings to clinical research professionals in Poland, we want to make sure that our investigators have been appropriately educated and prepared for conduct of clinical trials. Therefore we invest in investigators’ trainings to secure professional and qualified performance of clinical research projects. We are currently developing these services in other countries of our region.
Regulatory affairs
Due to specific requirements and changing demands of the market, our dedicated legal and regulatory staff can provide advice on regulatory procedures in each of the Central and Eastern-European countries. We locally assist the approval process and assure appropriate communication with regulatory authorities. We are ready to work with you to meet aggressive timelines without increasing costs.
Project management
The key to a successful trial is effective management. The complexity of today's clinical trial requirements calls for skilled day-to-day management of multiple activities. Our industry-experienced project managers know how to navigate all the hazards and guide a trial to completion. We delegate only people who are able to build a competent coordination and communication plan for the project.
Site management
In our experience of study sites monitoring we have always tried to proactively coordinate the work of the research teams. Long-term team work has helped us to build strong and positive relationships with our investigators. Some of these centers have developed structures similar to SMOs.
Based on this experience we set up cooperation with big networks of outpatient clinics and private hospitals in Poland. One of the advantages is an easy access to huge databases of patients.
Study monitoring
KCR assures a highly educated and experienced team of monitors. When assigning staff to relevant projects we always try to take into account their clinical research experience in the particular medical specialty. Our staff is continuously improving their education by participating in internal and external trainings. We are confident that investment in education will result in higher effectiveness and quality of work.
Medical advisory and pharmacovigilance
Safety is the most critical issue in clinical research. Therefore we pay particular attention to pharmacovigilance. As majority of our employees have MD degrees, we are able to provide medical advisory services in various medical specialties. We can assist in writing medical reports regarding adverse reactions and appropriate reporting to agencies.
Support to patient recruitment and retention
Starting from the feasibility period, we develop a strategy of patients’ recruitment in cooperation both with sponsor and investigators.
We have collected significant experience in terms of supporting recruitment as we monitor and advise on this processes on an ongoing basis. We are able to assess capabilities and limitations of each site and tailor choice of site according to the requirements of our clients.
We are aware of the importance of the patients’ retention in the studies, especially the long-term ones. We are prepared to deliver appropriate individualized training and educational programs for investigational teams. We know how to enhance enthusiasm and how to support relationships between investigators and patients.
CEE health care consulting
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