Our facilities are located in Ljubljana near centre of town (Business Centre Rudnik). To our participants we offer easy access and high quality accommodation. Our facility has 72 beds with all necessary equipment to perform quality service to pharmaceutical Industry. Our staff and collaborators are professionals with many years of experience. Our two clinical trial facilities include adaptive clinical pharmacology units for Phase I and II studies in healthy normal volunteers (HNV) and patient populations for small and large molecules. For long or short stays, our units have a team of experts to conduct trials in a range of therapeutic areas. With dedicated in-house pharmacy, we are the single-source solution to your small and large moleculeearly-phase clinical trial needs. Partner with us for your early phase clinical studies. We customize our process to suit your requirements—working with you to design the most robust clinical program, and conducting the testing that advances you through the phases with ease. Our advanced level of clinical expertise enables us to successfully recruit and conduct clinical trials involving a broad range of healthy normal, special, and patient populations. Leveraging a combination of our existing database and proactive participant outreach strategies, we can help you get ahead in a wide range of study types, methods of administration, and therapeutic areas.
Dedicated research physicians oversee all aspects of clinical trials to ensure that medical and technical procedures are completed to the highest standard of quality, from subject recruitment to subject discharge. Full-time research pharmacists, highly skilled in extemporaneous and intravenous preparation, including biologics.
At CRS, our Data Managers have developed fully validated electronic data capture systems. We have integrated data assurance into every stage of our clinical trials through to its presentations in regulatory and guidance compliance report.
CRS designs clinical trials and develops clinical protocols in a collaborative process that draws on our clinical and bioanalytical experts. Our study designs are continually evolving to incorporate new data and analysis methods, updates in regulations, and proactively mitigate risk. The collaborative process continues through to the finalization of the clinical study report, ensuring an accurate, comprehensive presentation of findings and analysis. CRS ’s all-inclusive package provides quick, cost-effective, submission-ready study deliverables that comply with regulatory and guidance requirements.
CRS’s Scientific Affairs team is comprised of experts whose knowledge spans the breadth of the pharmaceutical and medical sciences. Our scientists have advanced degrees in pharmacy, pharmacology, life sciences, biostatistics, and more. Our team is well positioned to handle your scientific needs from clinical trial design, protocol development, sample size estimation, data analysis, and reporting. Our subject matter experts are involved in every aspect of trial design, working with you to help achieve a successful outcome for your study.
CRS has a wide range of clinical trial expertise, evaluating safety, efficacy and quality of medical treatments across all therapeutic areas. Our expertise lies in designing and executing well-controlled trials, collecting and analysing data and contributing to the advancement of new drugs and medical interventions.
CRS’s extensive database of healthy male and female volunteers enables us to conduct clinicaltrials with gender or age restrictions that are broad or strict. We can accommodate trials specifically for males or females, for an adolescent or other population. CRS Clinic has a long-standing presence in the community and has developed an extensive database of diverse study participants in order to adhere to the requirements of any protocol. Our database offers a true representation of the general population. We conduct clinical trials that include people of varying age and gender that meet regulatory diversity expectations.
19+years of innovator and generic drug development. Successful history of working with regulatory agencies internationally. At CRS what we do best is understanding clients’ needs and what protocol requires, executing studies in a very quality driven and client focused manner. Provide strategically located clinical pharmacology trials units, with 72 clinical beds deviden into two units. We have numerous employees from medical, nursing and laboratory staff including site coordinators. Our purpose built clinic and processes are designed for our experienced clinical team to conduct simple and complex clinical trials including pharmacodynamics and safety assessments across wide range of therapeutic areas.
Our database is continuously expanding to include patient populations, including but not limited to post-menopausal females, smokers and recreational drug users, patients with respiratory diseases, patients with gastrointestinal or endocrine diseases and patients with allergies. CRS ensures on time delivery of full participant panels and quick study start up. Our in-house call centre operates 6 days a week. Our database includes extensive screening histories. CRS partners with hospitals and can manage independent clinical sites ans additional patients sites .We have relationships with local hospitals and clinics to ensure that we can conduct clinical trials with patients, or in specific population or age groups, as necessary for your projects. We can accommodate long or short stays in our upscale, well-appointed, CRS clinical pharmacology units. Our team understand how important study participants are, we ensure gaming rooms, ensuring upscale facilities, access to high speed wi-fi, best selection of meals and high retention rates. We are creating an environment where participants are happy and respected, always collecting feedback. At CRS , safety is always a top priority and we insist on highest safety measures. Principal investigators are physicians, who are highly involved in every aspect of a study .
At CRS, you will be treated like a colleague, your project becomes our project. We create harmonised relationships.
At CRS, our Data Managers have developed fully validated electronic data capture systems. We have integrated data assurance into every stage of our clinical trials through to its presentations in regulatory and guidance compliance report.