Research Professionals Resources
As a leading CRO, Research Professionals shares its knowledge and perspectives regarding Contract Research Organization (CRO) services to be benefit of those interested in the market. Our leadership, technical staff and managers all contribute to this sharing of knowledge through our case studies, articles, and whitepapers. Check back here often for the latest updated information on trends and topics that are relevant to clinical researchers, sponsors and CROs.
Case studies
Adapting to the Clinical Trials Information System (CTIS) Implementation in the EU
The EU introduced the Clinical Trials Information System (CTIS) searchable public database in 2022 to support the flow of electronic information between clinical trial sponsors, European Union (EU) Member states, European Economic Area (EEA) countries and the European Commission.
Accelerating Submissions Under New EU Medical Device Regulations (MDR)
With the implementation of the updated EU MDR regulations in 2021 and 2022, medical devices that have a CE (Conformité Européenne) mark that predates the new regulations must be reviewed for conformity with the new standards. In addition, new medical devices coming onto the market will have to meet the new requirements, in many cases supported by clinical data, where it wasn’t previously required.
Languages Available
Reducing Overall Timelines Through Efficient Recruiting
RP-CRO was engaged by a Western-European sponsor company to manage separate First in Human (FIH) and subsequently Safety/Efficacy multi-center studies for a medical device product. The device was surgically implanted and was used to treat renal patients requiring hemodialysis. Therefore, the suitable subject pool for these studies was limited, making the recruitment of subjects one of the biggest challenges for RP-CRO.
Expanding Recruitment Strategies and Cost Reduction
Research Professionals CRO had been contracted to support a local region as part of large global cardiomyopathy placebo-controlled study. The global study had planned to recruit 510 subjects across 117 study locations in order meet the total number of required subjects for the study design.
Computer Guided Dental Implant Study: Supporting start-up sponsor company through early phase randomized clinical trial
Research Professionals (RP) is a leading GCP compliant CRO based in the EU member Hungary with operations in Poland, Czechia, Romania, and Bulgaria, serving customers from across Europe and the globe.
DicomLAB Dental Ltd is a med-tech company dedicated to creating a computer-guided dental implant platform that improves precision, safety, and patient outcomes. The SMART Guide platform is used to aid with implant precision.
Articles
Advantages of conducting clinical studies with CROs in Central and Eastern Europe
November 8, 2021 - Interview with Research Professionals’ (CRO) György BARTA who serves as Managing Partner for Research Professionals, a leading GCP complaint CRO. The interview provides insights into potential advantages to conduct clinical studies in the Central and Eastern Europe (CEE) region with Clinical Research Organizations (CROs) like Research Professionals.
How to Reduce your Clinical Study Budget with a CRO in Central and Eastern Europe
February, 2022 - Clinical research studies for pharmaceuticals and medical devices are complex and expensive programs. Every study can be so critical that running a good one can make the difference between your product failing or making it to market. Working with large high-quality Clinical Research Organizations (CROs) in established western markets can be very expensive to achieve high-quality study programs.