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
Accelerating Early Phase Studies with a Central and Eastern European (CEE) based CRO
July 2024 - Partnering with the right CEE-based Clinical Research Organization (CRO) to manage a new drug product through phase I/II clinical studies is critical to successfully advancing early-stage products.
Finding CROs with the specific knowledge, experience, and capabilities that can help guide sponsor companies through the unique challenges of early phase studies, while staying on time and on budget can be a challenge.
Adapting to the Clinical Trials Information System (CTIS) Implementation in the EU
November 2023 - 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)
June 2023 - 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.
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Integrated Clinical and Decentralized Approach to Accelerate Clinical Trials
February 2023 - An emerging U.S. based life science company, with operations in Europe, came to Research Professionals for assistance because they were seeking to re-start and expand their stalled clinical trial. The sponsor had encountered challenges with the study protocol submission in one country combined with overall recruitment shortfalls. The study was halted as a result. They needed a clinical research service provider that could alleviate these challenges and complete the study under tight timeline requirements.
Reducing Overall Timelines Through Efficient Recruiting
October 2022 - 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
June 2022 - 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
November 2021 - 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
Clinical Study Quality with Central and Eastern European (CEE)-based Contract Clinical Research Organizations (CROs)
November 2024 - Based on recent U.S. Food and Drug Administration (U.S. FDA) data compiled over the last 15 years, clinical studies conducted in Central and Eastern European (CEE) countries have earned some of the highest frequencies of No Action Indicated (NAI) findings by the agency.
This is the best possible inspection result indicating that no objectionable conditions or practices were observed during the inspection.
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.
Advantages of conducting clinical studies with CROs in Central and Eastern Europe
November 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.