This step is the crucial phase of medical device development, where the hard work culminates in the preparation for market launch and commercialisation! 🚀 📂
The Central and Eastern European (CEE) region should stand out as a highly attractive location for clinical research compared to many surrounding regions. But what
Since 2022, we have been collaborating with the CMF (Center for Molecular Fingerprinting), a research institution dedicated to developing next-generation molecular diagnostics. 🔬 CMF’s vision
ISO 20916:2019 is the first international standard dedicated to the design, conduct, documentation, and reporting of clinical performance studies for in vitro diagnostic (IVD) medical
Why is Czechia a key player in our CEE network❓ 📋 EU High Enroller – joined the EU in 2004⏱️ Regulatory pathway aligned with EU/EMA
Once all essential preclinical and clinical data have been gathered, the next critical phase is compiling the Clinical Evaluation Report (CER). This is the culmination
A recently published study introduces the PIPEDREAM model, using aggregated historical data from the pharmaceutical industry between 1997 and 2007. It highlights just how challenging
At BiTrial, we recognize the importance of maintaining the highest standards in clinical research and product development, that includes a deep understanding of FDA inspections.
In our series on the life path of medical devices, today we’re discussing the critical phase of conducting clinical trials. This step is essential to
Here are some key factors that make Serbia an essential part of our clinical research network: 📍 Strategic location: While Serbia is not an EU
