BiTrial Clinical Research

Last Call: We’ll be at the OCT New England 2024 Conference in Boston! 🌍 Our Director of Clinical Operations, Péter Hársfalvi, PharmD, will be there to meet with you and discuss how BiTrial can support your clinical trial needs.🤝 Save the date: 📅 Date: 23 - 24 October 2024 📍 Location: Boston, Massachusetts, USA Want to schedule a meeting with Péter? Feel free to send him a direct message. He’s always happy to discuss how we can collaborate to enhance your clinical trials! For more details, check out our page 🔗 www.bitrial.hu Looking forward to seeing you there! #conference #croconference #pharmaindustry #medicaldevices #hungariancro #croeurope #fullservicecro #medicaldevelopment

It was a fantastic experience filled with insightful presentations. We were excited to contribute to the discussions on the latest trends and innovations in clinical research. We're already looking forward to the next conference!

Our next stop in introducing key locations for clinical research: Moldova 🌍 In our series showcasing BiTrial’s international presence, we highlight the dynamic research landscape and the key role Moldova plays in our global strategy. ✅EU candidate country: Moldova is on the path to joining the European Union, which accelerates the alignment of its regulatory framework with EU standards, offering a promising future for clinical research. ✅ Fast-track review timeline: As of March 2024, Moldova's Health Authority (HA) has implemented one of the fastest review processes worldwide for clinical trials, with a 10-day fast-track for all phases (I-III) and a regular review set at 21 working days. This efficiency makes Moldova a prime location for initiating trials rapidly. ✅ Patient motivation: Moldovan patients are highly motivated to participate in clinical trials and demonstrate strong loyalty, resulting in low dropout rates and faster, more effective recruitment. ✅ Skilled medical professionals: Moldova boasts a well-educated healthcare workforce, with many professionals fluent in multiple languages, including Romanian, Russian, and English, facilitating smooth communication and high-quality clinical trial management. ✅ Centralized healthcare system: The country’s centralized healthcare system, with specialized medical centers, allows for easier trial management and communication. Visit our website to find more information about our CRO services and international presence. 🌐 www.bitrial.hu #clinicaltrials #cro #biotech #pharma #healthcare #clinicalresearch #moldova #bitrial #globalhealth #medicalresearch

The BiTrial team was thrilled to participate in the IX. Clinical Trials Conference and GCP Course! 🌍🤝 This year’s event featured numerous inspiring presentations, and we were delighted to take part in a discussion on the latest trends and advances in clinical research. 🔬 We believe in continuous development, and conferences like this one play a key role in ensuring our team is up-to-date with the most current knowledge. As a dynamic, youthful, and motivated team, we always strive to evolve and grow.💯 We would like to extend our thanks to Kalman Torocsik MD and his dedicated team for their efforts in organizing such a successful conference!  If you’re interested in how we can support your clinical trial needs or wish to collaborate, feel free to connect with us! 📲 🔗 www.bitrial.hu #clinicaltrials #gcp #bitrial #teamwork #professionaldevelopment #conference #mkvt

Exciting opportunity: Let’s meet at the OCT New England 2024 Conference! 🤝 The 16th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial experts from large and small biopharma companies to explore innovative technologies and streamline their clinical and outsourcing operations. 🌏 Our Director of Clinical Operations, Péter Hársfalvi, PharmD will be there to represent the BiTrial team. Whether you’re interested in discussing potential partnerships or learning more about how we can support your clinical trial needs, we’d love to hear from you! 🔗 If you'd like to schedule a personal meeting with Péter, send a direct message. We’re looking forward to connecting with  potential partners and colleagues from across the industry.🤝 📅 23 - 24 October 2024 📍 Boston, Massachusetts, USA For more details visit the conference website 👇 https://lnkd.in/g6BcA8qh #clinicalresearch #cro #bitrial #octnewengland #networking #healthcareinnovation

Learn more about the life path of medical devices! Let’s explore the 5th stage ➡️ The conduct of clinical trials. 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 ensure that medical devices meet the strictest regulatory requirements and are safe and effective for patient use. What are the key tasks involved in clinical trials? ✍️ Compiling the Clinical Investigation Plan (CIP) based on MDR and ISO 14155 ✍️ Developing the Investigator’s Brochure (IB) as per MDR and ISO 14155 ✍️ Compiling essential documentation for the study ✍️ Conducting feasibility studies in participating countries ✍️ Obtaining regulatory approvals from the Competent Authority and Ethics Committee ✍️ Conducting the clinical trials ✍️ Collecting & evaluating data With ample expertise, BiTrial offers comprehensive end-to-end service support, ensuring seamless integration and execution across all stages of the clinical trial conduction.✔️ Learn more about our services and how we support research development on our website! 🌐 www.bitrial.hu #bitrial #croeurope #hungariancro #medicaldevicedevelopment #clinicaltrials #cro #healthcareinnovation #clinicalresearch #medicaldevices #healthcaresolutions

We are proud to present Montenegro, the standout country in our international portfolio.🌍 The country is a hidden gem, often referred to as "Crna Gora" or "black mountain"  by its inhabitants. As an EU candidate country and an independent republic in the Balkans, Montenegro is making significant progress in the development of health infrastructure. 📈 Discover the highlights of Montenegro: 🔍Efficient regulatory process: The country’s regulatory landscape enables fast and transparent official approval processes. 👥Diverse population: Despite its small population, Montenegro simplifies participant recruitment, ensuring faster data collection. 👨⚕️ Skilled professionals: The country boasts skilled healthcare professionals who are meticulously conducting and managing high-quality clinical trials. 💰 Cost-effective operations: Lower operational costs, including personnel, facilities, and administrative expenses, make Montenegro an attractive location for clinical research. BiTrial is proud to build on these strengths to deliver world-class clinical research services. Follow us to learn about our international presence or visit our website to learn more about our international services and how we can support your clinical research needs.🤝 🌐 www.bitrial.hu #bitrial #clinicaltrials #crohungary #croeurope #cro #healthcareresearch #montenegro #globalpresence #clinicalresearch

📢 FDA releases new draft guidance on Diversity Action Plans in clinical studies In June 2024 the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Diversity Action Plans to improve enrollment of participants from underrepresented populations in clinical studies.” This new guidance outlines FDA’s expectations for Diversity Action Plans (DAPs) required in certain clinical studies, detailing the format, content, and submission process. What is a Diversity Action Plan? A DAP details the enrollment goals and strategies to ensure diverse representation in clinical studies. The aim is to improve the inclusion of historically underrepresented populations, aligning with FDA’s long-term policy goals. ⚕️ ✅ Comment period for the draft guidance closes on September 26, 2024. ✅ DAP requirements expected to take effect for trials beginning enrollment in late 2025. 🌐 For more details, download the full draft here 👇 https://lnkd.in/gNczUwNA Follow our page to receive updates in clinical research! 🚀 www.bitrial.hu #bitrial #cro #hungariancro #croeurope #clinicaltrials #fda #diversityinclinicaltrials #healthcare #biopharma #clinicalresearch #regulatoryaffairs #medtech #clinicaldevelopment #healthcareinnovation

🔎 Learn more about the lifecycle of medical devices! In our series on medical device development, we’re moving on to the 4th stage: Establishing a clinical evaluation plan. This phase is vital for ensuring that all clinical aspects of the device are thoroughly evaluated and documented. 📋 Here are the key elements of this phase:👇 📊 Identifying relevant and specified clinical outcome parameters: This involves determining the clinical outcomes that need to be measured to assess the device's performance and safety effectively. 📑 Clinical development plan: This is a comprehensive plan from the initial human trials to post-marketing clinical follow-up, which includes the following documentation👇 ✅ Pilot studies: Small-scale studies to test the device's feasibility and safety ✅ Confirmatory studies: Larger, more definitive studies to confirm the device's efficacy and safety ✅ Post-Marketing Clinical Follow-Up (PMCF): Ongoing studies after the device has been marketed to monitor its long-term performance and safety Stay tuned as we continue to unpack each step of the medical device development process! 🚀 Did You Know that BiTrial's extensive services also include the preparation of clinical evaluation plans❓ Visit our website to learn more about our comprehensive CRO services! 🤝 🌐 www.bitrial.hu #bitrial #cro #hungariancro #croeurope #medicaldevices #clinicalresearch #clinicaltrials #healthcareinnovation #medicaldevicedevelopment

Discover BiTrial's global presence from our series showcasing the countries where we operate. The next country we’re introducing is Armenia. 🌍 This country offers numerous advantages we can successfully leverage in the field of clinical research. ✅👇 📅 Eurasian Economic Union (EEU) Member Since 2015: Armenia's membership in the EEU has been instrumental in bolstering its healthcare infrastructure, with continuous government investments driving improvements. 📝 Regulatory efficiency: Achieving complete regulatory approval in about 40 days, Armenia demonstrates impressive efficiency despite not being an EU member country. 👥 High enrollment rates: Armenia has a diverse patient population with a strong willingness to participate in clinical studies, contributing to high enrollment rates. 👨⚕️ Skilled medical professionals: The country boasts a growing number of well-trained, skilled medical professionals and researchers, ensuring high-quality clinical trials. 💰 Cost-effective trials: Conducting clinical trials in Armenia can be significantly more cost-effective compared to many Western countries, making it an attractive location for research. 🌐  Visit our website to learn more about our global operations and comprehensive CRO services!  www.bitrial.hu #bitrial #clinicalresearch #armenia #globalpresence #patientrecruitment #cro #fullservicecro #medicalsupport