KCRI Holiday Gathering ✨ This week, the entire KCRI team gathered to celebrate the holiday season at our annual Christmas event. It was a wonderful opportunity to reflect on the year’s successes, strengthen our bonds, and share the festive spirit. Here's to celebrating our achievements and the people who make them possible! #HolidayGathering #TeamSpirit #CelebratingFestiveSeason #Teamwork
Informacje
KCRI is a provider of clinical research services for medical device manufacturers. We cover broad therapeutic areas, including but not limited to cardiovascular, orthopedics, general surgery, ophthalmology, pulmonary disease, and ob-gyn. We are also happy and excited to investigate new devices: mHealth / eHealth / algorithms/sensors/apps. With extensive therapeutic, scientific, and imaging expertise, we help health sciences customers achieve ambitious goals in a demanding regulatory environment. Proven regulatory knowledge in Europe, a team of dedicated PM and CRAs, professional data management and statistical services, Core Laboratories, and operations of Data Monitoring Committees - this is KCRI. Are you seeking an experienced CRO with a research perspective and medical device experience? Contact us at learnmore@kcri.org - we will help.
- Witryna
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http://kcri.org/
Link zewnętrzny organizacji KCRI
- Branża
- Usługi badawcze
- Wielkość firmy
- 51-200 pracowników
- Siedziba główna
- Krakow, MA
- Rodzaj
- Spółka prywatna
- Data założenia
- 2004
- Specjalizacje
- Medical devices, Contract Research, Data Monitoring Committees, Core Laboratories IVUS, OCT, MRI, angio, CT, ECG, mhealth, ehealth, algorithms, orthopedics, Ob-Gyn, cardiovascular, oncology, Clinical Evaluation Reports, MDR i PMCF
Lokalizacje
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Główna
Wadowicka 7
Krakow, MA 30-347, PL
Pracownicy KCRI
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Konstantina Konidi
Medical/Pharma Translation Specialist, Marketing Translator/Transcreation Expert ― EN, FR, ES > EL
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kevin cole
en KCRI-COMUNICACION
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Laura Gallego
MClinRes, BSc (Hons), RGN Cardiology Research Manager Freelance CRA
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Jacek Jąkała
Chief Corelab Medical Officer at KCRI
Aktualizacje
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We recently conducted a #BusinessCommunication workshop for our leaders, focused on enhancing collaboration and strengthening leadership skills 🎯. This initiative is part of our ongoing commitment to personal and professional growth, preparing our team for the challenges ahead 🚀. We look forward to the opportunities and growth the future holds. #Leadership #BusinessCommunication #Growth
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Watch Now: MDR Unpacked in 2 Minutes The wait is over! Our video featuring Lidia Strzyż-Baydak is here. In just two minutes, you'll learn: ✔️ How MDR classifies clinical trials for medical devices. ✔️ The key approval requirements for start-ups, CE-marked products, and observational studies. ✔️ Why these changes are crucial for compliance in Europe. Gain actionable insights and make informed decisions. Don’t miss this! 📺 #MDR #MedicalDevices #ClinicalTrials #Compliance #HealthcareInnovation
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The New Frontiers in Interventional Cardiology (NFIC) Workshops 2024 delivered a great program, confirming its status as a cornerstone event for both Polish and international cardiology. We extend our appreciation to the organizers for their dedication to crafting an agenda that highlights advancements and fosters collaboration. Keynote Highlights: Renowned experts shared insights into the latest diagnostics, treatments, and innovations, including: - Flavio Ribichini on renal denervation for hypertension. - Greg L. Kaluza reflecting on a decade of TCT Shark Tank and trends in cardiovascular innovation. - Carlos Collet Bortone Collet on intravascular imaging and physiology for complex PCI guidance. - Adnan Kastrati on dual antiplatelet therapy in ACS and CCS. - Przemysław Mitkowski discussing temporary protection for high-risk cardiac patients. - Jeff Healey on lessons from 20 years of left atrial appendage occlusion. Program Highlights: * A review of cardiogenic shock treatments, featuring updates from the DANGER-SHOCK trial. * Advances in pulmonary embolism management, including catheter-directed thrombolysis and thrombectomy. * Sessions on CHIP interventions, showcasing state-of-the-art approaches to high-risk PCI. * Comprehensive reviews of the latest treatments for valve diseases. Young Cardiologists' Contributions: The PTK Club 30 young cardiologists presented groundbreaking work, reflecting the vibrant future of interventional cardiology. Celebrating its 25th edition, NFIC 2024 continued its legacy of live cases, expert panels, and workshops, advancing interventional cardiology to new heights. Congratulations to all involved for making this event a milestone success! #NFIC2024 #InterventionalCardiology #CardiogenicShock #PulmonaryEmbolism #CHIPInterventions #ValvularHeartDisease #InnovationInCardiology #YoungCardiologists
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Holiday Cheer at KCRI 🎄✨ The festive season is officially here at KCRI! Our team came together to decorate the Christmas tree and add a touch of sweetness to the day by decorating holiday cookies. Sharing smiles and joy, we embraced the spirit of community and togetherness. Wishing everyone a festive and joyful season! #HolidayCheer #FestiveSeason #TeamSpirit #Togetherness #JoyfulMoments
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Navigating the MDR compliance and gathering the clinical evidence 🚨 The landscape of medical device clinical trials underwent significant transformation under the European Union's Medical Device Regulation (MDR) 2017/745. This regulation introduces stricter requirements for clinical evaluations and post-market surveillance, impacting innovators, CE-marked products, and observational studies. 🎥 Stay tuned for the release of our exclusive short video featuring Lidia Strzyż-Baydak, an expert in regulatory compliance. She dives into the latest MDR updates and shares insights on: - Key requirements for clinical trials under MDR. - The evolving landscape for CE-marked devices and observational studies. - Practical tips to stay compliant and efficient in this new era. 📅 The video will be live soon - don’t miss out! Whether you're a medical device innovator, clinical researcher, or regulatory professional, this is a must-watch resource. 📢 Let’s connect and discuss how these changes are reshaping the medical device industry. #MDRCompliance #ClinicalTrials #MedicalDevices #Innovation #RegulatoryAffairs
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💡 #DataManagement: Cleaning and Validation in Clinical Trials Ensuring data quality is a critical aspect of clinical trials. Effective data management is the cornerstone of successful studies, ensuring that collected data is accurate, consistent, and reliable. The process involves two key steps: Data Cleaning: 📌 Detecting and resolving errors, inconsistencies, and missing data. 📌 Correcting duplicate entries or unexpected outliers to ensure a clean dataset. Data Validation: 📌 Ensuring adherence to protocol-defined data collection procedures. 📌 Verifying that key data points are accurately recorded. 📌 Using automated checks in Electronic Data Capture (EDC) systems to flag and address discrepancies. Data cleaning and validation are essential to uphold the integrity of the trial, meet regulatory standards, and provide a solid foundation for meaningful analysis and reporting. #ClinicalTrials #DataManagement #ClinicalResearch #DataQuality
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Advancing Innovation: #PCRLondonValves 2024 This week at the ExCeL London, PCR London Valves 2024 has gathered global experts to explore the forefront of transcatheter valve therapies. The event stands out for its focus on practical skill development, live case discussions, and innovation pathways shaping the future of structural heart care. Key highlights: • Live cases demonstrating advanced TAVI, mitral, and tricuspid techniques. • Hands-on workshops to refine procedural skills. • Emphasis on fostering clinical research and leveraging high-quality clinical data to drive innovation, improve outcomes, and support regulatory pathways for new devices. The conference is a reminder of how collaboration and robust clinical data acquisition are essential for advancing patient care. Let’s connect and discuss your thoughts on clinical research, innovation, and the future of structural heart therapies. #PCRLondonValves #StructuralHeart #ClinicalResearch #Innovation
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#PCRLondonValves 2024 is a key meeting for structural heart disease treatments, bringing together leading specialists in interventional cardiology and cardiac surgery from around the world. 📅 Dates: November 24-26, 2024 📍 Location: EXCEL, London, United Kingdom The program includes live cases, hands-on workshops, and expert discussions focused on transcatheter therapies for valvular heart disease, making it an essential event for staying up to date with advancements in the field. The meeting also highlights exciting developments in clinical research, innovation, and medical technology, offering valuable opportunities for collaboration. 📌 Attending? Connect with us: learnmore@kcri.org #PCRLV #KCRI #ValvularHeartDisease #StructuralHeart #ClinicalResearch
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KCRI ponownie to opublikował(a)
We recently had the fantastic opportunity to connect with leading experts in clinical research at the II Beskidzka Akademia Kardiologii i Innowacji Medycznych! A key highlight of the conference was the Clinical Research Session organized by a multidisciplinary team of specialists. The panelists shared invaluable insights that greatly enhanced the discussions. Robert Dobosz, MSc, MBA, Director of Clinical Trials Solutions at Ryvu Therapeutics, had the pleasure of moderating the session along with Lukasz Partyka and Aneta Sitarska-Haber. The discussion underscored the crucial role of clinical research in advancing medical knowledge, improving patient care, and driving better outcomes. Grupa American Heart of Poland - thank you for this enriching experience. We look forward to future opportunities for collaboration and growth! Photo source: American Heart of Poland #RyvuTX #clinicalresearch #clinicaltrial