Stay informed with ERGOMED's weekly regulatory updates! 📋 On September 5, 2024, the FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall titled "FDA CBER Virtual Town Hall on Cell Therapy CMC Readiness for Late-Stage INDs." Experts from OTP’s Office of Cellular Therapy and Human Tissue CMC discussed essential aspects of chemistry, manufacturing, and controls (CMC) readiness for late-stage investigational new drug (IND) applications. The event emphasized the importance of CMC data for supporting INDs related to cell therapy and tissue-engineered products—focusing on product safety, quality, and potency. You can watch the recording of the webinar here: https://lnkd.in/djQHrXut At ERGOMED, we are dedicated to staying at the forefront of regulatory updates to help you navigate these evolving requirements. Our regulatory affairs team is ready to support your cell therapy and biologics development efforts, ensuring your CMC readiness for late-stage INDs. 🔗 Learn more about our Chemistry, Manufacturing, and Controls (CMC) services at ERGOMED here: https://lnkd.in/dCbYX8as Stay tuned for more updates from our regulatory affairs experts! #FDA #CBER #CellTherapy #TissueEngineering #Biologics #IND #RegulatoryAffairs #CMCrequirements
ERGOMED
Biotechnology Research
Guildford, Surrey 40,791 followers
Bringing expertise to deliver medicines our world can trust.
About us
Ergomed’s fast-growing services business includes an industry-leading suite of specialist pharmacovigilance solutions, integrated under the PrimeVigilance brand and a full range of high-quality clinical research and trial management services under the Ergomed Clinical Research brand. The Ergomed group employs over 1,800 people and operates out of 24 offices around the world, providing its services to researchers and patients in around 100 countries globally. Our Ergomed Clinical Research business was founded in 1997 and provides high-quality clinical research and trial management services globally and across all trial phases (I to IV), specialising in oncology and rare disease trials. We use innovative site-support services which focus on enhancing patient recruitment and engagement, with a strong heritage in Europe and the USA. PrimeVigilance is a global leader in pharmacovigilance and specialised multi-lingual medical information services. Since 2008, the PrimeVigilance business has supported pharmaceutical, biotechnology and genetics companies in managing the global safety of their products, all the way from clinical trial to post-marketing. Our pharmacovigilance services include case processing, signal and risk management, pharmacoepidemiology, audits, training, advisory literature services, medical information and QPPV.
- Website
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http://www.ergomedcro.com/
External link for ERGOMED
- Industry
- Biotechnology Research
- Company size
- 1,001-5,000 employees
- Headquarters
- Guildford, Surrey
- Type
- Privately Held
- Founded
- 1997
- Specialties
- Clinical Development, Trial Management, Pharmacovigilance, Drug Development, Pharmaceutical Services, Global Clinical Trials, Clinical Research, Contract Research Organization, Oncology Clinical Trials, Rare Disease Clinical Trials, Drug Development Expertise, Proof-of-Concept Studies, Late-Stage Clinical Programs, Patient Recruitment and Retention, Site Management and Monitoring, Clinical Project Management, Clinical Data Management, Phase II-IV Trials, Neurology Clinical Trials, and Patient-Centricity
Locations
Employees at ERGOMED
Updates
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ERGOMED & PrimeVigilance are live at #ESMO24 in beautiful Barcelona, Spain! 📍 Booth #657 is where you can find our expert team ready to share insights on how ERGOMED’s tailored oncology solutions, including our specialization in Head & Neck cancers, can support your clinical trials. See you there! #OncologyResearch #HeadAndNeckCancers #ClinicalTrials #CRO #ESMO2024 #Barcelona
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ERGOMED reposted this
Greetings from me and Antonia Schultze from ESMO - European Society for Medical Oncology conference in Barcelona! You can find us at booth #657 and dicuss how PrimeVigilance and ERGOMED can support managing oncology clinical studies. See you! #ergomedgroup #primevigilance #cro #pharmacovigilance #clinicalsafety
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🌟 ERGOMED Clinical Research is excited to attend Outsourcing in Clinical Trials Southern California 2024 in San Diego, CA, from September 24-25! If you’re attending, be sure to visit us at Booth #10! Our expert team, including Julia Day (Senior Director, Business Development) and Chris Henne (Director, Business Development), will be there to answer your questions and discuss how Ergomed’s customized solutions can support your clinical trials. Whether you’re looking for expertise in patient recruitment strategies, regulatory affairs, or project management, ERGOMED is committed to helping you navigate the complexities of clinical research. Let’s drive success together! 📅 Maximize your time at the event—schedule a meeting with our experts today to learn how we can support your clinical trial needs: https://lnkd.in/dcnQzTAD We look forward to connecting with you at #OCTSoCal24! #ClinicalResearch #ClinicalTrials #Ergomed #SanDiego #OCTSoCal
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Advancing a Complex Clinical Trial Ahead of Schedule! 📢 ERGOMED is proud to announce that our client's complex clinical trial has advanced ahead of schedule! Navigating a complex and challenging study protocol with stringent timelines requires a structured, high-quality, flexible, and proactive approach. Our collaboration with the sponsor during the early planning stages and the unified efforts of our feasibility, start-up, regulatory, medical, site management, and operational teams were critical to the study's success. 🚀 Read the Case Study: https://lnkd.in/e69p9vh6 #ClinicalResearch #ComplexClinicalTrials #Oncology #SuccessStory
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Our clinical trials in neuroscience span a wide geographic area, ensuring diverse patient populations and robust data. This global reach enables us to offer unparalleled insights and solutions tailored to various regions. Learn how ERGOMED CRO is dedicated to advancing medical science and improving patient outcomes across a wide range of neurological conditions: https://lnkd.in/eg3bPW2b #ClinicalResearchServices #OncologyCRO #neuroscience
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ESMO Congress 2024 kicks off tomorrow! We’re excited to announce that the ERGOMED Group will be attending the ESMO Congress in Barcelona, Spain, from 13-17 September 2024! 📍 Join us at Booth #657 to connect with our team of experts and learn how Ergomed’s oncology solutions, particularly in Head & Neck cancers, can support your clinical trials. We’re ready to help you with patient recruitment strategies, regulatory navigation, and seamless project management to overcome the challenges of oncology research. Our attending team includes: - Colin Hayward, MD - Head, Medical Science - Dusan Markovic, MD - VP, Global Medical Affairs - Sonja Pons, RN - Director of Strategy, Oncology - Juliet (Jules) Moritz - Senior VP, Strategic Solutions & Patient Centricity - Nikola Strumberger, MD - Senior VP, Commercial Operations - Antonia Schultze - Senior Director, Business Development - Olivija Sileike - Director, Business Development - Katarina Đogatović (ex Stamatović) - Senior PV Physician - Bojana Milasinovic - Associate Medical Director Don't miss out—schedule a meeting with our oncology experts in advance to discuss how we can drive success in your clinical research: https://lnkd.in/dMvFUNxp #ESMO24 #OncologyResearch #HeadAndNeckCancers #ClinicalTrials
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Elevate Your Engagement with Patient Advocacy Organizations (PAOs)! 🗓️ Join ERGOMED Clinical Research on October 16th for an exclusive webinar focused on the powerful impact Patient Advocacy Organizations (PAOs) have on patient-centered drug development. This is your chance to discover how to foster trustworthy, ethical, and meaningful partnerships with PAOs that can revolutionize clinical trials and ensure patient needs are prioritized every step of the way. Our experts, Paula Orandash & Goran Vasović, will share their perspectives on bridging the gap between pharma and patient advocacy to drive transformative healthcare solutions. 🔗 Don’t miss out! Register now:https://lnkd.in/dueKArZa #Webinar #PatientCentricity #Pharma #ClinicalTrials #PAO #Ergomed #PatientEngagement
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🌉 Live from Clinical Trials in Rare Diseases 2024! ERGOMED Clinical Research is excited to be part of this event in San Francisco. Stop by Booth #9 today to explore how our tailored solutions are designed to support your rare disease studies and help you navigate the complexities of clinical trials. Meet our experts, including Juliet (Jules) Moritz (Senior VP, Strategic Solutions & Patient Centricity), Julia Day (Senior Director, Business Development), and Chris Henne (Director, Business Development). There’s still time to connect with us and discuss how we can help drive success in your clinical programs! #ClinicalResearch #RareDiseases #OrphanDrugs
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Join ERGOMED Clinical Research this week at the ESMO - European Society for Medical Oncology 2024 in Barcelona! We are very excited to announce that our Vice President of Global Medical Affairs, Dusan Markovic, has co-authored an abstract, "Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy." Take advantage of this opportunity to connect with industry leaders and gain valuable clinical research insights. We look forward to seeing you there! #Ergomed #ClinicalResearch #OncologyCRO #RareDiseases
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