TMC Pharma Services Ltd

BIO-Europe is just one week away! The following team members will be attending from TMC: Simon Estcourt, CEO Victoria Datsenko, MD, PhD, VP Clinical Services Chris Wells, Senior Director of Business Development As a global clinical research organisation (CRO), we're excited about connecting with biotech/pharma delegates and discussing their drug development needs. If you’d like to arrange a one-to-one meeting with Simon, Victoria or Chris, drop them a message! #BIOEurope #Networking #RareDiseases #RareDiseaseCommunity #LifeSciences EBD Group

A CRO is a company contracted by a pharmaceutical, biotech or medical device manufacturer to manage clinical research and other services to support drug discovery and development.  Key responsibilities include: ✅ Clinical trial design and planning. ✅ Navigating the complex regulatory requirements needed to start and run clinical studies. ✅ Patient recruitment and site management. ✅ Data collection and management. ✅ Continuous drug safety monitoring. ✅ Preparing reports and regulatory submissions. We're a CRO, but at TMC we’re more than just a CRO. Read our latest blog to find out why. ⬇️ #ClinicalResearchOrganisation #CRO #RareDiseases #ClinicalStudies #ClinicalTrials

The World Orphan Drug Congress Europe is this week! We always look forward to this annual conference, which provides us with the opportunity to meet with prospective biotech and pharmaceutical companies to discuss their drug development needs. Chris Wells, our Senior Director of Business Development, and Alison Shaw, MSc, our Senior Director of Regulatory Services, will be attending from the TMC team. If you’d like to find out more about our services and explore how our expert team can support you in your drug development programme, drop Chris or Alison a message to schedule a meeting. #WODC #WorldOrphanDrugCongress #RareDiseases #RareDiseaseCommunity #PharmaNetworking

Have you read our article in Research Quality Association (RQA)’s QUASAR magazine about the role of pharmacovigilance in oncology drug trials? In the piece, our experts — Marcelo Alexandre Costa Vaz, Lucy Fulford-Smith and Quentin Clarke — discuss the challenges sponsors and the clinical research organisations, that work on behalf of them, face in this area, as well as the best practices to adopt for PV in oncology. Get the link to the article in the comments below. ⬇️ #Pharmacovigilance #Oncology #RareDiseases #DrugTrials #CRO

Cumulatively, rare diseases are not so rare at all. There are approximately 300 million people living with rare diseases to date and 7,000 diagnosable rare conditions worldwide*.  Yet, there's still a significant gap when it comes to medical research for rare diseases. Why? Funding and investment are the primary reasons behind this gap, argues our CEO, Simon Estcourt. In this article for RARE Revolution Magazine, he discusses the current considerations for conducting clinical trials for rare diseases, approaches for overcoming challenges and how he thinks the rare disease landscape will evolve in the coming years… *The Lancet #RareDiseases #CRO #ClinicalResearch #MedicalResearch #ClinicalTrials https://lnkd.in/eq_TQtwA

RARE Revolution Magazine is a vital communications line of support for families struggling to find life-saving/life-giving treatment solutions for their loved ones. Our CEO, Simon Estcourt, provides insight on page 60 of this edition, on the future of the rare disease landscape and the value that clinical research organisations, such as TMC Pharma Services Ltd, can provide in this specialist area. #RareRevolution #CRO #ClinicalResearchOrganisation #TMC #RareDisease

Today is Stem Cell Awareness Day, which is observed annually on the second Wednesday of October. Stem cells can be sourced from various tissues, including: 🟠 Bone marrow 🔵 Umbilical cord blood 🟢 Adult tissues Stem cell donations and research offer great potential for new medical treatments and therapies. There are a number of charities doing excellent work in this area, so check them out for more information: Anthony Nolan DKMS UK The UK Stem Cell Foundation National Stem Cell Foundation Please share any other excellent stem cell charities you know to show your support! #StemCellAwarenessDay #StemCells #StemCellResearch #RareDiseases #MedicalResearch

Are you a non-EU/EEA biotech/pharma company facing significant regulatory challenges? From 1 January 2025, the European Medicines Agency (EMA) is implementing the EU Regulation 2024/568 on fees for regulatory submissions. This change will result in a significant increase in some of the fees payable to the EMA for scientific assessment of a medicinal product for the application of a marketing authorisation, variation or authorised product. As an established EU/EEA-based marketing authorisation holder with SME status, TMC can be your EU/EEA representative, ensuring compliance with all local regulations whilst securing substantial discounts on EMA fees.    Here’s why you should choose TMC… ✅ Our experienced team provides expert guidance throughout the entire regulatory process, from pre-approval to post-market surveillance. ✅ We offer a comprehensive solution for all your regulatory needs and our team has a proven track record of successful regulatory submissions. ✅ You can also benefit from our partnerships with leading providers and access cutting-edge serialisation (FMD) and regulatory information management systems. Contact our team today to learn how TMC can help you navigate the complex regulatory landscape and bring your products to market efficiently and cost-effectively. 📞 +44 1252 842255 📧 regulatory.services@tmcpharma.com #RegulatorySubmissions #EMA #MarketingAuthoriationHolder #SME

As we approach BIO-Europe, I am excited about the opportunity to engage with the global life sciences community. Our clinical research organisation,TMC, is dedicated to advancing innovative life-saving treatments for rare diseases. I welcome the chance to connect and explore potential collaborations. Informa Connect

If you still haven’t made the transition from the Clinical Trial Directive (CTD) 2001/20/EC to the European Medicines Agency's (EMA) EU Clinical Trial Regulation (CTR) 536/2014, you have just UNDER TWO WEEKS until the recommended submission timeline of 16 October 2024. Our in-house team of regulatory experts are ready to provide you with guidance and support to help you navigate the transition and ensure you make submission, in order to meet the cut-off deadline of 31 January 2025. Contact us today at regulatory.services@tmcpharma.com to find out how we can assist you. #EUCTR #ClinicalTrials #CTR #ClinicalTrialsRegulation #EMA