Tigermed EMEA

This Thanksgiving, we pause to thank our incredible Tigermed colleagues, clients, investigators, and partners around the world for your trust, dedication, and collaboration. Together, we are advancing clinical research and helping bring innovative therapies to patients and families globally — we are truly grateful for every step we’ve taken together. Wishing everyone who celebrates a warm, healthy, and meaningful Thanksgiving. #Thanksgiving #Gratitude #Tigermed #ClinicalResearch #CRO #GlobalTeam

How evidence, regulation and innovation shape safer technologies — and how CROs like Tigermed EMEA support this process. Medical devices are evolving faster than ever: AI-powered diagnostic systems, connected wearables, implantable sensors, robotic surgical tools. But no matter how advanced the design, a device becomes truly valuable only when its safety and performance are demonstrated through clinical evidence. https://lnkd.in/g48axqNr

Lenacapavir – A New Era in HIV Prevention. Recent Approvals and Global Impact HIV prevention is entering a transformative phase with the approval of lenacapavir, the first once-every-six-months injectable PrEP (pre-exposure prophylaxis). This breakthrough has the potential to reshape global prevention strategies by offering an effective and convenient alternative for individuals at increased risk of HIV infection. Official Approval Dates FDA (United States): June 18, 2025 EMA – Positive Opinion: July 25, 2025 Final EU Market Authorization: August 26, 2025 These milestones come at a crucial moment, as the world continues to report approximately 1.3 million new HIV infections each year, with more than 40 million people currently living with HIV worldwide. Why Lenacapavir Matters Provides long-acting protection with just two injections per year Significantly improves adherence to PrEP, overcoming challenges of daily oral regimens Enhances access to prevention, especially in settings with limited healthcare resources Has the potential to dramatically reduce new infections and accelerate global HIV control goals A Message to the Medical and Research Community The approval of lenacapavir highlights the power of innovation in infectious disease prevention and reinforces the importance of sustained investment in clinical research. For pharmaceutical companies, CROs, and research centers, this marks the beginning of a new generation of long-acting therapeutics with far-reaching implications for public health. #HIVPrevention#TigermedEMEA

  What Sponsors, Researchers and CROs Need to Know — Insights from Tigermed EMEA   The U.S. Food and Drug Administration (FDA) continues to influence global clinical research through updated guidances, new accepted endpoints, and evolving regulatory expectations. For sponsors and research partners operating internationally, staying aligned with the latest FDA directions is essential for designing high-quality, inspection-ready studies. https://lnkd.in/gsZ3bYey

FDA Approves Revumenib — A New Milestone in Leukemia Research Insight by Tigermed EMEA, your trusted clinical development partner On October 24, 2025, the FDA approved Revumenib (Revuforj®), marking a breakthrough moment in the treatment of aggressive acute leukemias. This is the first menin inhibitor ever approved, opening a completely new chapter in targeted hematology therapies. Why this approval matters Approved for adult and pediatric patients (≥1 year) with relapsed or refractory acute leukemia carrying KMT2A translocation or NPM1 mutation. Targets the critical menin–MLL pathway, directly disrupting a key driver of leukemic proliferation. Backed by encouraging clinical results from the AUGMENT-101 trial, addressing patient populations with extremely limited therapeutic alternatives. A step forward for precision oncology This approval highlights the importance of genomic profiling and biomarker-driven study design. Identifying mutations such as NPM1 or KMT2A becomes essential in guiding treatment and advancing personalized medicine. Perspective from Tigermed EMEA At Tigermed EMEA, we closely monitor scientific and regulatory developments that reshape oncology research. Our teams support global sponsors in: - Running complex hematology & rare-disease trials - Implementing biomarker-based and adaptive study designs - Accelerating recruitment in high-need therapeutic areas - Ensuring regulatory compliance across EU and global regions Breakthrough approvals like Revumenib demonstrate the growing need for innovative clinical trial strategies, strong molecular expertise, and robust global execution — domains where Tigermed and Tigermed EMEA excel. #TigermedEMEA#GlobalClinicalTrials#OncologyInnovation#PrecisionOncology

Adaptive Clinical Trials in Oncology: A New Standard for Developing Personalized Therapies Oncology is today one of the most advanced and complex therapeutic areas, and the development of new treatments requires research models capable of keeping pace with scientific progress. Immunotherapy, cell therapies, combination treatments, and the use of genomic biomarkers are creating a growing need for study designs that are flexible, efficient, and strongly data-driven. In this context, adaptive, basket, umbrella, and platform trials are becoming essential for accelerating oncological innovation. These models enable: Real-time optimization of treatment arms based on interim data Faster patient recruitment, aligned with specific mutations or tumor characteristics Reduced development timelines and improved operational efficiency Higher probability of success through more precise patient stratification Earlier access to innovative therapies for eligible patients At Tigermed EMEA, we address these requirements through a combination of scientific expertise, operational capability, and advanced technological solutions: - Implementation of adaptive protocols in oncology - A strengthened network of top oncology centers across the EU and EEA - Digital infrastructure for real-time data capture and analysis - Statistical, medical, and operational support for complex multi-arm, multi-region studies In an era where oncology is becoming increasingly precise and personalized, clinical trials must evolve to be equally agile and intelligent. Tigermed EMEA — your trusted partner for the development of next-generation oncology therapies.

🌍 World Children’s Day – A reminder of why clinical research matters Today, on World Children’s Day, we honor the importance of protecting children’s health and future. At Tigermed EMEA, we are committed to advancing clinical research that supports safer, more effective therapies for the next generation. Investing in pediatric studies means investing in healthier tomorrows. Let’s continue building a world where every child has access to innovation, care, and hope. #WorldChildrensDay #ClinicalResearch #PediatricStudies #TigermedEMEA #FutureOfHealth

Clinical Trial Safety Under CTR: What CROs Need to Know in 2025 Under the EU Clinical Trials Regulation (CTR), safety reporting has entered a fully harmonized era — and CROs must adapt quickly. What changed: CTR now requires all SUSAR submissions to be reported exclusively via EudraVigilance, using ICSR E2B(R3) and EDQM terminology — eliminating parallel national submissions. At the same time, the Annual Safety Report (ASR) replaces the former “DSUR” terminology within the CTR framework, with detailed expectations outlined in the recently updated CTIS Sponsor Handbook. Impact for CROs: Integrating pharmacovigilance databases with CTMS/EDC is now essential to ensure clean SUSAR flows, correct E2B(R3) mapping, updated ASR procedures, and clearly defined timelines and responsibilities for annual aggregate reporting. What should CROs do now? — A short action list 1-Complete the CTIS transition for all ongoing trials continuing beyond 31 January 2025 — including access rights and transition dashboards. 2-Strengthen transparency governance: CCI matrices, “publishable” document templates, and targeted training for medical/regulatory teams. 3-Standardise hybrid DCT operations: SOPs for home visits, eConsent, identity verification, digital devices, and IMP courier/traceability workflows. 4-Implement AI governance: algorithm registry, validation processes, performance monitoring, and clear “human-in-the-loop” oversight. 5-Align clinical PV with CTR: full integration with EudraVigilance, E2B(R3), ASR, and a harmonised QMS framework. At Tigermed EMEA, we support sponsors in navigating these regulatory shifts with compliant systems, optimised workflows, and end-to-end clinical operations aligned with CTR 2025 expectations.

Tigermed & Tigermed EMEA – a step forward in strengthening global leadership in clinical research In recent months, Tigermed and its teams — including Tigermed EMEA — have marked a series of strategic developments that reinforce the company’s position as one of the most influential global players in the CRO industry.  Key strategic highlights worth noting:  Expansion in Asia-Pacific through the acquisition of Micron (Japan) The completion of the Micron acquisition — a CRO specialized in medical imaging — brings advanced expertise and direct contributions to the approval of more than 40 drugs. This step enhances Tigermed’s ability to lead complex imaging-driven studies and strengthens its presence in Japan and the broader APAC region. Outstanding ESG performance – MSCI AAA rating The highest MSCI ESG rating validates Tigermed’s commitment to: • 100% ethics training for employees, • significant investments in professional development (nearly 100 hours/employee in 2024 alone), • strict ethical standards for suppliers and partners. A model of corporate responsibility and governance in the CRO industry.  International recognition – Forbes China Go-International Top 30 Tigermed has been selected as one of the most representative globalized Chinese companies, thanks to its expansion across more than 180 offices worldwide and a team of over 10,000 professionals. Strengthening the global infrastructure – Launch of a CDMO facility in Pennsylvania (USA) – FDA audits with “no findings” for the bioanalytical labs in Suzhou and Shanghai – ~12% growth in SMO activities in the first half of 2025  Solid financial performance in 2025 Quarterly revenues of ~1.78 billion RMB and profit of ~637 million RMB for Q3 highlight a rebound and stability in a competitive global environment. The role of Tigermed EMEA Tigermed EMEA actively contributes to the expansion and integration of operations across Europe, the Middle East, and Africa by ensuring: • operational quality aligned with European regulatory standards, • collaboration with regional pharma and biotech leaders, • acceleration of multi-regional clinical trials, • connection of European ecosystems with Tigermed’s global infrastructure. EMEA represents one of the company’s most dynamic growth regions and a primary driver of its “Go-International” strategies.  Conclusion Tigermed and Tigermed EMEA demonstrate a rare combination of scientific rigor, operational excellence, and global vision. From investments in people and infrastructure to international recognition and financial performance, the company reinforces its status as a trusted global partner for the pharmaceutical and biotech industries. A powerful example of leadership in the era of globalized clinical research. #tigermed#tigermedemea

 Artificial Intelligence and Clinical Trials – Essential Partners in the Fight Against Breast Cancer A New Perspective on Prevention Breast cancer remains the leading cause of cancer-related death among women, with more than 2.3 million new cases annually worldwide (WHO, 2024). https://lnkd.in/guvUh8fA