3 Bold Moves in the EU’s Life Sciences Strategy to Dominate Global Innovation by 2030
On July 2, 2025, the European Commission announced a bold new initiative to position Europe as the global leader in life sciences by 2030. Presented under the Communication titled “Boosting Biotechnology and Biomanufacturing in the EU”, this strategy aims to unlock the full potential of the life sciences ecosystem in Europe, ensuring the continent remains […]
5 Transformative Changes in ICH E6(R3) That Will Redefine Clinical Trials
Understanding ICH E6(R3): The Evolution of Good Clinical Practice and Its Impact on Clinical Trials The Good Clinical Practice (GCP) guidelines, developed by the International Council for Harmonisation (ICH), serve as the international ethical and scientific standard for designing, conducting, recording, and reporting clinical trials involving human participants. These guidelines are essential for ensuring the […]
Optimizing Men’s Health: Clinical Breakthrough in Chronic Bacterial Prostatitis Treatment
In recent years, clinical research has placed growing emphasis on health conditions uniquely affecting men, addressing long-overlooked issues such as testosterone deficiency, erectile dysfunction, and prostate diseases. Among these, Chronic Bacterial Prostatitis (CBP) is emerging as a condition of high interest due to its prevalence, recurrence, and negative impact on quality of life. Men’s health […]
Alzheimer’s Disease Clinical Trials | 1MED MedTech Innovation
Advancing Alzheimer’s Care Through Clinical Trials: How 1MED Supports Innovation in Medical Devices Discover how 1MED advances Alzheimer’s care through clinical trials of innovative medical devices for diagnosis, sleep safety, and daily life support. Alzheimer’s disease is one of the most pressing health challenges of our time. As a progressive neurodegenerative condition, it impacts memory, […]
Enhancing Ileo-colo-rectal Mesalamine Levels for Better Ulcerative Colitis Care
Ulcerative colitis (UC) is a chronic, relapsing inflammatory bowel disease (IBD) that primarily affects the colon and rectum. Characterized by symptoms such as abdominal pain, diarrhea, and rectal bleeding, UC presents significant challenges for both patients and healthcare providers. Its global incidence is rising steadily, particularly in newly industrialized countries, pointing to a combination of […]
Advancing Innovation in Cardiopathology Research: 1MED’s Role in the Quantum Perfusion Cannula Study
Cardiovascular disease remains the leading cause of death globally – and the demand for safe, effective, and innovative technologies has never been greater. At 1MED, we are proud to support transformative clinical research in cardiology, from high-risk interventions to cutting-edge mechanical circulatory support systems. One such initiative is our full clinical and regulatory oversight for […]
Smart Solutions for Clinical Data Collection – Do I really need a Trial?
Introduction The introduction of Regulation (EU) 2017/745 (MDR) has brought a seismic shift in how medical device manufacturers must approach clinical evidence. MDR places the burden on manufacturers to provide an adequate level of clinical evidence proportionate to the device’s risk profile. While traditional clinical trials remain the gold standard, the MDR also recognizes alternative […]
Navigating Swiss Regulations: What Swissdamed Means for Economic Operators
SWISSMEDIC, the Swiss Agency responsible for the authorization and oversight of medicinal products and medical devices, recently announced the launch of “Swissdamed,” a new platform for medical devices, beginning in late August 6, 2024. The rollout is occurring in phases, with the initial release of the “Actors” module, which allows economic operators to register through […]
Pediatric Research for a Healthier Start: Spotlight on Infantile Colic and Clinical Trials
World Health Day Spotlight: Pioneering Pediatric Research for a Healthier Start and Advancing Pediatric Health Through Clinical Trials on Infantile Colic in Newborns Every year on April 7th, World Health Day draws global attention to pressing health issues and celebrates milestones in healthcare and honor global efforts to improve healthcare access and outcomes. This year, […]
Italian CRO, LB Research, Joins the 1MED Group
1MED today announces that LB Research is now part of the 1MED Group. Established in 2007 and based in Como, Italy, LB Research is a full-service contract research organisation providing clinical trial management across all clinical product life cycle phases. LB Research operates with a highly skilled team of 24 professionals and maintains a diverse […]