e.alvarado2022-07-05T08:28:58+00:00June 22nd, 2022|Categories: Meditrial|Tags: CLINICAL PRACTICE, Devices, EDC, EU-MDR 2017/745, MDR, Medical Devices, PMCF, PMS, Post-market clinical follow-up, Post-market surveillance, Postmarketing, Surveillance|
After more than 20 years, new legislation, the "Medical Device Regulation" (EU-MDR 2017/745), has come into force in Europe. The triggers for the initiation and implementation of this European law, which is much stricter than previous directives, were scandals related [...]
e.alvarado2022-07-05T13:38:23+00:00June 15th, 2022|Categories: Meditrial|Tags: Clinical Trial, Medical Devices, OBSERVATIONAL STUDIES, REAL WORLD EVIDENCE, RWE|
Dr. Paola Antonini, Meditrial scientific director. If well designed, observational studies and registries produce treatment effect data comparable in importance to those in randomized controlled trials,[1] generating information missing in traditional interventional studies and real-world data to support marketing [...]
e.alvarado2022-07-06T15:23:20+00:00June 8th, 2022|Categories: Meditrial|Tags: Clinical Trial, DECENTRALIZED TRAILS, EDC, Medical Devices, Patient, PRO|
Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your [...]
e.alvarado2022-07-05T08:43:00+00:00June 1st, 2022|Categories: Meditrial|Tags: Authorized European Representative, Authorized Representative, Device Vigilance, Incident, MDV, MEDICAL DEVICE VIGILANCE, Medical Devices, UNDERREPORTING|
Italy has recently instituted substantial changes in national regulations on medical device vigilance in order to align our procedures with European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics. As of Oct. 16, 2022, the new rules [...]
e.alvarado2022-07-05T08:45:12+00:00May 25th, 2022|Categories: Meditrial|Tags: Clinical Trial, DECENTRALIZED STUDIES, PATIENT RECRUITMENT, RETENTION CHALLENGES|
The challenge of recruiting suitable patients into clinical trials has always been a significant obstacle to drug and medical device development programs. The difficulty of generating evidence delays the introduction of new medical interventions and results in high costs. [...]
e.alvarado2022-07-05T08:49:15+00:00May 17th, 2022|Categories: Meditrial|Tags: Clinical Trial, Covid-19 vaccines, Drug Safety, Eudamed, PAES, PASS, POST-AUTHORIZATION STUDIES, SAFETY|
Over the course of two years of the pandemic, there have been heated debates about the safety and efficacy of the anti-Covid-19 vaccines. Even today, after more than 7 billion doses administered, issues continue to emerge about the available clinical [...]
e.alvarado2022-07-05T13:37:51+00:00May 11th, 2022|Categories: Meditrial|Tags: Clinical Development, Clinical Trial, DIETARY SUPPLEMENTS, Food supplements, Functional foods, HOMEOSTASIS, NUTRACEUTICAL, Regulation 1924/2006|
Paola Antonini, Meditrial Scientific Director. Due to the pandemic and the information shared on social media, the increased attention of individuals to their own health and well-being has led to a considerable increase in the consumption of food supplements [...]
e.alvarado2022-07-05T08:52:21+00:00May 4th, 2022|Categories: Meditrial|Tags: Clinical Development, Clinical Trial, DRUGS, Medical Devices, Pharmaceuticals|
Clinical development is a term traditionally used to define the entire process of bringing a new drug or medical device to market. It includes a pre-clinical phase to support human use and a clinical trial phase on patients, in compliance [...]
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