e.alvarado2022-08-04T13:36:16+00:00August 3rd, 2022|Categories: Meditrial|
Cyber attacks can cripple the operation of systems in any sector. However, in the case of health care, such paralysis can be a matter of life and death. Recently, medical device security has become a global concern and a [...]
e.alvarado2022-08-04T13:42:31+00:00July 27th, 2022|Categories: Medical Research, Meditrial|
Health care is connected to every aspect of society. We rely on highly qualified physicians to keep us healthy by using their vast knowledge and progressively more advanced clinical tools and resources. But physicians around the world involved in [...]
e.alvarado2022-08-04T13:43:59+00:00July 20th, 2022|Categories: Medical Research, Meditrial|Tags: Case Report Design, Clinical, Clinical Data Management Practices, Clinical Data Management Software, Data Management, Serious Adverse Events, SOPs, Study Setup|
When novel drugs or medical devices are evaluated in clinical trials, the data generated in this process is called clinical data. Improving the use of technology in clinical trials is now a prime opportunity for the life sciences industry. [...]
e.alvarado2022-08-04T14:05:47+00:00July 6th, 2022|Categories: Meditrial|Tags: Clinical Trial, Estimand, ICH, PRO, Study Planning|
Edited by Dr. Monica Tocchi, Meditrial medical director. The organization called ICH (International council for harmonization of technical requirements for pharmaceuticals for human use) is a global organization that unites regulatory authorities and the pharmaceutical industry in the common [...]
e.alvarado2022-08-04T14:21:10+00:00June 28th, 2022|Categories: Meditrial|Tags: Clinical Trial, Devices, GCP, Good Clinical Practice, IN-VITRO, IVD, IVDR, Medical Devices|
Atty. Alessia Nuciari, director of compliance Meditrial. The in vitro diagnostics industry has undergone a substantial transformation. IVDR Regulation 746/2017, published in May 2017 and applied from May 26, 2022, introduced major changes in the industry. The main [...]
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. [...]
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