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.alvarado2022-07-05T13:38:23+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.alvarado2022-07-05T08:45:12+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 [...]
adminMTE_04792023-03-31T09:04:26+00:00May 6th, 2021|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, Germany, MDR, Regulatory|
The medical device regulation EU 2017/745 allows Member States some adjustments for local implementation. If you sponsor a trial in Germany, you must learn what are the new ordinances and guidelines for the implementation of the MDR. [...]
adminMTE_04792023-03-31T09:12:27+00:00April 22nd, 2021|Categories: Clinical Trial, Europe, MDR|Tags: Austria, Clinical Trial, Europe, IVDR, MDR|
The Austrian Federal Office for Safety in Health Care (BASG) gave information on a new validation process during the transition to the MDR which will come into force in May 2021.Meditrial manages several studies in Austria and has direct connections [...]
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