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MEDITRIAL BLOG

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308, 2022

CYBERSECURITY FOR MEDICAL DEVICES: PROTECTING YOURSELF FROM RISKS WITH BLOCKCHAIN

August 3rd, 2022|Categories: Meditrial|0 Comments

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 focal point for regulators and [...]

2707, 2022

CAREERS IN CLINICAL DEVELOPMENT: PHYSICIANS OF 2030

July 27th, 2022|Categories: Medical Research, Meditrial|0 Comments

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 developing new modes of care [...]

2007, 2022

SOLVING THE DATA MANAGEMENT CHALLENGE IN DIGITAL CLINICAL TRIALS

July 20th, 2022|Categories: Medical Research, Meditrial|Tags: , , , , , , , |0 Comments

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. Digital trial processes enable us [...]

607, 2022

CLINICAL TRIAL DESIGN: THE REVOLUTION OF NEW STATISTICAL PRINCIPLES

July 6th, 2022|Categories: Meditrial|Tags: , , , , |0 Comments

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 goal of ensuring the development [...]

2806, 2022

CLINICAL EVIDENCE FOR IVDs: THE NEW GOOD CLINICAL PRACTICES

June 28th, 2022|Categories: Meditrial|Tags: , , , , , , , |0 Comments

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 changes designate a strengthened system [...]

1506, 2022

OBSERVATIONAL STUDIES AND REGISTRIES: REAL WORLD EVIDENCE

June 15th, 2022|Categories: Meditrial|Tags: , , , , |0 Comments

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 authorization. WHAT DESIGN? Observational [...]

806, 2022

THE NEW ROLE OF THE PATIENT AS AN ACTIVE PLAYER IN CLINICAL TRIALS

June 8th, 2022|Categories: Meditrial|Tags: , , , , , |0 Comments

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 participation and to introduce tools [...]

106, 2022

ITALY’S NEW DEVICE-VIGILANCE NETWORK: HOW TO PREPARE FOR IT

June 1st, 2022|Categories: Meditrial|Tags: , , , , , , , |0 Comments

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 of the March 21, 2022 [...]

2505, 2022

NEW OPPORTUNITIES FOR SUCCESSFUL CLINICAL TRIALS.

May 25th, 2022|Categories: Meditrial|Tags: , , , |0 Comments

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. In a new Covid-19 environment, [...]

1105, 2022

DIETARY SUPPLEMENTS, THE CLINICAL TRIALS ROADMAP.

May 11th, 2022|Categories: Meditrial|Tags: , , , , , , , |0 Comments

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 such as vitamins, minerals, immune [...]

405, 2022

CLINICAL DEVELOPMENT OF DRUGS AND MEDICAL DEVICES: AN OVERVIEW OF THE MOST INNOVATIVE AND INTERESTING ASPECTS.

May 4th, 2022|Categories: Meditrial|Tags: , , , , |0 Comments

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 with current regulations. But today, [...]

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