OBSERVATIONAL STUDIES AND REGISTRIES: REAL WORLD EVIDENCE

2022-07-05T13:38:23+00:00June 15th, 2022|Categories: Meditrial|Tags: , , , , |

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 [...]

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

2022-07-06T15:23:20+00:00June 8th, 2022|Categories: Meditrial|Tags: , , , , , |

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 [...]

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

2022-07-05T08:43:00+00:00June 1st, 2022|Categories: Meditrial|Tags: , , , , , , , |

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 [...]

NEW OPPORTUNITIES FOR SUCCESSFUL CLINICAL TRIALS.

2022-07-05T08:45:12+00:00May 25th, 2022|Categories: Meditrial|Tags: , , , |

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. [...]

DIETARY SUPPLEMENTS, THE CLINICAL TRIALS ROADMAP.

2022-07-05T13:37:51+00:00May 11th, 2022|Categories: Meditrial|Tags: , , , , , , , |

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 [...]

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

2022-07-05T08:52:21+00:00May 4th, 2022|Categories: Meditrial|Tags: , , , , |

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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