FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]

UK: MHRA supports generating RWE in clinical trials through digital solutions

2024-02-29T16:25:13+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: , , , , |

UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions. MHRA exaplained that real-world data source in [...]

US: FDA launches the Digital Health Center of Excellence

2024-02-29T16:51:55+00:00October 20th, 2020|Categories: Clinical Trial, USA|Tags: , , , , |

The U.S. Food and Drug Administration recently launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). "The launch of the Digital Health Center of Excellence is an important step in furthering the [...]

EU: EMA supports digital health technologies in clinical trials

2020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: , , , , |

Digital health technologies  are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]

Meditrial CMO – Dr. Monica Tocchi joins the Venturelab Expert panel

2024-02-29T10:16:35+00:00June 17th, 2020|Categories: Clinical Trial, Compliance, Innovation, Regulatory, Software, Switzerland|Tags: , , , , , |

Dr. Monica Tocchi, CMO and Founder of Meditrial joined the Innosuisse Start-up Training program designed by Venturelab, as a member of their Expert panel. The panel is composed of successful founders, leading academic and industry partners that bring the [...]

“Win KOLs and work with partners” – virtual training by Dr. Monica Tocchi for VentureLab

2024-02-01T14:12:57+00:00May 27th, 2020|Categories: Europe, Innovation, Switzerland|Tags: , |

On 4th June 2020, Dr. Monica Tocchi, Founder and CMO of Meditrial will hold a virtual training hosted by Venturelab  – a swiss startup training program commissioned by Innosuisse . This intensive course entitled “Win KOLs and work with partners” is [...]

Meditrial provides rapid workflows to rescue clinical trials during pandemic

2024-02-29T13:46:29+00:00March 19th, 2020|Categories: Clinical Trial, Covid-19, Europe, Innovation|Tags: , , , , |

As the COVID-19 emergency impacts all healthcare sectors, Meditrial provides rapid tools to help industry and researchers rescue their clinical trials. Safeguard of patients’ safety is the key concern, but also avoiding the compromise integrity of important studies due [...]


2024-02-29T10:24:48+00:00March 17th, 2020|Categories: Clinical Trial, Covid-19, Europe, Innovation|Tags: , , , , |

As your reliable and trustworthy partner, we at Meditrial, have taken extraordinary measures to be always at your side and support you and your peers during the time of the COVID-19 emergency. That´s why we set up a Meditrial FREE [...]

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