Germany: BfArM Recommendations for clinical trials with medical devices during the COVID-19 pandemic

2024-02-26T11:12:52+00:00March 27th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory, Western Europe|Tags: , , , |

On March 26, 2020, the BfArM published "Additional recommendations on the European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic " for clinical trials with medicinal products. All recommendations are aimed at: continue to ensure [...]

EMA Guidelines for COVID-19 Impact on Clinical Trial Methodology

2024-02-02T11:39:10+00:00March 26th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , , |

The European Medicines Agency (EMA) published a new draft guideline for clinical trials inviting sponsors to evaluate the implications of COVID-19 on methodological aspects of ongoing trials. This guidance covers actions that sponsors of ongoing clinical trials affected by [...]

Italy. Covid-19 infection reaches 59.138 with 5.476 deaths. Slowing trends of new cases and deaths recorded today for the first time.

2024-02-26T15:59:57+00:00March 23rd, 2020|Categories: Covid-19, Europe, Western Europe|Tags: , , , , |

A slowdown of the rising trends in the number of Covid infections and deaths was recorded today by the Italian Civil Protection. Healthcare workers infected rise to 4,824 and now their testing is prioritized. The total lockdown in Italy [...]

Zhejiang University Handbook of COVID-19 Prevention and Treatment

2024-02-29T17:19:53+00:00March 23rd, 2020|Categories: Clinical Trial, Covid-19|Tags: , , |

The Jack Ma Foundation and Alibaba Foundation have convened a group of medical experts who have just returned from the frontlines of fighting the pandemic in China. With the support of the First Affiliated Hospital, Zhejiang University School of [...]

Trials made easy: health authorities simplify GCP rules during pandemic

2024-02-29T15:05:31+00:00March 21st, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , |

20+ guidelines published last week to RESCUE ongoing trials amid the emergency. All authorities in Europe, Israel, USA and globally allow facilitations for patient safety and continuity of medical research, helping hospitals and sponsors. Immediate measures are needed to [...]

European Commission, EMA and HTA issue harmonized guidance for clinical trials during the COVID-19 pandemic

2024-02-07T15:54:29+00:00March 20th, 2020|Categories: Clinical Trial, Covid-19, Europe|Tags: , , , |

This guidance includes a harmonised set of recommendations, to ensure the utmost safety of trial participants across the European Union while preserving the quality of the data generated by the trials. It also advises how these changes should be [...]

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 [...]

FDA GUIDELINE FOR CLINICAL TRIALS OF MEDICAL PRODUCTS DURING PANDEMIC

2024-02-07T16:14:45+00:00March 18th, 2020|Categories: Covid-19, USA|Tags: , , , |

As the COVID-19 emergency impacts all healthcare sectors, the FDA issues guidelines to help industry and researchers. Safeguard of patients’ safety is the key concern, but also avoiding the compromised integrity of important studies due to missing data and [...]

MEDITRIAL HELPLINE SUPPORTS CLINICAL TRIALS DURING COVID-19 EMERGENCY

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 [...]

Israel Ministry of Health facilitates clinical trials and allows study products delivery to patient homes during the coronavirus outbreak

2024-02-26T12:22:48+00:00March 16th, 2020|Categories: Covid-19, Israel|Tags: , , , |

Following the outbreak of the COVID-19, the Israeli government issued new guidelines to faciliate clinical research. Meditrial has translated the guidelines issues by the Medical Technologies and Infrastructure Administration for Sponsors, Investigators, Helsinki Committees and Hospital Directors. These guidelines [...]

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