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 [...]

FRANCE: ANSM offers practical solution to manage clinical trials amid the crisis

2024-02-26T11:01:22+00:00March 20th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

The ANSM, in conjunction with the DGS and the DGOS, offers practical solutions for implementing the necessary adaptations for clinical trials in progress in the current situation. The solutions proposed by the authorities have been established in order to [...]

POLAND: Authorities suspend inspection of clinical trials till the end of April 2020 due to COVID-19

2024-02-29T14:01:20+00:00March 19th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland issued guidelines on clinical research under COVID-19. Inspections activity of clinical trial is suspended until the end of April 2020. The decision to resume the [...]

NETHERLANDS: Central Research Committee announces approval fastrack for trials to develop COVID 19 vaccines

2024-02-29T13:55:20+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

The Netherlands’ Central Committee on Research Involving Human Subjects (CCMO) announced the availability of fast-track approval procedures for clinical trials related to the development of vaccines for COVID-19. To make use of this procedure, please contact CCMO via ccmo@ccmo.nl or telephone [...]

GREECE: EOM changes opening hours during COVID-19 emergency

2024-02-26T11:19:29+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

The Department of the General Secretariat of the National Organization for Medicines (EOM) announced the adoption of preventive measures and under the protection of public health against the coronavirus will operate from 10:00 to 14:00 during working days for the [...]

SLOVAKIA: SUKL issues guidance on patients´ risk assessment during COVID-19 emergency

2024-02-29T14:11:03+00:00March 19th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

The State Institute for Drug Control (SUKL) recommends some specific measures for the COVID-19 emergency. Meditrial manages several studies in Slovakia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice [...]

NORWAY: NoMA allows changes and safety measures in clinical research prior to approval during COVID-19 emergency

2024-02-29T13:58:34+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

Norwegian Medicine Agency (NoMA) guided many aspects of clinical research in response to COVID-19 emergency. Meditrial manages several studies in Norway and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice [...]

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 [...]

ITALY activates safeguard procedures for clinical trials during pandemic

2024-02-26T12:32:21+00:00March 19th, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

The Italian Medicines Agency provides indications regarding the management of clinical trials in Italy during the COVID-19 (coronavirus disease 19) emergency. The guidelines describe the measures to manage clinical trials during the emergency and the exemptions granted. Download in [...]

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