GERMANY: BfArM provides support for ongoing clinical trials

2024-02-26T11:10:55+00:00March 18th, 2020|Categories: Europe, Western Europe|Tags: , , , , , |

Germany reacts to the pandemic with high attention to ongoing clinical trials. According to the government authority BfArM, protocol deviations and changes may occur with the dynamic risk situation and restrictions due to Coronavirus SARS-CoV-2. A dedicated email, CT-COVID@bfarm.de, [...]

ESTONIA: Regulatory clarification for all concerned parties in clinical trials

2024-02-02T11:56:18+00:00March 18th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

The State Agency of Medicines issued a guideline on clinical trial management which is in effect until the end of the Emergency Situation, which was declared by the Government of Estonia until 1 May 2020. Meditrial manages several studies [...]

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 [...]

LATVIA: SAM recommendations to ensure continuity of clinical trials during pandemic

2024-02-26T16:07:57+00:00March 17th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

State Agency of Medicines (SAM) of Republic of Latvia issued guidelines on clinical research under COVID-19. Meditrial manages several studies in Latvia and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for [...]

PORTUGAL: Ethics Committee (CEIC) guidance on how to act towards COVID-19 in clinical trials

2024-02-29T14:03:18+00:00March 17th, 2020|Categories: Europe, Western Europe|Tags: , , , , |

Although the Ministry of Health (INFARMED) did not provide any guidelines so far, we understand that CEIC guidelines have been developed with the INFARMED team. Meditrial has direct connections with Investigators, hospitals and Portuguese Ethics Committees. Please feel free to [...]

Czech Republic Authority SÚKL issues clinical trial instructions for subject safety and data validity during COVID-19 emergency

2024-02-02T10:16:28+00:00March 16th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , , |

The Czech Authority  State Institute for Drug Control (SÚKL) has issued an opinion on a clinical research under current COVID-19 pandemic on 13 March and provided additional clarifications regarding the management of patients visits and study products on 16 [...]

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 [...]

MEDITRIAL OPENS OFFICES IN NEW YORK CITY

2024-02-29T13:43:37+00:00March 16th, 2020|Categories: Clinical Trial, Covid-19, Innovation|Tags: , , , |

Meditrial, best-in-class CRO for medical devices, launches new office in the heart of Manhattan. The New York city office is a brand new space to bring together people who share a dedication to innovation. Come visit the Training Center [...]

SLOVENIA: JAZMP operates smoothly under the current emergency

2024-02-29T14:12:25+00:00March 13th, 2020|Categories: Eastern Europe, Europe|Tags: , , , , |

Public Agency of the Republic of Slovenia for Medicines and Medical Devices (JAZMP) has issued a business notification to inform all interested stakeholders and the public that JAZMP’s operations are running smoothly for the time being. Moreover, JAZMP is [...]

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