News about clinical trials

  • Call for interest launched for COMBINE pilot exploring the feasibility of coordinated assessment across EU Member States for combined studies

    | 16 June 2025 |

    Call for interest for COMBINE pilot is now launched in COMBINE project 1 and the sponsors of combined studies are encouraged to express their interest to participate. A webinar for interested sponsors will be hosted 20 June 2025, 2-4pm CEST. Please find details on the webinar, eligibility criteria and pilot process on the European Commission COMBINE Project 1 dedicated subpage: COMBINE Project 1 – pilot “all-in-one” coordinated assessment - European Commission.

  • Remember to Enter Start Dates in CTIS

    | 19 February 2025 |

    This is a technical necessity to ensure that the trial, and thus the approval, does not expire.

  • New Protocol Template for Clinical Trials

    | 06 February 2025 |

    We have updated our protocol template to include even more guidance from both the Danish Research Ethics Committees and the Danish Medicines Agency. By starting out from this improved protocol template it can to a higher degree be assured that the regulatory demands to the protocol are met – and hopefully the process of developing the protocol is made easier and better. ​