Clinical Research Community

Dear DIA Colleagues, The third revision of the ICH E6 - GCP was released by the ICH on 06 Jan 2025 and you can download it here Link . I expect the ...

Hi all, The latest CTIS Newsflash was published today (14 Jan 2025). Please see below some reminders and updates published as part of this release: ...

Dear DIA Colleagues, Blessed year 2025! Kamila ------------------------------ Kamila Novak, MSc Auditor, Consultant KAN Consulting Athens, Greece ...

Dear DIA Colleagues, Warm holiday wishes whichever you celebrate. Kind regards, Kamila ------------------------------ Kamila Novak, ...

Hi all, The Indonesia Clinical Research Registry (INA-CRR) has announced that they will be transitioning to a new website for clinical research registry ...

Hi all, The EMA and HMA (Heads of Medicines Agencies) have published their updated guidance for identification of commercially confidential information ...

Thank you, Kamila! Hope you're having a great week! Best, Sanjay ------------------------------ Sanjay Bagani Xogene Services LLC United States sanjay@xogene.com ...

Hi all, Please see below some key highlights from latest EU CTIS Newsflash: Spotlight: 10,000 trials submitted in CTIS: Over ten thousand clinical ...

Dear all, A workgroup established by industry experts in collaboration with CISCRP (a not for profit organization), which I am a part of has drafted ...

Hi Sanjay, Many thanks for all the regulatory and disclosure updates! Have a great week. Kamila ------------------------------ Kamila Novak, MSc ...

Hi all, EMA has published a new version of CTIS Training Module- 10 " FAQs: How to create, submit and withdraw a Clinical Trial Application ". As per ...

Hi all, EMA has published the highlights from EMA Management Board: December 2024 meeting. Please see below the information published related to EMA ...

Hi all, On Dec 13, 2024, EMA has announced a new Clinical Trials Information System (CTIS): Walk-in clinic to be held on Wednesday, 29 January 2025, ...

Hi all, On Dec 13, 2024, the updated version of " Revised CTIS transparency rules & historical trials: quick guide for users " was published. The document ...

Hi all, EMA has published the updated version of following documents and the structured data form for Initial application, additional Member State Concerned, ...