TrialAssure’s Post

📢 📢Exciting news for the EU Clinical Trials Information System (CTIS)! ✨ The EMA has adopted revised transparency rules, removing deferral mechanisms to provide faster access to clinical trial data. Patients, healthcare pros, and sponsors all benefit, striking a balance between transparency and confidentiality. #CTAsubmissions #ClinicalTrialApplication #EUCTR #CTIS https://lnkd.in/gs4PkF5t

Revised transparency rules for the EU Clinical Trials Information System (CTIS) News 06/10/2023 EMA has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System. The simplifications introduced will give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way. #clinicaltrialtransaparency, #CTIS, #EUCTR, #Clinicaltrialdisclosure

The revised transparency rules for the Clinical Trials Information System (CTIS) will become applicable on 18 June 2024, with the launch of a new version of the CTIS public portal. The updated rules strike a balance between transparency of information and protection of Commercially Confidential Information (CCI). They benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early. They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data. Sponsors are advised to adapt their business processes accordingly, and can refer to the quick guide for users for an overview of the changes: https://lnkd.in/dtjEgbmB ACT EU news item: https://lnkd.in/dQAhP8VF #clinicaltrials #transparency #CTIS

The European Medicines Agency has adopted revised rules to enhance the publication of clinical trial information through the Clinical Trials Information System. These changes streamline access for stakeholders, including patients and healthcare professionals, making it faster and more efficient. Key points: - Removal of the deferral mechanism, allowing earlier publication of critical trial data. - Striking a balance between transparency and protecting confidential information. - Simplifying processes for clinical trial sponsors. - Creating a more user-friendly system for healthcare professionals and patients. #clinicaltrials #drugdevelopment #research #EMA #healthcare https://lnkd.in/e8uEhqpY

The European Medicines Agency (EMA) has updated the CTIS transparency rules, significantly improving access to clinical trial information. These changes, including the removal of data publication deferrals, strike a balance between open access and data protection, benefiting patients and healthcare professionals alike. Learn more about the updated rules here: https://loom.ly/qnMMt4s #ClinicalTrials #EMA #CTIS

On 18 June 2024, the European Medicines Agency (EMA) implemented revised transparency rules for the Clinical Trials Information System (CTIS) alongside a new version of the CTIS public portal. These changes enhance the accessibility and clarity of clinical trial data, supporting informed decision-making for patients, healthcare professionals, and researchers. Key improvements include better search functionalities, user-friendly interfaces, and more detailed trial summaries. This initiative reflects the EMA's commitment to transparency and public health protection. All trials submitted on or after 18 June 2024 will follow the principles and timelines defined in the revised rules. (https://lnkd.in/eWx7kAS5) There will be an EMA live broadcast about these changes tomorrow, June 20, which will provide an opportunity for sponsors to familiarize themselves with the revised transparency rules, accessible via the EMA’s website (www.ema.europa.eu). If you have any questions or feel lost navigating these changes, the team at QRCC is here to help guide you. Please feel free to reach out to us via InMail or via the contact form on our website, here: https://lnkd.in/ekeJhhdQ #CTIS #ClinicalTrialData #EMARegulations #TransparencyInResearch

As of 18 June, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency apply, and will impact patients, health care professionals and sponsors. The revised rules aim to simplify the submission of data and documents, but also include several changes that could impact the treatment of commercially confidential information and protection of patient data. #clinicaltrials #EU

As of 18 June, the Revised CTIS Transparency Rules as adopted by the European Medicines Agency apply, and will impact patients, health care professionals and sponsors. The revised rules aim to simplify the submission of data and documents, but also include several changes that could impact the treatment of commercially confidential information and protection of patient data. #clinicaltrials #EU

Discover how the EMA's revamped transparency rules for clinical trials are set to reshape access to vital information, benefiting patients, healthcare professionals, and sponsors alike. #medicalaffairs #medicinesdevelopment #EMA #clinicaltrials #CTIS

Title: Cutting-edge Update: CTIS Transparency Rules Revolutionized! Published By: European Medicines Agency; Date - 22 April 2024. Background: The European Medicines Agency unveils revamped CTIS transparency regulations, enhancing data accessibility while safeguarding sensitive information. Learnings: > Revised rules prioritize patient interests, promptly publishing pertinent trial details flagged by patients. > Elimination of the deferral mechanism accelerates data disclosure, benefiting sponsors and enhancing transparency. > New CTIS public portal version, effective June 18, 2024, expands trial data accessibility, amplifying public resource availability. > Sponsors can already adopt revised transparency principles pre-June 18, 2024, facilitating seamless adaptation. More information: https://lnkd.in/gxrGs_kg #clinicaltrials #regulatorycompliance #pharmainnovation #pharmout PharmOut https://lnkd.in/gUaieqq6