Emer Cooke’s Post

🕵♀️ Did you know that a lot more information on ongoing clinical trials has been made publicly available in CTIS? With the change to the transparency rules, applicable as of Tuesday June 18th, you can now find information about many ongoing clinical trials that were previously deferred, such as: 🔵 Protocol and patient facing documents 🔵 Details on study design, as endpoints, objectives, and in- and exclusion criteria 🔵 Active sites and their contact information   If you have an ongoing clinical trial, make sure to check no confidential information has been published through the portal!

Important information and do reach out if you need support with the transition, it is a core competency of tranScrip.

A very important reminder for all those involved in clinical research ! 🔬 The transition from the CT Ditective to the Clinical Trials Regulation is instrumental to enhance the safety of subjects involved in clinical trials and facilitate multi national clinical trials across EU . Thanks in advance for proceeding with your applications through CTIS ⏱️💻🗂️👩🏻🔬👨🏽🔬 #clinicaltrials #clinicalresearch

I hope this announcement finds you well. Any clinical trials conducted in the European Union(EU) must be transitioned to the Clinical Trials Information System(CTIS) by 30 January 2025. EMA has mandated that all clinical trials expected to continue beyond 30 January 2025 must transition to the Clinical Trial Information System, marking a significant step towards improved transparency and efficiency in clinical research. More attentive information can be found at the following address. https://lnkd.in/gYqtJpbS . or link to the following announcement. #clinicaltrial #CNRResearch #EMA #CTIS

So far, a total of 1,243 clinical trials have been transferred to the #CTIS! Last week ANSM, the French Competent Authority send out CTIS transition forms to be completed by the sponsors. It's a good step to ensure all CTIS transferred studies are approved before the deadline, especially considering that the summer holiday period is not too far away. Also last Monday, EMA released a CTIS newsflash in which the Sponsors are reminder to transition any trials that are expected to continue after 30 January 2025 from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Sponsors should take into account the time necessary for completion of the Member State(s) evaluation procedure, which can take up to 3 months. When possible, Members States have agreed on an expedited procedure for transitioning trials to the CTR. Some interesting CTIS facts: - So far, a total of 1,243 clinical trials have been transferred to the CTIS (data from 15th April) - the number of the applications in the week of 15th April increased by 20% comparing to the week before. - Competent Authorities with a highest number of CTA/CTIS transition decisions issued in the week of 15th April were Denmark and Spain AnRes Clinical team has experience with transferring trials into the CTIS, so for any questions related to the process, please do not hesitate to get in touch with us. #CTIS #clinicaltrials #ClinicalTrialRegulation #AnResClinical

So far, a total of 1,243 clinical trials have been transferred to the #CTIS! Last week ANSM, the French Competent Authority send out CTIS transition forms to be completed by the sponsors. It's a good step to ensure all CTIS transferred studies are approved before the deadline, especially considering that the summer holiday period is not too far away. Also last Monday, EMA released a CTIS newsflash in which the Sponsors are reminder to transition any trials that are expected to continue after 30 January 2025 from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Sponsors should take into account the time necessary for completion of the Member State(s) evaluation procedure, which can take up to 3 months. When possible, Members States have agreed on an expedited procedure for transitioning trials to the CTR. Some interesting CTIS facts: - So far, a total of 1,243 clinical trials have been transferred to the CTIS (data from 15th April) - the number of the applications in the week of 15th April increased by 20% comparing to the week before. - Competent Authorities with a highest number of CTA/CTIS transition decisions issued in the week of 15th April were Denmark and Spain AnRes Clinical team has experience with transferring trials into the CTIS, so for any questions related to the process, please do not hesitate to get in touch with us. hashtag #CTIS hashtag #clinicaltrials hashtag #ClinicalTrialRegulation hashtag #AnResClinical

What is a Feasibility Questionnaire (FQ)? Imagine this. A Sponsor is getting ready to launch a new study. The Sponsor or CRO creates a Feasibility Questionnaire, which is a set of questions to help identify sites and Investigators that are best equipped to run a successful clinical trial. Sites and Investigators who are interested in participating in the clinical trial complete the FQ. It typically includes the Investigator’s information, Institution’s information, and questions such as: - Type of site - How the site will recruit patients - Number of clinical trials conducted at the site - Approximate number of patients they think they can enroll - Central or Local IRB - And more Feasibility Questionnaires can be detailed to enable the Sponsor and CRO to select the most qualified sites to move to the next stage which is a Pre-Study Visit. What questions do you have about FQs?

On International Clinical Trials Day, we want to remind sponsors that they need to act now to ensure the transition of your clinical trial to the Clinical Trial Regulation. Any clinical trial expected to be running beyond 30 January 2025 must be transitioned to the Clinical Trial Information System (#CTIS) to follow the new regulation. Start planning now! The time required to complete the authorisation can take up to three months. Watch the video ⬇ and visit 🔗 https://lnkd.in/dnUqAsp7 for more information. #ClinicalTrial

🔬How can sites secure more studies as competition gets fiercer? Explore the key strategies for maintaining a steady study pipeline in a highly competitive environment in our blog, "How to Attract Sponsors & CROs: 3 Lessons from Top Clinical Trial Sites." Discover how to fortify your site's position and secure more studies with these essential tactics: ✅ 𝐇𝐢𝐠𝐡 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐄𝐧𝐫𝐨𝐥𝐥𝐦𝐞𝐧𝐭: the pivotal role of patient recruitment in enhancing site performance and attracting study opportunities. ✅ 𝐂𝐥𝐞𝐚𝐧 𝐃𝐚𝐭𝐚: Explore the importance of maintaining clean and trackable data to showcase your site's research efficacy and reliability. ✅ 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞𝐝 𝐏𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬: Learn how standardized, streamlined processes can optimize your site's efficiency and bolster its overall quality. Enhancing these core aspects will not only elevate your site's consistency and quality but also build a strong reputation, drawing the attention of prominent sponsors and CROs. Discover how you can implement these strategies and elevate your clinical site's performance right here: https://lnkd.in/g4kSzVhC #ClinicalTrials #ClinicalResearch #BetterData #Compliance #FDACompliance

🔬How can sites secure more studies as competition gets fiercer? Explore the key strategies for maintaining a steady study pipeline in a highly competitive environment in our blog, "How to Attract Sponsors & CROs: 3 Lessons from Top Clinical Trial Sites." Discover how to fortify your site's position and secure more studies with these essential tactics: ✅ 𝐇𝐢𝐠𝐡 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐄𝐧𝐫𝐨𝐥𝐥𝐦𝐞𝐧𝐭: the pivotal role of patient recruitment in enhancing site performance and attracting study opportunities. ✅ 𝐂𝐥𝐞𝐚𝐧 𝐃𝐚𝐭𝐚: Explore the importance of maintaining clean and trackable data to showcase your site's research efficacy and reliability. ✅ 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞𝐝 𝐏𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬: Learn how standardized, streamlined processes can optimize your site's efficiency and bolster its overall quality. Enhancing these core aspects will not only elevate your site's consistency and quality but also build a strong reputation, drawing the attention of prominent sponsors and CROs. Discover how you can implement these strategies and elevate your clinical site's performance right here: https://lnkd.in/ddewqEt6 #ClinicalTrials #ClinicalResearch #BetterData #Compliance #FDACompliance