European Medicines Agency’s Post

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

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

In fully decentralized clinical trials, all activities take place at locations other than traditional trial sites. These trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants. In hybrid DCTs, some trial activities involve in-person visits by trial participants to traditional clinical trial sites, and other activities are conducted at locations other than traditional clinical trial sites, such as participants’ homes.  Source: FDA DCT draft guide. #clinicalresearchassociate #clinicaltrials #fda #fdaregulations #dct #oncologytrials

Time for some Q&A! A detailed and a well-written protocol is key to success of any clinical trial. Need expert guidance? Want to ease through clinical trial management? We got you covered. Follow link to access our clinical trial services: https://lnkd.in/gUiVdmw6 #foodresearchlab #clinicaltrials #clinicaltrialmanagement #evidencebasedmarketing

⏰ Time is running out for EU Clinical Trial Regulation 536/2014 (EU-CTR) compliance! Sponsors now have less than nine months to transition or face termination in all 30 EEA countries ❌ Thousands of clinical trials have yet to start the process, which can take 60 days or more for a slim dossier submission, timelines we could see stretching even longer as demand ramps up. In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Esther Gil, Celina González-Colaço, and Claire Browne share guidance for navigating this complex and consequential process, including actionable recommendations for timely compliance. Learn more in the article below and subscribe for the latest #NovelInsights from our bi-weekly clinical trial newsletter!

⏰ Time is running out for EU Clinical Trial Regulation 536/2014 (EU-CTR) compliance! Sponsors now have less than nine months to transition or face termination in all 30 EEA countries ❌ Thousands of clinical trials have yet to start the process, which can take 60 days or more for a slim dossier submission, timelines we could see stretching even longer as demand ramps up. In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Esther Gil, Celina González-Colaço, and Claire Browne share guidance for navigating this complex and consequential process, including actionable recommendations for timely compliance. Learn more in the article below and subscribe for the latest #NovelInsights from our bi-weekly clinical trial newsletter!

⏰ Time is running out for EU Clinical Trial Regulation 536/2014 (EU-CTR) compliance! Sponsors now have less than nine months to transition or face termination in all 30 EEA countries ❌ Thousands of clinical trials have yet to start the process, which can take 60 days or more for a slim dossier submission, timelines we could see stretching even longer as demand ramps up. In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Esther Gil, Celina González-Colaço, and Claire Browne share guidance for navigating this complex and consequential process, including actionable recommendations for timely compliance. Learn more in the article below and subscribe for the latest #NovelInsights from our bi-weekly clinical trial newsletter!

⏰ Time is running out for EU Clinical Trial Regulation 536/2014 (EU-CTR) compliance! Sponsors now have less than nine months to transition or face termination in all 30 EEA countries ❌ Thousands of clinical trials have yet to start the process, which can take 60 days or more for a slim dossier submission, timelines we could see stretching even longer as demand ramps up. In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Esther Gil, Celina González-Colaço, and Claire Browne share guidance for navigating this complex and consequential process, including actionable recommendations for timely compliance. Learn more in the article below and subscribe for the latest #NovelInsights from our bi-weekly clinical trial newsletter!

⏰ Time is running out for EU Clinical Trial Regulation 536/2014 (EU-CTR) compliance! Sponsors now have less than nine months to transition or face termination in all 30 EEA countries ❌ Thousands of clinical trials have yet to start the process, which can take 60 days or more for a slim dossier submission, timelines we could see stretching even longer as demand ramps up. In this edition of the New Medicines, Novel Insights newsletter, Parexel’s Esther Gil, Celina González-Colaço, and Claire Browne share guidance for navigating this complex and consequential process, including actionable recommendations for timely compliance. Learn more in the article below and subscribe for the latest #NovelInsights from our bi-weekly clinical trial newsletter!