Recruiting and training clinical trial staff is a costly and time-consuming process. MCRA has a ready pool of sites and experts, saving you the expenses associated with recruitment and onboarding. MCRA’s contracting team has worked with hundreds of sites and institutions across the globe. We leverage our extensive experience and relationships to streamline the process of implementing clinical trials for our clients — saving them significant time and money. #MCRA #CRO #ClinicalResearch #MedicalTechnology #MedicalDevice #ClinicalResearch #Regulatory #Reimbursement #compliance #SpecializedTherapyExpertise Learn how to optimize your trials with advice from global clinical research experts! Contact us https://lnkd.in/ehwSCmAm
MCRA, an IQVIA business’ Post
More Relevant Posts
-
Why is Regulatory understanding crucial for business development personnel? Working in the clinical research field with a thorough understanding of clinical trials and the regulatory pathway for each entity helps a lot in our field. Earning Client Trust: Clients expect CROs to be well-versed in regulation, fostering trust in the CROs ability to conduct trials ethically and legally Creating Realistic Plans: Knowing the regulatory landscape well, enables us to prepare accurate project plans and proposals. Adaptability: Keeping up with the evolving regulatory helps us in adapt quickly and stay compliant. Staying Ahead: Knowing the rules inside out gives us an edge over competitors and shows clients we're serious about quality and compliance. Comment your thoughts 💭 on this!!!! #businessdevelopment #clinicalresearch #CRO #Regulatoryaffairs #USFDA #EMA #CDSCO
To view or add a comment, sign in
-
Arex can help you to transition your clinical trial from CTD to CTR within time...
Will your clinical trial continue after 30 January 2025? The EMA reminds all sponsors to transfer from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Sponsors are advised to take into account that the Member State(s) evaluation procedure can take up to 3 months. How does this affect you? Speak to one of our experts! contact@arexadvisor.com #arexadvisor #regulatoryaffairs #cmc #qualityassurance #Drugdevelopment #EMA #CTIS #CTR #clinicaltrial
To view or add a comment, sign in
-
Will your clinical trial continue after 30 January 2025? The EMA reminds all sponsors to transfer from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Sponsors are advised to take into account that the Member State(s) evaluation procedure can take up to 3 months. How does this affect you? Speak to one of our experts! contact@arexadvisor.com #arexadvisor #regulatoryaffairs #cmc #qualityassurance #Drugdevelopment #EMA #CTIS #CTR #clinicaltrial
To view or add a comment, sign in
-
Great resource for regulatory questions on clinical research! Use my promo code for a discount. https://bit.ly/492SIlS #GCP #Scopesummit #goodclinicalpractice #Regulatoryaffairs #FDA #regulatorycompliance #IND #clinicalresearch #clinicaltrials
To view or add a comment, sign in
-
-
Numerous US sponsors strategically defer engaging with the FDA until preliminary safety data is gathered through early first-in-human trials in Canada via the Clinical Trial Application (CTA). This approach expedites the clinical development timeline, streamlines the IND approval process, and fosters dialogue with investors and the FDA to discuss forthcoming milestones, particularly Phase II. Please let me know if you want to learn how our strategy can benefit your organization by saving time and cost while expediting your product approval process. @nlidiraa@biopharmaservises.com #FDA #ClinicalTrials #INDApproval #ClinicalDevelopment #CTA #FIH
To view or add a comment, sign in
-
FDA published a draft guidance, "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies": https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #regulatoryscience #regulation #regulatorysubmission #clinicalstudy #drugs #regulatoryupdate
To view or add a comment, sign in
-
Article | The New ICH E6 (R3) Guidelines: Impact on Clinical Trials Our new Article written with our GCP Auditor and QMS Specialist Laura Wilson is available on our website now. In anticipation of the new ICH GCP E6(R3) guidelines, which are due to be implemented in August / September 2024, as Arithmos we would like to discuss the evolution of clinical trial designs and proportional risks⏩ https://zurl.co/Yxto As the Life Sciences industry embraces increasingly complex clinical trials to develop innovative therapies, ensuring patient safety and regulatory compliance remains paramount. To address these evolving needs, the International Council for Harmonisation (ICH) is introducing a revision to its E6 Guideline for Good Clinical Practice (GCP). Read the full article through the link above👀 #clinical #clinicaltrials #lifescience #pharma #clinicalregulations #ICH #digitaltransformation #GCP #clinicalpratice
To view or add a comment, sign in
-
-
The FDA is focusing on advancing diversity in clinical trials. With recently released draft guidance, it can be hard to keep up. Don’t worry – we have you covered. Find all the important details in our blog: https://bit.ly/3LlzJcC #ClinicalTrialDiversity #FDAGuidance #FDA #HealthcareDiversity #ClinicalTrials #ClinicalDevelopment
To view or add a comment, sign in
-
-
📌 WEBINAR | Clinical Trials transition to CTR/CTIS 💻 Ready to equip yourself with first-hand information from our experts? Join us in our new #FreeWebinar, “Clinical Trials transition to CTR/CTIS”. 🌐 All ongoing #clinicaltrials in the EU must be transitioned to #CTIS if they are expected to continue beyond 30 January 2025. 📅 To help streamline the process, Member States will implement, where possible and up to 16 October 2024, an expedited procedure for transitioning trials to the #CTR. ↪️ Since we are approaching the second half of the final year of transition, it is crucial for sponsors to plan and submit the transition application #asap to ensure a timely approval and to prevent the potential cessation of trials that do not conform to the new regulation. ↪️ Join ASPHALION expert Nuria García Pazos, Regulatory Affairs Senior Consultant, as she goes over: · Transition timelines and procedures · How to prepare a transition application · Management of Post-transition actions 🔗 Register here: https://bit.ly/4aztOLV 📧 For further information you can contact us at: info@asphalion.com https://bit.ly/3JpRqGN #FreeWebinar #Webinar #CTIS #CTR #ClinicalTrials #EU #Timelines #Procedures #Application #Regulatory #MeetTheExpert #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience
To view or add a comment, sign in
-
Freelance Consultant Clinical Trial Regulatory Affairs & Study Start-Up, CTR/CTIS Sponsor Master Trainer, Founder, Speaker and your Rock in the surf
🚨 Important Update for Sponsors: New Resource for CTR 536/2014 Transition 🚨 As a Regulatory Affairs & Study Start-up consultant, I stay up-to-date on the latest developments impacting clinical trials. Recently, the European Commission published a new resource to assist sponsors with transitioning ongoing clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR) 536/2014. Key Point: 📚 New Resource: The European Commission published on EudraLex Vol. 10 the "Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation" to aid sponsors in the CTR transition process. You can access the guidance here: https://lnkd.in/e6AEgF5K What this means for Sponsors: ⏰ Deadline Approaching: It's crucial to remember that only the CTR and its delegated acts will be applicable from January 31, 2025. This means sponsors of ongoing clinical trials under the CTD need to transition their trials to the CTR by this deadline to remain compliant. 🚀 Action Required: Sponsors should review the new guidance to understand their obligations and the steps involved in transitioning their trials. 🔍 Seek Expert Advice: Given the complexity of the transition process, consulting with a qualified regulatory affairs professional is highly recommended. Feel free to connect with me to discuss your specific needs and explore how I can assist you in navigating the CTR transition process. #RegulatoryRocks #CTISrocks #TransitionalTrials #CTIS #CTR #ClinicalTrials #SSU #regulatory #regaffairs #RegulatoryAffairs #StudyStartUp
10c83e6b-2587-420d-9204-d49c2f75f476_en
health.ec.europa.eu
To view or add a comment, sign in
Felix Perez, CEO Research Director
1moStreamlining clinical trial operations is crucial for efficiency and success. MCRA's approach to leveraging their extensive site network and expertise promises significant savings in time and costs for clinical trial implementation.