Ash Mahmud’s Post

Are you ready for the upcoming ICH-GCP E6(R3) update? This revision builds upon the risk-based approach introduced in 2016, adapting to new trial designs and technological advancements. Our article explores what this update means for trial conduct and participant safety, offering insights into how these changes will influence future practices in clinical research. Learn more about the impact of ICH-GCP E6(R3) and read the full article here: https://hubs.li/Q02GxM6t0 #GCPCentral #ThereIsABetterWay

IRT is a dish best served simple! It can be so tempting to overload your IRT system with data collection and rules, hoping they will ensure perfect trial execution. But too often, study teams can end up tying themselves in knots when real life unfolds during a trial, and a patient or site need to flex a bit. Read more in the IRT Insights newsletter edition "IRT: 3 Principles Clinical Operations Teams need to follow" - https://lnkd.in/eMsrsR42 #clinicaltrials #clinicaltrial #clinicalresearch #IRTInsights #IRT

EDC - Feature of the week #28 ✅ How Can Sponsor Oversight Be Made More #Efficient? ✅ We asked ourselves the same question - and we’ve found the answer! In our #EDC, clear visual #insights into study #data are guaranteed through on-the-spot 📊figures, 📈graphs, 📄and reports, tailored to each study’s #KRIs and #QTLs. Additionally, our PD Tracker gives sponsors real-time access to all documented Protocol Deviations, alerting them to major issues. Sponsors can easily comment on or assess deviations directly in the eCRF - a feature highly appreciated by regulators! With real-time insights, visualisations and the PD Tracker, we lay the foundation for perfect sponsor oversight! 🌟 #ClinicalTrials #ClinicalResearch

There’s exactly 2 weeks to go until IRT 2024 unites the interactive response technologies and clinical supply community, uniquely special in your dedication to maximizing supply chain efficiency, optimizing operations and accelerating therapeutic development! Will you be there? It won't be the same without you! 👉 Register now: https://lnkd.in/e73pnYGj 📑 Download the agenda to learn more: https://lnkd.in/erzAtAh6 #IRT2024 #IRT #InteractiveResponseTechnologies #ClinicalSystems #ClinicalSupply #ClinicalOperations #ClinicalTrials #ClinicalData #ClinicalResearch #RTSM #ClinicalTechnology #PatientExperience

We're live at #TCT2024. Interested in exchanging some thoughts about your clinical strategy, regulatory pathway or how to structure your clinical trials for efficiency? Send Christof a text at +32 474 34 53 01 and meet him at the conference. #TCT2024 #medicaldevices #expectexcellence

107th Meeting of the DSK According to the press release on the upcoming 107th meeting of the Conference of Independent Data Protection Authorities of the Federal and Länder (#DSK) on May 14 and 15, 2024 in #Bremerhaven, the DSK will focus on, among other things, #regulatory gaps in the handling of #patient #data when #hospitals close and the processing of personal data for scientific #research purposes. The #MedTech industry is already eagerly awaiting the results! 🤟 And personally, I hope that Mr. Kelber's work in the past 4.5 years will be adequately appreciated, as this will probably be his last participation. #LEP #LinkedInNewsDACH https://lnkd.in/eKXdhi6S

Inefficient #EDC systems could account up to 30% of errors in your trial data and can increase the costs by 25%! But our InductiveEDC can help you achieve considerable and consistent results, just like how it powered multiple studies across the world. Built robustly, IEDC breaks you free from the hassles of paper-based #datacapturing processes and strengthens your data management environment seamlessly. Know how you can achieve significant success in your clinical trials with IEDC here: https://bit.ly/4cefJEe #ClinicalTrials #LifeSciences #ClinicalResearch 

SOCRA is excited to offer this new comprehensive two day in-person workshop where you'll gain a solid understanding of the fundamental considerations for Decentralized Clinical Trials (DCTs) and learn practical approaches to designing, administration, and implementation. Read the Blog Highlighting this New Program >> https://lnkd.in/eUv5qpX2 Learn More >> https://smpl.is/8sbof Browse the Agenda >> https://smpl.is/8sbog Register >> https://smpl.is/8sboh #SOCRA #clinicalresearcheducation #decentralizedclinicaltrials

SAVE THE DATE: Vulcan Utilizing the Digital Protocol webinar - an HL7 Vulcan project WHEN: 11 July 2024 09.00 - 10.30 am Eastern Time PANELIST: Hugh Glover, Mary Lynn Mercado, John Owen The agenda for this webinar is now available, key topics are: • Outline the goals of the UDP project, • Deliver a summary of the first UDP Connectathon • Describe the intent and potential impact of M11 from an ICH M11 speaker • Announce the upcoming UDP Connectathon in September • Facilitate a Q&A session, #HL7Vulcan, #hl7, #FHIR, #CDISC, #ICH, #CeSHARP, #TransCelerate WHO can attend: anyone interested in Clinical Data Interoperability, Sponsor and CROs involved in processes that consume protocol information, Health authorities, Please for more information and registration follow the link below https://lnkd.in/e3DH68xU

🌐📚 Never stop learning!   Take your seat at #clicglobal2024: 8 live cases with real-time procedures, comprehensive case-based lectures about the latest techniques, and debates with international experts await you. 🚀   View the program: https://lnkd.in/duQmvdBs   • • • #CLTI #SavingLimbs #medical #criticallimbischemia #medicine