Just in Time GCP

Exciting News from Just in Time GCP! Subscribe here - https://lnkd.in/e9qXnSiB The first issue of The GCP Compass has landed! ?? This new resource is designed to help clinical research professionals navigate the evolving landscape of GCP compliance with confidence. Inside, you’ll find expert insights, key industry trends, and practical strategies to enhance compliance and operational efficiency. Didn't receive it in your inbox? Don’t miss out—sign up now to stay ahead in clinical excellence! ?? https://lnkd.in/e9qXnSiB #ClinicalTrials #GCPCompliance #ClinicalResearch #TheGCPCompass #JustInTimeGCP

? Will we see you in Geneva? We’re excited to be speaking at the CDISC + TMF Europe Interchange this May! Our team will be presenting on how to leverage next-generation tools to optimize TMF processing, enhance efficiency, and share insights from the CDISC TMF Reference Model V4 Project. Read more about our participation here - https://lnkd.in/exJjUxW6 ? Real-world solutions ? Expert perspectives ? Meaningful progress in clinical compliance Just in Time GCP is proud to be an Emerald Sponsor—and even prouder to be part of a community driving clinical excellence forward. ?? Planning to attend? Let’s connect. ?? Discounted registration runs through March 14! https://lnkd.in/gH9Cgk9A Aaron Grant Carol Radwanski Donna Dorozinsky Kathleen Mellet #CDISC #TMFInterchange #ClinicalCompliance #ClinicalTrials #TMF #GCP #InspectionReadiness #JustInTimeGCP

?? Is your clinical trial really protected? You wouldn’t drive without insurance—so why risk running a trial without proactive GCP compliance? Inspections can happen at any time—and if you’re not prepared, the consequences can be costly. Proactive GCP compliance isn’t just a regulatory checkbox—it’s your trial’s best insurance policy. ? But what does proactive compliance really look like in practice? ? What are the hidden risks most teams overlook? ? And how can you protect your trial before the damage is done? We break it all down in our latest article: https://lnkd.in/e2GBRPHX Learn how Just in Time GCP can help you stay ahead of risk before it becomes a problem - https://hubs.li/Q038GGjD0 #ClinicalCompliance #GCP #TMF #ClinicalTrials #InspectionReady #JustInTimeGCP

Clinical compliance isn’t just about checking boxes—it’s about confidence. At Just in Time GCP, we help clinical teams stay inspection-ready, streamline systems, and manage compliance with ease. With experience across 100+ regulatory inspections, we know what it takes to navigate the evolving GCP landscape. ?? Need a strategic partner to support your clinical compliance journey? Explore our tailored solutions today: https://hubs.li/Q038GGjD0 #GCP #ClinicalCompliance #ClinicalTrials #InspectionReadiness #RegulatoryAffairs #TMF #QualityAssurance

? True compliance support goes beyond the checklist—It's about partnership, trust, and shared success. At Just in Time GCP, we take pride in being more than just a service provider. We’re a partner, invested in the success of every clinical trial and partner we support. Hearing feedback like this reminds us why we do what we do. Thank you to our clients for trusting us to navigate compliance with confidence. Your success is our success! ?? Looking for a compliance partner who’s as invested in your success as you are? Let’s talk. https://hubs.li/Q038G_DT0 #GCP #ClinicalCompliance #ClientSuccess #ClinicalTrials #PartnershipMatters

Appreciate the partnership J.Schmid! Innovation isn’t just about compliance—it’s also about how we communicate it. Working with a team that understands our vision and helps us bring it to life has been invaluable. Excited for what’s ahead as we continue to evolve the Just in Time GCP brand together! #InnovationInGCP #ClinicalCompliance #BrandEvolution #ClinicalTrials #MarketingThatMatters #Partnerships

?? What does clinical compliance confidence look like? ?? It means being able to confidently answer “YES” to all the critical questions in the image below. ? If you're not there yet, Just in Time GCP can help. Our expertise ensures your clinical trials stay on track, your systems work for you, and you can sleep well at night with compliance confidence. Check out out our services page - https://hubs.li/Q038GKMt0 #GCP #ClinicalCompliance #ComplianceConfidence #ClinicalTrials #JustInTimeGCP

?? Tina Henderson, RN, MBA, MS, CCRA, CCRC: Driving Change in Life Sciences Consulting ?? With over 25 years in clinical research and life sciences, Tina Henderson, RN, MBA, MS, has navigated every corner of the industry—from ER trauma nursing to site leadership, pharma strategy, and business transformation. Now, as Head of Life Sciences Consulting at Just in Time GCP, she’s bringing her expertise in change management, process optimization, and clinical compliance to help organizations scale smarter and execute with impact. Read more about Tina's unique perspective here - https://lnkd.in/eaMvgrsE #ClinicalResearch #LifeSciences #Leadership #ClinicalCompliance #JustInTimeGCP

We are all working towards the same goal, getting patients the treatments they need. No one wants to delay their clinical trial due to a compliance issue that could have easily been avoided. Just in Time GCP wants to help, no strings attached, we just want to share our knowledge and experience from being a part of over 100 regulatory inspections. So ask away! Submit your questions here - https://lnkd.in/ehnQPX2M #clinicalresearch #clinicalcompliance #gcpcompliance #JITGCP #clinicaloperations

?? ICH E6(R3) is here – Are you ready for Risk-Based Quality Management (RBQM)? ?? With the finalization of #ICHE6R3, clinical research is evolving, placing a stronger emphasis on #QualitybyDesign (QbD), risk-proportionate oversight, and trial efficiency. Risk-Based Quality Management (#RBQM) is no longer just a best practice—it’s an essential framework for ensuring compliance, improving data integrity, and prioritizing participant safety. In the 2024/2025 edition of Barnett International's Good Clinical Practice (GCP) A Question & Answer Reference Guide, edited by Just in Time GCP's Founder & CEO, Donna Dorozinsky, features a brand-new RBQM chapter—authored by Keith Dorricott — that dives into the practical steps, challenges, and regulatory expectations shaping today’s clinical trials. ?? What does this mean for you? ? Smarter risk assessment & trial oversight ? A proactive, rather than reactive, compliance approach ? Greater alignment with evolving global regulations Ready to explore how RBQM fits into ICH E6(R3) and the future of clinical research? Read more here and watch a video of Donna and Keith discussing the highlights - https://lnkd.in/g8YfaPjv #ClinicalTrials #RBQM #GCP #ICHE6R3 #RiskManagement #ClinicalResearch