How to avoid common study conduct mistakes and save costs

Running clinical trials isn’t just science it’s structure, precision, and relentless attention to detail. And at the center of it all? Clinical Research Coordinators (CRCs) who make every protocol, every visit, and every data point count. From managing documentation to ensuring patient safety and compliance, CRCs are the backbone of every successful study. Reliable results don’t happen by accident they happen because someone is coordinating them with excellence. At CINOR Clinical Research, we honour the work behind the scenes while delivering what sponsors trust the most: Precision. Reliability. Results. 📌 Follow us for more real-world clinical insights, industry updates, and behind-the-scenes expertise. #ClinicalResearch #ClinicalTrials #CRCLife #ResearchCoordinators #CROInsights #ClinicalOperations #CinorClinical #GoodClinicalPractice #ClinicalExcellence #MedicalResearch #LifeSciences #ResearchProfessionals

Phase II vs Phase III — The Difference Most CRAs Overlook 👇 A lot of people think Phase II and Phase III studies are “basically the same.” Here’s the breakdown most new CRAs wish they learned earlier: 🔷 Phase II — The “Is This Even Working?” Stage ✅ Sample size: ~100–300 ✅ Goal: Detect early efficacy + refine dose ✅ Monitoring focus: Early safety signals Protocol amendments Dose-finding accuracy ✅ Challenges: High amendments, inconsistent dosing, unpredictable AE patterns This is where a CRA learns to think clinically — not just operationally. 🔶 Phase III — The “No Room for Mistakes” Stage ✅ Sample size: 300–3,000+ ✅ Goal: Confirm efficacy & compare with Standard of Care ✅ Monitoring focus: Endpoint accuracy Large-scale data consistency Serious compliance checks ✅ Challenges: Patient retention, multi-country coordination, enormous site workload Here, a CRA becomes an investigator’s true partner — not just a monitor. 💡 Why it matters Each phase demands a completely different mindset. If you understand the operational + scientific expectations of both, you’ll manage sites smarter and deliver cleaner data with fewer queries. That’s what separates a “good” CRA from a great one. 🔍 Curious to know… Which phase are you working on right now, and what’s the biggest challenge you face?

The October issue of Clinical Researcher focuses on “Empowering the People Behind the Processes,” offering up a collection of insights on how humans impact the inner workings of clinical trials and vice versa. We hear from a variety of professionals who delve into such areas as the attitudes of primary/urgent care providers toward trials; the importance of productive interrelationships between sponsors, CROs, and sites; the many, and often misunderstood, duties of institutional review boards; the changing role of clinical research associates in technology-driven environments; and more. Read the full issue >> https://bit.ly/3L3d8og #ClinicalResearcher #ACRP #Journal #ClinicalResearch #ClinicalTrials #ClinicalResearchPartnerships #ClinicalPharmacology #InstitutionalReviewBoards #IRBs #CRA #ClinicalResearchAssociate

The Indian Society for Clinical Research (ISCR) continues its monthly webinar series designed exclusively for Clinical Research Coordinators (CRCs). This session will help CRCs strengthen their understanding of adverse event (AE) and serious adverse event (SAE) reporting. Learn how to confidently identify, document, manage, and report AEs and SAEs while ensuring accuracy and regulatory compliance. Topic: Managing AEs & SAEs – Including Reporting and Procedures Date: 21st November 2025 Time: 4:00 PM – 5:00 PM (IST) Format: Virtual Register here: https://lnkd.in/gf7rzNMt This is a complimentary webinar. Certificate: Certificate of Participation will be provided via email post-event. Webinar Objectives: Through real-world scenarios and expert-led discussions, this session will enable CRCs to: • Recognizing and categorizing AEs and SAEs • Understanding regulatory requirements and timelines • Navigating documentation and reporting workflows at Sponsor & Site level • Navigating SAE reporting on eSUGAM • Collaborating effectively with investigators and sponsors. Please find the flyer attached for your reference. We look forward to your participation in this engaging and insightful learning Session. For any queries, feel free to reach out to info@iscr.org

Clinical research is evolving, and so is the role of the CRA. As trials grow more complex, leading sponsors are shifting CRAs from traditional compliance monitoring to proactive, data-driven site support. With the right tools, training, and technology, today’s CRAs can: ✅ Detect risks before they become issues ✅ Focus on what truly drives site performance ✅ Build stronger, more strategic site partnerships 💡 Read The Modern CRA: Operationalizing Data-Driven Site Success by Ken McFarlane and Sas Maheswaran in ACRP to see how data and empathy are redefining the future of clinical research. https://hubs.ly/Q03PHDs40 #ClinicalResearch #RBQM #CRA #ClinicalTrials #CluePoints

🧛♀️ Spooky Season at the Site: 5 Clinical Research “Don’ts” That Haunt Me 🎃 When I was a site coordinator, I had seen my share of scary moments—but nothing chills me like these clinical research missteps. Let’s keep our trials treat-worthy, not terrifying: 🕸️ 1. Don’t Vanish After Site Initiation We need sponsors and CROs to stay visible. Ghosting us post-kickoff? That’s how timelines die. 🕷️ 2. Don’t Skip the Consent Ritual Informed consent isn’t optional—it’s sacred. Rushing through it invites regulatory poltergeists. 🧟♂️ 3. Don’t Let Protocols Become Zombies If your protocol’s too rigid to adapt, it’ll stumble through the study like the undead. Flexibility = survival. 🦇 4. Don’t Unleash Budget Beasts Unclear payment terms and delayed reimbursements? That’s how site morale gets drained. 🪦 5. Don’t Bury Participant Experience We’re not just collecting data—we’re building trust. Ignoring patient feedback is a grave mistake. 🧙♀️ From one site to another: let’s keep our studies compliant, compassionate, and far from cursed. Happy Monday—and happy haunting from the front lines of research!

The Indian Society for Clinical Research (ISCR) continues its monthly webinar series designed exclusively for Clinical Research Coordinators (CRCs). This session will help CRCs strengthen their understanding of adverse event (AE) and serious adverse event (SAE) reporting. Learn how to confidently identify, document, manage, and report AEs and SAEs while ensuring accuracy and regulatory compliance. ✏️ Topic: Managing AEs & SAEs – Including Reporting and Procedures 📅 Date: 21st November 2025 🕑 Time: 4:00 PM – 5:00 PM (IST) 💻 Format: Virtual 🔗 Register here: https://lnkd.in/gscwGzk4 Webinar Objectives: Through real-world scenarios and expert-led discussions, this session will enable CRCs to: ✏️Recognising and categorising AEs and SAEs   ✏️ Understanding regulatory requirements and timelines  ✏️ Navigating documentation and reporting workflows at the Sponsor & Site level ✏️ Navigating SAE reporting on eSUGAM   ✏️ Collaborating effectively with investigators and sponsors. For any queries, reach out to info@iscr.org Shetal Lotia, Rajendra Kshirsagar, Renuka Neogi, Shweta Pradhan, Pradnya, Sangita Singh

🇬🇧 The UK’s Clinical Trials Framework is getting an update Earlier this month, the MHRA and HRA published their final guidance ahead of major legal changes to how clinical trials will run in the UK from 28 April 2026. This marks the most significant update since 2004 and it’s designed to make research faster, more transparent, and less burdensome for sponsors and sites. Here’s what’s changing and why it matters: 𝗕𝗲𝘁𝘁𝗲𝗿 𝗰𝗼𝗼𝗿𝗱𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗠𝗛𝗥𝗔 𝗮𝗻𝗱 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗘𝘁𝗵𝗶𝗰𝘀 𝗖𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲𝘀 → A single, streamlined review process instead of fragmented oversight 𝗚𝗿𝗲𝗮𝘁𝗲𝗿 𝘁𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝗰𝘆 𝗼𝗳 𝗿𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀 → Public access to trial decisions and easier data sharing 𝗥𝗲𝗱𝘂𝗰𝗲𝗱 𝗮𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝘃𝗲 𝗯𝘂𝗿𝗱𝗲𝗻 𝗳𝗼𝗿 𝘀𝗽𝗼𝗻𝘀𝗼𝗿𝘀 → Clearer guidance, simpler submissions, and more proportionate safety reporting 𝗔 𝘆𝗲𝗮𝗿 𝗼𝗳 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 𝘁𝗼 𝗽𝗿𝗲𝗽𝗮𝗿𝗲 → The new framework takes effect from April 2026, giving researchers time to adapt systems and SOPs The message is clear: the UK wants to remain a world leader in clinical research but with a system that’s more agile, transparent, and innovation-friendly. If you’re running or planning a clinical trial in the UK, now’s the time to review your protocols, governance processes and documentation. 📄 Read the full MHRA/HRA blog here: https://lnkd.in/ebbGeEAz

My 4-Step Framework for Smooth Clinical Trial Visits Over time, I developed a simple workflow that helps me run study visits without chaos: 1️⃣ Pre-Visit Prep Review eligibility, lab results, previous visit notes, drug accountability. 2️⃣ Clear Communication Explain every step in simple language — no medical jargon. 3️⃣ Accurate Data Capture Vitals, source notes, CRF entries… everything must align. Research is unforgiving with errors. 4️⃣ Follow-Up & Retention Care A reminder call, checking tolerability, and making participants feel valued. This framework has saved me time, reduced errors, and improved participant satisfaction. #NursingResearch #ConsistencyMatters #GrowthMindset #showupandgetseen #30dayslinkedlnchallenge

Success in clinical trials is engineered, not imagined. It’s not luck. It’s not chance. It’s precision built step by step. From site selection to patient recruitment... Every element shapes the outcome. A small gap in training, oversight, or engagement can ripple into months of delay and lost credibility. But when systems, people, and processes align, trials don’t just run, they succeed. That’s why we’ve outlined the 5 essential pillars for a successful clinical trial, practical, proven, and built for real-world challenges. Because great research deserves equally great execution. And at Interim Visits, we’re here to make that happen. Follow Interim Visits for more stories that power smarter, faster, and more reliable clinical research. #ClinicalTrials #ResearchExcellence #DataIntegrity #LifeSciences #InterimVisits