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As a clinical trial site, have you looked at your ICH-GCP (E6) compliance lately, particularly from the R3 perspective? ✅ The good news is that it’s not aimed at rewriting the concepts again. So, basically, some may call it a facelift or transformation instead of an update. ⚠️ Challenging news is – It still requires you to review, assess, and redefine your perspective. Yes, perspective!! So, you start looking at every activity in trials through the lens of: Fitness of purpose – Asking one key question for each activity: Does this help generate reliable information to answer the research question and support decision-making while protecting trial participants? Quality by Design (QbD) – Don’t just generate quality data, but ensure to build quality into your protocol and processes. Risk proportionality – Focus on risks inherent in the clinical trial and the importance of the information collected. For investigators and sites, there’s another angle too! 📢 ICH-GCP now requires investigators to take greater responsibility for their clinical trials in a bigger manner, for instance, 🔄 “Investigator oversight” has been replaced by “investigator supervision.” Now, most of this perspective pertains to the protocol and trial procedures, except for one critical aspect: Ensuring build quality in your processes (QbD). - You can start to build quality in your processes by asking the question: Do you have defined standard operating procedures for your site? 📌 If not, now is the time to start preparing them. 📑 Need help with a template? Here’s one from Credevo that you can use: https://bit.ly/4k6zmTl 📩 Reach out to us if you need further support in developing your SOPs. Credevo - Let’s drive innovation in clinical trials together! 🚀 #ClinicalTrials #ClinicalResearch #ICHGCP 

📝 Clinical Trial Approvals in South Korea – A Quick Guide 1️⃣ Regulator: The MFDS (Ministry of Food and Drug Safety) manages drug and medical device approvals. 2️⃣ Approval Process: CTA (Clinical Trial Authorization) and IRB (Institutional Review Board) approvals are handled in parallel. 3️⃣ Timeline: Expect ~30 days for MFDS approval and ~50 days for IRB review. 4️⃣ Online System: Submit applications through the KiFDA e-registration platform for convenience. 5️⃣ Trial Registration: Register trials on CRIS (Clinical Research Information Services), part of the WHO registry. 6️⃣ Foreign Sponsors: Collaborate with a local CRO if you don’t have a presence in South Korea. 7️⃣ Compliance: Follow Good Clinical Practices (GCP) for all trials. 8️⃣ Import Requirements: Obtain import permits via the Korea Pharmaceutical Traders Association (KPTA). Simplifying clinical trial processes in South Korea has never been easier! Read in detail: https://lnkd.in/gPXzqZxt 📩 Questions? Reach out to us at inquiry@credevo.com. #ClinicalTrials #SouthKorea #DrugDevelopment #Credevo

🇯🇵 Thinking about clinical trials in Japan? Here’s what the numbers say! With an aging population (28.7% aged 65+) and a median age of 48.4, Japan offers a unique patient pool for trials targeting age-related diseases like cancer, cardiovascular conditions, and neurodegenerative disorders. 🌏 Key stats: ✅ 10,000+ trials conducted ✅ 70% Phase III success rate ✅ 5% annual growth in clinical trials Japan’s robust regulatory framework and high success rates make it a prime location for global research. Ready to explore its potential? Let’s connect and discuss. 💬 Dive deeper into the stats: https://lnkd.in/giZuNkBG #ClinicalTrials #ClinicalResearch #ClinicalTrialExecution #ClinicalTrialsAPAC #ClinicalTrialsJapan #AmericanPharma #USHealthcare #ClinicalTrialsUSA #USClinicalResearch

How Do Hybrid Clinical Trials Work? Hybrid clinical trials blend traditional in-clinic visits with decentralized methods, offering a flexible approach to research. ✔️ Use wearable tech for real-time, reliable data collection. ✔️ Enable home visits with traveling nurses and phlebotomists. ✔️ Train trial teams at scale with on-demand learning platforms. ✔️ Cater to diverse patient demographics efficiently. This approach ensures patient-centricity, wider reach, and seamless trial execution. Even regulators like the FDA are supporting these innovative designs! Read more: https://lnkd.in/gD7nP2Hk Curious about how hybrid clinical trials can work for your study? Reach out to Credevo—we're here to guide you every step of the way! #HybridTrials #ClinicalTrials #ClinicalResearch #ClinicalTrialExecution #ClinicalTrialsAPAC #ClinicalTrialsUSA #Credevo

🚦 Before you start your clinical trial, make regulatory feasibility your first and most crucial step! It’s not just about compliance—it’s about speed, safety, and success. 🚀 ✔️ Identifies regulatory gaps before they become roadblocks ✔️ Ensures ethical standards & patient safety 🏥 ✔️ Streamlines approvals for faster execution Balancing innovation with regulations is key to a smooth trial process! Read more: https://lnkd.in/gtPAxYJf 💡Navigating regulatory feasibility across different geographies can be challenging. Have questions? Reach out to our team #ClinicalTrials #RegulatoryAffairs #FeasibilityAssessment #ClinicalTrials #ClinicalResearch #ClinicalTrialsAPAC #ClinicalTrialsUSA #Credevo

1/3rd of Global Trials Start Here: USA’s Contribution to Global Health Solutions The USA stands tall as the leader in global clinical trials, hosting 35% of all trials globally. Why the USA? ✅ Well-Established Infrastructure: Advanced facilities equipped for diverse therapeutic areas, especially oncology. ✅Experienced Investigators: GCP-trained staff and a strong patient recruitment network. ✅ Efficient Timelines: Faster site activation and trial execution compared to global averages. The FDA's regulatory framework ensures rigorous standards for clinical trials, safeguarding quality and patient safety. From submitting an IND to gaining approval, the USA's process is streamlined and effective. Read more: https://lnkd.in/gpfSgA-H Planning to conduct clinical trials in the USA? Let us guide you through the process. #ClinicalTrials #GlobalResearch #ClinicalResearchUSA #ClinicalTrialExecution #ClinicalTrialsUSA #Credevo

Key considerations for implementing IOR & EOR services in clinical trials: ✔ Regulatory Compliance: Ensure every detail aligns with local and global standards. ✔ Logistics Management: Secure and efficient handling of clinical trial materials is vital. ✔ Cost-Effectiveness: Balance quality and budget with tailored solutions. ✔ Communication & Collaboration: Transparent teamwork is the backbone of success. ✔ Risk Management: Minimize and address risks proactively. IOR and EOR services are pivotal for trial success. Read more: https://lnkd.in/ghpdhAFY Let Credevo simplify the journey for you! #ClinicalTrials #IORServices #EORServices #ClinicalTrialsJapan #ClinicalResearch #ClinicalTrialExecution #ClinicalTrialsAPAC #Credevo

Do you know that CTAs in Japan don’t need formal approval? But they MUST meet key GCP requirements: Japan’s Clinical Trial Agreements (CTAs): Key Essentials! 🇯🇵 💼 Sponsor & CRO details 🏥 Medical Institution responsibilities 📜 Term & confidentiality clauses ⚖️ Indemnity for trial subjects Protect your trial subjects and ensure compliance with Japan’s PMDA regulations. Read More: https://lnkd.in/gbREkHz7 Secure success with Credevo’s expertise! #ClinicalTrials #JapanRegulations #PMDA #ClinicalTrials #ClinicalResearch #ClinicalTrialExecution #Credevo

How Can EDC Transform Clinical Trials? EDC systems are game-changers in clinical research! Here's how: ✅ Accurate Data: Minimize manual errors with real-time validation. 📂 Instant Access: Access critical data anytime, anywhere. 🔒 Secure & Compliant: Safeguard your data while adhering to GCP and 21 CFR Part 11 standards. ⏱️ Faster Outcomes: Streamline data collection and analysis to accelerate trial results. Read more: https://lnkd.in/g4UBww2w 💡 Want to see how EDC can make a difference in your trials? We’d be happy to walk you through it—reach out for a demo at your convenience! #ClinicalTrials #EDCSystems #DataManagement #MedicalResearch

🌍 Asia-Pacific: The Sweet Spot for Nutraceutical Research 🌿 Curious about the perks? Here's why you should focus on this region: 💰 Cost-effective trial management 🌍 Access to diverse patient populations ⚡ Faster regulatory processes Unlock these advantages to supercharge your next trial! 🚀 👉 Read more: https://lnkd.in/gjThur_F Contact @Credevo to conduct your Nutraceutical Clinical Trial in the Asia Pacific #Nutraceuticals #ClinicalTrials #AsiaPacific