Bispharm Clinical’s Post

Why Data Safety Monitoring Board (DSMB) is necessary in clinical trial conduct? DSMB is entirely independent of the trial and analyzes the study data for specific purposes. The board weighs the study-specific data against what is known about the health condition, study population and Investigational Product 😊 . DSMB monitors ongoing trial data to assess for; 🔸 Safety concerns. 🔸 Scientific integrity. 🔸 Strong interim data trends that could lead to unblinding

Unable to attend the FDA-MHRA-Health Canada Joint Symposium on Good Clinical Practices (GCP) this week? Day 1 key takeaways of what to expect in E6(R3): 📢 Greater emphasis on building QUALITY into clinical trial design 📢 Proportionate and risk-based approach to QUALITY management 📢 Target data governance activities that are critical to QUALITY 📢 Data lifecycle management and computerized systems controls that are risk proportionate 📢 Essential documents ---> Essential records Sponsors' highlight: "Importance of having leadership that promotes an open reporting culture, encourages investigation, and supports proportionate management of any critical errors." #GCP Slide credits - Session 4 - Good Data Governance Practices Update

Save the date for this webinar: On Differing Approaches to Measuring and Ensuring IRB Effectiveness October 17, 2024 12:00 pm to 2:00 pm EDT The Office for Human Research Protections (OHRP) and the FDA are co-hosting this public webinar to discuss differing approaches to measuring institutional review board (IRB) effectiveness. CARE-Q is a quality assurance program developed at the University of California and Stanford University to provide external, independent evaluation of IRB offices. Our goal is to assure that each IRB office has clearly written procedures for protecting human research participants that accurately conform to regulatory requirements and are being followed consistently. #CAREQ #IRBQuality #ResearchQuality https://lnkd.in/gFyk6ise

In early phase clinical trials, robust trial monitoring is essential to ensure the integrity, safety, and success of the study. Here’s how to implement effective monitoring practices: Key Aspects of Trial Monitoring: 🔵 Participant Safety: Continuous monitoring to safeguard participant well-being and address any adverse events promptly. 🔵Data Accuracy: Ensuring data collected is accurate and reliable for sound decision-making. 🔵Protocol Adherence: Verifying that trials are conducted in accordance with the approved protocol and regulatory requirements. Best Practices for Early Phase Trial Monitoring: 🔵Regular Site Visits: Conduct frequent on-site visits to review processes, ensure protocol compliance, and provide training. 🔵Comprehensive Training: Deploy a monitoring team which is thoroughly trained on the specific requirements of early phase trials as well as the regulations and guidelines which govern their conduct. 🔵Effective Communication: Maintain open lines of communication between monitors, site staff and sponsors to address issues swiftly. At QRC Consultants we offer expert trial monitoring services tailored to meet the unique needs of early phase trials, helping you achieve reliable and compliant study outcomes. #ClinicalTrials #TrialMonitoring #EarlyPhaseTrials #ClinicalResearch #PatientSafety #DataIntegrity

As the European Union progresses from the Clinical Trials Directive (CTD) to the Clinical Trial Regulation (EU No 536/2014, CTR), it is imperative for stakeholders to grasp the evolving safety reporting requirements. From January 31, 2025, the CTR will exclusively govern all clinical trials, superseding the CTD as per Article 98. Navigating the complexities of safety reporting during this transition can be challenging. Check out our new blog now....https://lnkd.in/gPaGsGne

Excited to share that I recently completed a comprehensive two-day workshop on Good Clinical Practice (GCP) 🌟 The workshop provided valuable insights into the principles and guidelines governing clinical research, ensuring the ethical conduct of trials and integrity of data. It covered essential topics such as protocol preparation, informed consent, participant safety, data management and regulatory compliance. #GoodClinicalPractice#ClinicalResearch Mujeebuddin Shaik

 The FDA has published a draft guidance on the 𝐔𝐬𝐞 𝐨𝐟 𝐃𝐚𝐭𝐚 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐂𝐨𝐦𝐦𝐢𝐭𝐭𝐞𝐞𝐬 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬. The guidance provides the Agency's current thinking for the role of data monitoring committees (DMC) on trial monitoring as well as on their principles of operation. The guidance pertains primarily to the sponsor’s responsibility for #clinicaltrialmanagement and decision-making but is also relevant to any stakeholders to whom the sponsor is delegating applicable #trialmanagement responsibilities. Historically, sponsors have not been required to set up DMCs when it is possible for an institutional review board #IRB to approve the trial without requiring #informedconsent from the trial participants or an independent DMC can be set up. If a sponsor decides to establish a DMC, it should come along with a process outlining its obligations, responsibilities, and #standardoperatingprocedures. The document is open for feedback from public until 13 April on www.regulations.gov under docket no. FDA-2001-D-0219. #datamonitoring #clinicalresearch #clinicaltrialdesign #datamanagement #clinicaldata #clinicaldatamanagement #clinicaltrials #DMC #clinicalsites #dataandsafetymonitoringboard #DSMB

What is “transparency-by-design” for clinical document disclosure? Watch our on-demand presentation + Q&A to find out: https://lnkd.in/gthCXpfz Since the 2023 relaunch of the European Medicines Agency’s Clinical Data Publication Policy (EMA Policy 0070), clinical trial sponsors have seen a marked uptick in regulatory requirements for clinical document publication.   Protecting the high volume of personal and commercially confidential information (CCI) in these documents can pose a significant challenge.   A great way for your organization to reduce its burden is by incorporating best practices in writing transparency-friendly clinical documents.   Watch Niamh McGuinness, PhD in this on-demand presentation covering:   • How to make your clinical documents transparency-friendly • How to incorporate best practices into your existing transparency initiatives • A complete solution for clinical document submissions to help you meet the demands of EMA Policy 0070—as well as EU CTR and Health Canada’s PRCI     Watch now => https://lnkd.in/gthCXpfz   #ClinicalTrialTransparency #ClinicalTrials #EMA

Today kicks off the DIA Clinical Trial Disclosure & Data Transparency Conference and our session on “Accelerating Clinical Trials Publication by Proactively Protecting CCI: Adapting to EU-CTIS Revised Transparency Rules.” Connect with Mark Bernath and speak with presenter Raina Agarwal, Associate Director of Clinical Trial Disclosure and Transparency at MMS as she dives into: 👉 How to protect CCI in applications 👉 Strategies for safeguarding confidential information 👉 Perspectives on adapting to new CTIS rules This session is a must-attend for anyone looking to stay ahead in clinical trial transparency and regulatory compliance. If you can’t make the event, message us here for a copy of the deck: https://hubs.li/Q02QLfvy0 #ClinicalTrials #Transparency #CCI #DIA2024 #CTIS #Compliance

⭐ New Blog Post: Unpicking the FDA’s Finalised Guidance on DCTs ⭐ The FDA has released its finalised guidance on decentralized clinical trials (DCTs), shedding light on how to effectively integrate remote elements, digital health technologies (DHTs), and service providers into your clinical research. But what does this mean for Quality Assurance Professionals and Clinical Operations Managers? In my latest blog post, we dive deep into: 🔑 Key challenges you’ll face when implementing DCTs 🧩 Best practices for managing multiple vendors and ensuring data integrity 📊 Risk management and monitoring strategies to maintain quality and compliance 👩🔬 How to design truly patient-centric trials that meet regulatory expectations 💡 Tips on adapting your processes to align with this new guidance If you're looking to stay on top of things and ensure your trials remain efficient, compliant, and patient-focused 👉 Check out the full post here: https://lnkd.in/eusSWDQU #ClinicalTrials #DCT #FDA #DigitalHealth #RiskManagement