INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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![Person using digital tablet-GettyImages-1421626437]( "The Transformative Role Of Digital Health Technologies")
The Transformative Role Of Digital Health TechnologiesDigital health technologies are transforming clinical trials through decentralization, improved data, and patient-centric approaches, driving efficiency and accessibility.
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![GettyImages-1002000796-lab-research-scientist-development]( "Multi-Regional Clinical Trials: The Latest Guidance From FDA")
Multi-Regional Clinical Trials: The Latest Guidance From FDAConducting multi-regional clinical trials (MRCTs) is essential for accelerating oncology drug development and ensuring broader patient access. However, differences across regions can impact findings.
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![Problem solving challenge achievement GettyImages-1271935835]( "Helping Biotechs Overcome 4 Key Challenges")
Helping Biotechs Overcome 4 Key ChallengesDelays in site payments, participant reimbursements, and logistical inefficiencies can create roadblocks for patients and sites.
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![laptop computer messaging]( "The Evolution Of Technology For Safety Notifications")
The Evolution Of Technology For Safety NotificationsDiscover how a digital-first approach empowers sponsors to optimize safety management and drive operational efficiency in an increasingly complex, global clinical landscape.
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Navigating The Future Of Clinical Trials: Expert Insights For 20252/26/2025
The biopharmaceutical industry is undergoing transformative changes to develop more dynamic and efficient frameworks that prioritize patient outcomes in 2025.
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Choosing The Right eClinRO Solution For Reliable Trial Data2/21/2025
Electronic clinician-reported outcomes (eClinROs) enhance the quality and consistency of clinical trial data. Discover key factors to consider when selecting an eClinRO provider.
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Comprehensive Services For Ophthalmic Drug Development2/20/2025
To maximize bioavailability while preserving vision and maintaining the structural integrity of the eye, formulation and delivery strategies must be meticulously designed.
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The Complexities Of Early Phase Ophthalmic Drug Development2/20/2025
Navigating the landscape of ophthalmic drug development can be challenging. Check out this scientific journal that outlines potential challenges, and how to overcome them.
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Alzheimer's Trials: Replacing Reams Of Paper For LAR Consent2/18/2025
Explore a structured solution to automate the Legally Authorized Representative (LAR) workflow, ensuring consent, reconsent, and assessments are accurately documented and compliant.
CLINICAL TRIAL REGULATORY SOLUTIONS
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![GettyImages-1384083899 consultant]( "Regulatory Consultancy Services")
Global Strategies to Align Your Goals With Regulatory Requirements
Ergomed’s regulatory consultancy services are guided by a team of seasoned consultants, each bringing a wealth of experience from regulatory agencies and in-house roles. This expertise ensures a proactive and flexible solution tailored to your project’s unique needs and timelines, instilling confidence in our services.
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![getty-1311598658-data-analytics]( "Harnessing Data For Deeper Insights In Medical Information")
Discover the groundbreaking software solution that your organization can leverage to meet industry demands by transforming vast amounts of raw data into actionable insights.
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![GettyImages-1388184871-quality-compliance-approval]( "Reviewing Protocols Across Therapeutic Areas: BRANY IRB")
A successful clinical trial starts with an efficient protocol review.
With deep roots in academic research and clinical medicine, BRANY IRB is uniquely positioned to meet your cost and speed requirements. Get your clinical trial to the start line while ensuring participant health and safety.
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![GettyImages-1137736725 data platform]( "Streamline Studies With The Right Virtual Clinical Trial Platform")
Scout Academy's virtual clinical trial platform streamlines operations, ensures enhanced compliance and audit readiness, offers integrated learning management, and features a user-friendly interface.
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![IQVIA]( "The Next Frontier In Early Phase Oncology Trials")
This session explores the pivotal role of First-in-Human and early phase oncology trials in drug development, emphasizing the importance of comprehensive planning for successful execution.
REGULATORY MULTIMEDIA
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![25_01_CLL_1280x720_Vid_Seg05]( "What Should You Ask The FDA About AI")
What Should You Ask The FDA About AIUnderstanding what some of the common questions the FDA gets about AI may help you as you plan to interact with the agency.
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![25_01_CLL_1280x720_Vid_Seg03]( "What Is 'Fit For Use' In AI Models?")
What Is 'Fit For Use' In AI Models?The data that you use to train AI models has to be “fit for use” according to the FDA. Tala Fakhouri explains what metrics the FDA uses to make this determination.
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![25_01_CLL_1280x720_Vid_Seg01]( "The FDA's View Of AI In Clinical Trials Is Limited")
The FDA's View Of AI In Clinical Trials Is LimitedTala Fakhouri explains that there could be so many more applications of AI in clinical development than what the FDA sees in regulatory submissions.
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![25_01_CLL_1280x720]( "AI In Action: Transforming Clinical Trials")
AI In Action: Transforming Clinical TrialsTala Fakhouri, associate director for data science and ai policy at the FDA, along with industry consultant Elena “Ella” Sinclair of FlexPoint Bio, talk about common applications of AI in clinical development and the new AI-focused regulatory Guidance from the FDA.
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![Digital-marketing-GettyImages-1051659276]( "Navigating The Digital Era And Beyond For Engaging Key Decision Makers In Specialty Pharmacy")
Navigating The Digital Era And Beyond For Engaging Key Decision Makers In Specialty PharmacyTune in as experts discuss how biopharma companies can effectively engage healthcare decision-makers in the evolving digital landscape.
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![isg whats wrong thumb]( "Uncovering The Root Cause Of Clinical Trial Troubles")
Uncovering The Root Cause Of Clinical Trial TroublesDiscover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.
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![Novotech Implementing Diversity webinar]( "Implementing A Diversity Plan For Your Clinical Trial")
Implementing A Diversity Plan For Your Clinical TrialIndustry leaders dive into the FDA’s Diversity Action Plans and practical strategies for integrating diversity action plans into clinical trial operations in a presentation centered around enhancing trial diversity.
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![Strategies For Research Institutions In An Evolving Era Of Oncology]( "Strategies For Research Institutions In An Evolving Era Of Oncology")
Strategies For Research Institutions In An Evolving Era Of OncologyAs biomarker-directed therapies drive advancements in the oncology space, experts are reviewing cutting-edge trends and strategies that help institutions address ethical and regulatory challenges.
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![24_10_CLL_1280x720_Seg05]( "The Benefits And Challenges Of Clinical Trial Standards And Automation")
The Benefits And Challenges Of Clinical Trial Standards And AutomationJessica Jolly discusses some of the benefits and challenges associated with implementing standards and automation in clinical trials.
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![24_10_CLL_1280x720_Seg03]( "How will the ICH M11 guideline impact future clinical trials?")
How will the ICH M11 guideline impact future clinical trials?Hassan Khalid of AstraZenca talks about how he sees the ICH M11 guideline impacting future clinical trials, specifically after a data lock.
