INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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![The Next Frontier In Early Phase Oncology Trials]( "The Next Frontier In Early Phase Oncology Trials")
The Next Frontier In Early Phase Oncology TrialsThis 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.
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![Parexel Expo Clip]( "Anticipating And Adapting At Every Step Of Development")
Anticipating And Adapting At Every Step Of DevelopmentReview how Parexel's Oncology Site Alliance Network can support the accelerated timelines and flexibility required in early phase oncology studies.
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![Avance-Clinical]( "Oncology Clinical Trials Key Considerations - Planning For Success")
Oncology Clinical Trials Key Considerations - Planning For SuccessDelve into key strategies for conducting successful early-phase oncology trials for biotechs.
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![GettyImages-1257716223 fda guide]( "483 Issues To Sites – Indicators Of Sponsor Oversight Effectiveness")
483 Issues To Sites – Indicators Of Sponsor Oversight EffectivenessExplore how effective oversight is critical for companies addressing Form 483 observations identified during clinical study site regulatory inspections.
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The Importance Of Diversity In Clinical Trials10/16/2024
A recent FDA draft guidance aims to address health disparities and enhance data quality with action plans for greater inclusivity in clinical trials. Explore practical steps to building trust and inclusivity in clinical research.
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Cell and Gene Therapies – Global Clinical Trial Landscape (2024)10/15/2024
The landscape of cell and gene therapy is advancing rapidly, revolutionizing healthcare by offering novel treatments for cancer, rare genetic conditions, and hematological diseases.
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From Crisis To Confidence In Medical Writing: Ensuring Smooth Regulatory Submissions10/8/2024
Explore some of the major challenges that medical writing submission specialists face today and present strategies that can consistently set the stage for success.
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The Complex Road To Developing Targeted Therapies10/3/2024
Developing targeted therapies is a complex journey, requiring a deep understanding of disease, innovative approaches, and close collaboration with experts.
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Regulatory Divergence Presents Barriers To EU Combined Studies10/3/2024
EU regulatory divergence creates hurdles for combined studies of medical devices, IVDs, and drugs. The COMBINE project aims to streamline the process and encourage more combined studies in Europe.
CLINICAL TRIAL REGULATORY SOLUTIONS
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![GettyImages-10977380780 science-liquid-beaker]( "How Do Life Sciences Companies Benefit From NetSuite SuiteSuccess Implementations?")
Sikich is revolutionizing the life sciences sector with its innovative SuiteSuccess for Life Sciences bundle. This automated approach streamlines processes, strengthens financial controls, and accelerates readiness for Equity Events/Sox Controls, and much more.
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![GettyImages-466728721 quality]( "GxP Quality Assessment And Remediation")
Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.
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![Field Service Consultants]( "Advertising & Promotional Review Consulting")
ProPharma has built the world’s leading and first full-service global solution dedicated to Advertising & Promotional Review.
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![Europe iStock-490822468]( "European Regulatory Development")
Scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes.
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![Doctors talking-GettyImages-600403420]( "FDA Regulatory Consulting")
Our goal is to help your business succeed by working with you to streamline the FDA regulatory process. ProPharma’s team of science- based regulatory consultants commands an unparalleled breadth and depth of knowledge pertaining to FDA’s regulatory framework and can work with you to accomplish your business objectives.
REGULATORY MULTIMEDIA
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![The Next Frontier In Early Phase Oncology Trials]( "The Next Frontier In Early Phase Oncology Trials")
The Next Frontier In Early Phase Oncology TrialsThis 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.
-
![Parexel Expo Clip]( "Anticipating And Adapting At Every Step Of Development")
Anticipating And Adapting At Every Step Of DevelopmentReview how Parexel's Oncology Site Alliance Network can support the accelerated timelines and flexibility required in early phase oncology studies.
-
![Avance-Clinical]( "Oncology Clinical Trials Key Considerations - Planning For Success")
Oncology Clinical Trials Key Considerations - Planning For SuccessDelve into key strategies for conducting successful early-phase oncology trials for biotechs.
-
![ISG crisis to confidence web thumb]( "From Crisis To Confidence In Medical Writing: Ensuring Smooth Regulatory Submissions")
From Crisis To Confidence In Medical Writing: Ensuring Smooth Regulatory SubmissionsExplore some of the major challenges that medical writing submission specialists face today and present strategies that can consistently set the stage for success.
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![FDAs Vision On PRO Collection For RWE]( "FDA's Vision On PRO Collection For RWE")
FDA's Vision On PRO Collection For RWEIn this presentation, a distinguished panel of experts illuminates the crucial role of patient-reported outcomes (PROs) in shaping regulatory decisions and drug development strategies, particularly in light of FDA expectations.
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![24_09_CLL_1920x1080]( "The Diversity Mandate: Effective Strategies in Clinical Trials")
The Diversity Mandate: Effective Strategies in Clinical TrialsThe June 2024 release of the FDA’s guidance related to diversity in clinical trials gives more direction to the industry on this ongoing concern and details what trials need Diversity Action Plans (DAPs), what should be included, and how to submit them. Will this be the turning point that shifts the conversation surrounding diversity from marketing rhetoric to actual implementations?
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![TMF Excellence]( "TMF SUMMER SHORTS: House Of The Inspector")
TMF SUMMER SHORTS: House Of The InspectorDiscover key steps you can take to not just survive an inspection, but take the TMF Throne.
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![Ask The Experts]( "Unlock The Secrets Of Managing CTR In A Complex Development Landscape")
Unlock The Secrets Of Managing CTR In A Complex Development LandscapeLost in the CTR maze? Watch this webinar to get your burning questions answered by industry experts. Ask about vendor coordination, CTIS integration, and EU strategies.
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![TMF Excellence]( "Risk-Based Quality Review: Inside Out")
Risk-Based Quality Review: Inside OutWalk through how to manage and resolve the often conflicting internal and external directives to find the right path for you.
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![altasciences podcast manufacturing thumb]( "Overcoming The Challenges Of Manufacturing And Clinical Trials")
Overcoming The Challenges Of Manufacturing And Clinical TrialsDiscover how CROs and CDMOs tackle operational and regulatory challenges for pharmaceutical and biotechnology companies, and how this can be the key to study success or failure.
