INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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![GettyImages-1269813787 mobile visit nurse]( "New Medicines, Novel Insights: Advancing Rare Disease Development")
New Medicines, Novel Insights: Advancing Rare Disease DevelopmentThis interactive report features insights from Parexel experts dedicated to patient-focused drug development, striving to expedite the market arrival of more rare disease treatments.
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![India Flag]( "Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection")
Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data CollectionExplore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.
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![GettyImages-525755915 clinical team eCOA]( "Improving Patient Health And Safety")
Improving Patient Health And SafetyEngage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.
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![GettyImages-862229772 communication]( "What Do Biostatisticians Think Of The ICH E9(R1) Addendum?")
What Do Biostatisticians Think Of The ICH E9(R1) Addendum?Gain insights from Kristina Bondareva, Head of Biostatistics at OCT Clinical, on the significance of the Addendum and the importance of adopting the estimand framework in clinical trials.
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Preparing Data Packages For Regulatory Submission7/23/2024
Gain insight into how a dermatology-specialized European CRO joined forces to carry out interim statistical analysis in its study on seven subjects and prepared necessary data packages for regulatory submission.
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ICH E9(R1) Addendum On Estimands And Sensitivity Analysis7/23/2024
Discover how the new framework will improve the way of designing and planning clinical trials and performing primary analyses and sensitivity analyses.
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Time-To-Event Analysis In Oncology Through The Prism Of Estimands7/23/2024
Considering an ICH E9R(1) Addendum on Estimands and Sensitivity Analysis, several sensitivity analyses are now regarded as supplementary analyses. Learn about these changes and their effects oncology trials.
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EU's New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?7/23/2024
The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.
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EU GMP Annex 1 – Navigating The Road To A Successful Annex 1 Inspection7/17/2024
The complexities of EU GMP Annex 1 inspections can be challenging. At an event hosted by NIBRT and Cencora PharmaLex, industry experts shared key insights and best practices for ensuring compliance.
CLINICAL TRIAL REGULATORY SOLUTIONS
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![Office-meeting-GettyImages-1353983621]( "Pre-Approval Inspection (PAI) Readiness")
Our team of experts are equipped to guide you through every step of any Inspection, especially Pre-Approval Inspections, due to the nature of their criticality.
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![Documentation Traps]( "Investigational New Drug Application Support")
When faced with industry pressures, companies turn to Halloran for essential support in their initial investigational applications. We provide a roadmap to ensure your product's market plan is grounded in expert guidance.
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![Personal data security-GettyImages-1172943967]( "GxP Data Integrity: Assessment, Readiness, And Compliance")
Our team comprises seasoned professionals in life sciences and regulatory compliance, offering tailored solutions for your unique data integrity challenges.
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![Sales Team]( "Wherever You're Going, Our Regulatory And Access Experts Have Been There")
With our consulting team by your side, comprised of over 1,000 dedicated professionals, you can be confident that your treatment’s journey from research to patient care is in expert hands.
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![GettyImages-1251666666 team of dcotors clinical]( "Maintain Control Over Your Regulatory Path And Mitigate Compliance Risks")
Our expertise spans the entire drug development process, navigating challenges posed by globalization, stakeholder engagement, scientific innovation, and payer expectations.
REGULATORY MULTIMEDIA
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![Vincent Cafiso_video_feature]( "What To Expect After An FDA 483")
What To Expect After An FDA 483Vincent Cafiso, a former FDA investigator, talks about what to do after an FDA inspection of your clinical trial site. “Don’t expect you’re not going to get a 483,” he says. But how you react to that 483 can deeply affect your company —possibly — for years to come.
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![Pharma’s Vital Interest In Tracking State Biosimilar Substitution Laws]( "ICH E9(R1) Addendum On Estimands And Sensitivity Analysis")
ICH E9(R1) Addendum On Estimands And Sensitivity AnalysisDiscover how the new framework will improve the way of designing and planning clinical trials and performing primary analyses and sensitivity analyses.
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![trialscopeintelligence]( "TrialScope Intelligence")
TrialScope IntelligenceThis easy-to-use platform reduces the risk of clinical trial disclosure noncompliance by tracking global disclosure regulations for you. Browse comprehensive regulatory authority and trial registry requirements.
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![PPD PV Partnerships thumb]( "Ensuring Effective PV Regulatory Intelligence With FSP Partnerships")
Ensuring Effective PV Regulatory Intelligence With FSP PartnershipsGain insights into what to look for in an FSP PV partner who can provide solid regulatory expertise and effective safety reporting across pharmaceutical, biotech, and medical device development.
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![Altasciences scheduling system]( "Moving In Unison: Proprietary Scheduling Platform")
Moving In Unison: Proprietary Scheduling PlatformJoin us for an exclusive discussion that uncovers the science behind our efficient management of key sponsor deliverables and critical milestones, driving our projects to success.
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![Plain Language Summaries Becoming A Mandate Worldwide]( "Plain Language Summaries Becoming A Mandate Worldwide")
Plain Language Summaries Becoming A Mandate WorldwideA growing number of countries are requiring clinical trial protocol and results disclosures that are written in plain language. These mandates should influence how these documents are authored from the start to minimize the need for redaction and anonymization.
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![How To Take Advantage Of Early Access Programs For The EU]( "How To Take Advantage Of Early Access Programs For The EU")
How To Take Advantage Of Early Access Programs For The EULearn how to leverage Early Access Programs (EAPs) in the EU to expedite market entry for innovative life science products. Gain insights into running successful EAPs, including crucial steps for France.
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![Exploring The Principles Integral To Rare Disease Drug Development]( "Exploring The Principles Integral To Rare Disease Drug Development")
Exploring The Principles Integral To Rare Disease Drug DevelopmentThis on-demand webinar offers valuable insights into successful rare disease drug development, including study design, regulatory engagement, and market access strategy.
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![Combination Products]( "US And EU Regulatory Expectations For Combination Products")
US And EU Regulatory Expectations For Combination ProductsExplore the regulatory nuances in the US and EU for combination products in this on-demand webinar. Key topics include differing regulatory requirements, the influence of new guidelines, and more.
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![medrio efficient trials thumb]( "Balancing Data, Technology, And Strategy In Clinical Research")
Balancing Data, Technology, And Strategy In Clinical ResearchHere, viewers will learn about best practices for developing an effective data collection strategy and selecting technology solutions that align with research needs.
