INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES
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![Artificial Intelligence AI Neural Network Concept with Lines and Binary Code-GettyImages-2197579271]( "Redesigning Regulatory Medical Writing For The AI Era")
Redesigning Regulatory Medical Writing For The AI EraFaster drafts aren't faster submissions. See how to apply AI across medical writing with the governance and human review regulators expect.
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![Test tubes, dropper, scientist in lab-GettyImages-2157720330]( "Accelerating Drug Development: Insights From 2020–2024 Rapid Approvals")
Accelerating Drug Development: Insights From 2020–2024 Rapid ApprovalsSome drugs reach approval in 3–5 years instead of 8–10. Learn which scientific, regulatory, and operational conditions can help your program cut avoidable delay.
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![GettyImages-2154021980-trial-payment-card-cost]( "The Cost Of Caution In Clinical Trial Participant Support")
The Cost Of Caution In Clinical Trial Participant SupportRegulatory uncertainty around participant payments can create practical barriers to participation. Explore how clearer protections can support appropriate reimbursement while preserving safeguards.
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![clinical-trial-study-design-GettyImages-2215843204]( "Harness An Adept IRB's Expertise To Streamline Study Design")
Harness An Adept IRB's Expertise To Streamline Study DesignAn Institutional Review Board protects human research participants by evaluating study ethics, consent, and risks, while providing sponsors with ongoing guidance on complex trial protocols.
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Scaling Pharmacovigilance: From Clinical Development to Commercialization10/1/2026
Commercial growth brings new PV challenges. Gain practical insights on operating models, technology, governance, and leadership for long-term success.
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The Future Of Clinical Trials: AI, Real-Time Data, And FDA Innovation9/30/2026
How does building trial protocols into health records lets key safety and efficacy signals reach sponsors and regulators in days, cutting manual data entry and speeding decisions.
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The Future Of Clinical Trials: 7 Trends Redefining FSP Models By 20309/29/2026
Learn why factors like decentralized trials and tighter global rules are pushing sponsors to favor fewer, deeply integrated, tech-driven partners over traditional staffing models for clinical outsourcing.
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ASCO To EHA 2026: From Incremental Gains To Early Impact: What Biotechs Must Do Next9/28/2026
Oncology is moving to earlier treatment. Learn how ASCO and EHA 2026 results can help you design faster, earlier-line trials that stay relevant as standards of care change and access gaps persist.
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Meeting The Complexities Of Modern ADC Development9/28/2026
A strong molecule is no longer enough. Learn how trial strategy and operational readiness can help your cancer therapy reach patients faster.
CLINICAL TRIAL REGULATORY SOLUTIONS
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![clinical-trials-tech-GettyImages-1867575053]( "Trial Transparency Starts Here")
Meet global requirements to share plain-language trial results with participants, replacing costly paper-based distribution.
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![medical experting meeting-GettyImages-2269325398]( "Simplify, Centralize, And Control Clinical Trial Disclosure With Ease, Flexibility, And Speed")
Centralize clinical trial disclosure management to simplify compliance, reduce submission errors, and speed up global reporting.
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![GettyImages-675233504 doctor tablet]( "Critical Insight For Global Clinical Trial Disclosure Compliance")
Managing clinical trial disclosure can be challenging with the ever-evolving regulatory landscape, and varying requirements across different jurisdictions and regulatory bodies. New and updated regulations need to be continuously monitored and assessed for potential impact on an organization, processes and overall strategy.
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![GettyImages-1923661781-asian-japanese-laptop-business]( "Accelerating Digital Endpoint Development Through Pre-Competitive Collaboration")
DECODE, the Digital Endpoint Collaboration for Outcomes Development, is Ametris’ pre-competitive collaboration framework designed to help address shared clinical measurement challenges across the life sciences industry. In regulatory contexts where evidence expectations are high, digital measures must be meaningful to patients, scientifically valid, operationally feasible, and aligned with regulatory expectations. By supporting the development and validation of fit-for-purpose, patient-centered digital measures, DECODE helps transform real-world data into validated clinical evidence across clinical research programs.
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![Protocol Builder And Informed Consent Builder]( "Protocol Builder And Informed Consent Builder Version 2.0")
Built by research compliance experts, this platform streamlines the protocol-writing process through customizable templates, workflow tools, and collaboration support for research teams.
REGULATORY MULTIMEDIA
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![Scaling Pharmacovigilance From Clinical Development to Commercialization]( "Scaling Pharmacovigilance: From Clinical Development to Commercialization")
Scaling Pharmacovigilance: From Clinical Development to CommercializationCommercial growth brings new PV challenges. Gain practical insights on operating models, technology, governance, and leadership for long-term success.
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![The Future Of Clinical Trials]( "The Future Of Clinical Trials: AI, Real-Time Data, And FDA Innovation")
The Future Of Clinical Trials: AI, Real-Time Data, And FDA InnovationHow does building trial protocols into health records lets key safety and efficacy signals reach sponsors and regulators in days, cutting manual data entry and speeding decisions.
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![Regulatory Affairs]( "Cell & Gene Unscripted: Regulatory Affairs")
Cell & Gene Unscripted: Regulatory AffairsOne platform, multiple payloads: how delivery systems can lower costs and boost access. Parexel experts break down the regulatory data that matters on Cell & Gene Unscripted.
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![Pre-Clinical]( "Cell & Gene Unscripted: Pre-Clinical")
Cell & Gene Unscripted: Pre-ClinicalRegulatory modernization is progressing, but harmonization gaps remain. Parexel's Chris Learn & Liz Spehalski dive into pre-IND strategy and precision therapies on Cell & Gene Unscripted.
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![GettyImages-1416816620 medical records, RWE]( "The Evidence Gap In Hematology: From Trial Endpoints To Patient Outcomes")
The Evidence Gap In Hematology: From Trial Endpoints To Patient OutcomesHematology trials face shrinking patient pools and fierce competition. Discover how real-world data and evidence can sharpen feasibility, site selection, and regulatory strategy.
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![Orexin-GettyImages-1336139745]( "A New Chapter for Orexin Therapies: What's Changing in Drug Development")
A New Chapter for Orexin Therapies: What's Changing in Drug DevelopmentJoin Beatrice Setnik, PhD and Denise Milova, PhD, for a conversation on orexin rescheduling and the evolving regulatory landscape.
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![Protocol Builder And Informed Consent Builder]( "Protocol Builder And Informed Consent Builder Version 2.0")
Protocol Builder And Informed Consent Builder Version 2.0Built by research compliance experts, this platform streamlines the protocol-writing process through customizable templates, workflow tools, and collaboration support for research teams.
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![Protocol Design Choices]( "Protocol Design Choices That Trigger IRB And Regulatory Requirements")
Protocol Design Choices That Trigger IRB And Regulatory RequirementsLearn how protocol choices like AI, adaptive designs, and decentralized methods impact IRB review, participant protections, consent, and key regulatory requirements in clinical research.
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![Story Behind MIDBA]( "The Story Behind MIDBA: An Exclusive Interview")
The Story Behind MIDBA: An Exclusive InterviewA new regulatory framework reduces PK bridging study needs, helping sponsors streamline device transitions, lower costs, speed up timelines, and boost regulatory predictability for combination products.
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![castor roi pmcf]( "PMCF Requirements: Questions On Cost, Device Viability, And Where AI Fits In")
PMCF Requirements: Questions On Cost, Device Viability, And Where AI Fits InPMCF costs are straining device budgets. Discover how AI-assisted review and real-world data from other regions can help you meet EU requirements more efficiently.
