INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• How Sponsors Are Responding To FDA's RTCT Request For Information

  Let's take a look at where continuous, real-time regulatory review can meaningfully speed drug development, and where it likely won't help much.

• Cross-Functional Best Practices For Signal Detection In Special Case Scenarios

  When trial data fall short, real risk signals surface in inquiries, complaints, and reports. Learn how coordinated, cross-functional practices help catch risk earlier.

• Strategic ADC Development In A Shifting Regulatory Landscape

  As ADC development grows more complex, sponsors must align safety, dose optimization, global trial design, regulatory strategy and CMC readiness early to reduce risk and accelerate approval.

• The Rise Of Chinese Biotechs And The Global CRO Question

  As innovative therapies move beyond home markets, early planning across regulators and geographies helps avoid costly delays and protect trial budgets.

• How Modern Logistics Support Belmont And HHS OIG Goals

  8/24/2026

  Participant support can expand trial access, but regulatory uncertainty limits adoption. A safe harbor could enable reimbursement and compensation while protecting against coercion and undue influence.

• Psychedelic Drug Trials: Are Your Sites Ready?

  8/24/2026

  Psychedelic trials require unique operational approaches. Learn how to address patient safety, blinding, specialized assessments, and therapeutic setting considerations.

• FDA Finalizes Psychedelic Drug Guidance: What Sponsors Need To Know

  8/24/2026

  FDA's July 2026 final guidance on psychedelic drug clinical investigations sets expectations for sponsors developing psilocybin, LSD, and MDMA therapies. Learn what it means for your program.

• Advancing IHC Assays From RUO To Clinical Trials And CDx

  8/21/2026

  Examine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.

• PMCF Requirements: Questions On Cost, Device Viability, And Where AI Fits In

  8/20/2026

  PMCF 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.

REGULATORY MULTIMEDIA

• Protocol Design Choices That Trigger IRB And Regulatory Requirements

  Learn how protocol choices like AI, adaptive designs, and decentralized methods impact IRB review, participant protections, consent, and key regulatory requirements in clinical research.

• The Story Behind MIDBA: An Exclusive Interview

  A 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.

• PMCF Requirements: Questions On Cost, Device Viability, And Where AI Fits In

  PMCF 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.

• How Regulators Are Setting Standards For Digital Health Technologies

  Digital health tools are changing clinical trials fast. See how regulators and researchers are keeping evidence rigorous and trial-ready.

• Speed Kills: When Timelines Trump Science In Neuropsychiatric Trials

  This Bold Conversation brings together experts helping to define the next chapter of psychedelic clinical research to unpack lessons from recent regulatory reviews and explore what clinical teams need now.

• Building the Blueprint: What Psychedelic Trials Need Now

  Discover how leading experts are addressing recent regulatory reviews to shape the next phase of psychedelic clinical research.

• The Fastest Route To Compliant Medical Device Trials

  Watch a live build of compliant eCRFs and ePROs and see how lean teams can go from protocol to first patient faster without sacrificing regulatory readiness.

• The Evolution Of GLP-1s: Overcoming Clinical Development Challenges

  Explore clinical development trends, recruitment hurdles, study design strategies, and emerging therapies shaping obesity and metabolic disease research.

• Unifying Research - HRPP Vs IRB And Participant Christine

  HRPPs and IRBs play different but connected roles in protecting research participants. Hear expert guidance, firsthand experiences, and questions that can help people make more informed decisions.

• Unifying Research - Research Administration And Participant Caregiver

  Go behind the scenes of cancer clinical trials operations and hear a caregiver’s perspective on supporting a research participant, including the challenges, needs, and opportunities.