Advanced Clinical Trials and Clinical Research

Adaptive trial models offer dynamic flexibility in clinical study design by allowing modifications based on interim data. This session explores the core principles of adaptive designs, including dose escalation, sample size re-estimation, and treatment arm adjustments. Attendees will gain insights into how adaptive trials can accelerate development timelines, reduce resource use, and improve decision-making. Regulatory perspectives from FDA and EMA on adaptive protocol acceptability will be addressed, along with statistical methodologies that ensure control of Type I error and preserve trial integrity. Case examples from oncology, rare diseases, and pandemic response trials will illustrate the power of real-time adaptations. Attendees will also learn about platform trials and Bayesian approaches. This session is ideal for researchers and sponsors aiming to integrate smarter, more efficient designs into their clinical development strategy.

Master protocols are revolutionizing clinical research by enabling the simultaneous evaluation of multiple interventions under a unified trial framework. This session covers the three main types of master protocols: basket, umbrella, and platform trials. Experts will explain how these designs can reduce duplication, optimize patient stratification, and accelerate therapeutic development, especially in oncology and infectious disease. Topics include protocol planning, operational execution, statistical modeling, and regulatory alignment. Attendees will examine real-world examples such as I-SPY, REMAP-CAP, and Lung-MAP, and learn how to implement master protocol infrastructure across sponsors, sites, and regulators. The session emphasizes benefits such as faster decision-making, shared control arms, and efficient resource allocation. Whether launching multi-arm studies or repurposing therapies, this session provides the strategic and technical insights needed to leverage master protocols successfully.

Real-world evidence (RWE) is playing an increasingly vital role in supplementing clinical trial data and supporting regulatory, reimbursement, and post-market decisions. This session explores the integration of RWE into trial design and execution, focusing on sources like electronic health records (EHRs), claims data, patient registries, and wearable devices. Attendees will learn how to design pragmatic trials, build hybrid datasets, and meet evolving FDA/EMA standards for RWE use. The session also covers statistical techniques for causal inference, bias mitigation, and external control arm creation. Through case studies from oncology, cardiology, and rare diseases, participants will understand how RWE contributes to population generalizability, faster approvals, and real-time surveillance. The session will also touch on the ethical and data privacy concerns related to real-world data use. Designed for trial designers, data scientists, and regulatory strategists, this session provides a practical roadmap to harnessing real-world insights for more effective and efficient clinical research.

Synthetic control arms (SCAs) offer an innovative approach to reduce or eliminate the need for traditional control groups, especially in rare diseases or high-risk indications. This session focuses on constructing and validating SCAs using real-world data (RWD), historical trial datasets, and statistical matching techniques like propensity scores and Bayesian models. Attendees will explore the advantages of SCAs, including enhanced patient recruitment, ethical considerations, and regulatory receptivity. The session highlights practical steps for identifying quality RWD sources, assessing comparability, and ensuring transparency in analysis. Discussions will include recent FDA/EMA decisions involving SCAs, challenges in data interoperability, and statistical robustness. Real-life use cases from oncology, gene therapy, and pediatrics will be reviewed. By the end of this session, participants will understand how synthetic controls can complement or replace traditional comparators while maintaining scientific validity and regulatory compliance.

Artificial intelligence (AI) is reshaping clinical research through automation, pattern recognition, and predictive analytics. This session explores how AI is applied across the clinical trial lifecycle, from protocol design and site selection to patient recruitment, data analysis, and risk prediction. Attendees will gain insights into machine learning (ML) models, natural language processing (NLP), and AI-based imaging tools that accelerate decision-making and reduce human error. Regulatory considerations for AI transparency, model validation, and algorithm bias mitigation will be covered. The session also discusses AI integration into electronic data capture systems, electronic medical records, and clinical trial management systems (CTMS). Real-world applications from oncology, neurology, and rare diseases illustrate AI’s role in enhancing trial efficiency, accuracy, and patient outcomes. Whether you are a data scientist, clinical researcher, or sponsor, this session offers actionable guidance for incorporating AI-driven tools into your trial strategy responsibly and effectively.

Blockchain technology holds transformative potential for clinical research by enhancing transparency, traceability, and data security. This session delves into how blockchain can be integrated into clinical trials to create immutable audit trails, improve patient data management, and streamline consent tracking. Attendees will explore smart contracts for automated protocol compliance and secure, decentralized platforms for storing sensitive clinical data. The discussion will also cover real-world implementations, such as tokenization of patient records and use in multi-center trial coordination. Experts will address regulatory concerns, interoperability with existing eClinical systems, and ethical considerations in decentralized data ownership. Case studies will highlight the practical applications of blockchain in reducing fraud, accelerating data sharing, and building trust among stakeholders. By the end of the session, participants will understand the key considerations, opportunities, and challenges in implementing blockchain solutions across clinical research workflows.

Digital therapeutics (DTx) represent a novel class of evidence-based, software-driven treatments for medical conditions. This session explores the unique aspects of designing and executing clinical trials for DTx, including endpoints validation, digital biomarkers, and real-time patient interaction monitoring. Attendees will learn how to address specific regulatory requirements, such as those from the FDA’s Digital Health Center of Excellence, and how to ensure compliance with software-as-a-medical-device (SaMD) frameworks. The session also highlights how patient engagement platforms, gamification, and adherence tracking can improve outcomes in digital health interventions. Case studies from behavioral health, chronic disease management, and neurological disorders will be shared. Special emphasis will be placed on trial design methodologies that suit iterative software updates and continuous learning systems. Whether evaluating a standalone app or a combination product, this session equips participants with a roadmap to conduct robust and compliant DTx trials that align with both clinical and digital development standards.

Wearable devices and remote monitoring tools are transforming how clinical trials collect real-time, continuous data on patient health. This session explores how wearables—such as smartwatches, biosensors, and portable ECG monitors—can be integrated into clinical trial protocols to track outcomes like heart rate, activity levels, glucose levels, and sleep patterns. Attendees will gain insights into selecting appropriate devices, validating their accuracy, and integrating data into electronic data capture (EDC) systems. The session also covers challenges such as data privacy, compliance with FDA and EMA guidelines, and interoperability with existing infrastructure. Use cases from cardiovascular, diabetes, and neurology trials will highlight the impact of remote monitoring on patient safety, retention, and overall trial efficiency. Participants will leave with practical strategies to harness wearables for improving data quality, reducing site visits, and enhancing patient-centricity in modern clinical research.

Virtual trial platforms are central to executing decentralized and hybrid clinical trials. This session examines digital infrastructures that support remote recruitment, eConsent, telemedicine, data collection, and patient engagement. Attendees will learn about leading platform functionalities, including real-time dashboards, automated scheduling, AI-driven alerts, and secure video conferencing tools. Key considerations include compliance with 21 CFR Part 11, HIPAA, GDPR, and integration with existing EHR and CTMS systems. The session will also cover vendor evaluation, interoperability, and data security protocols. Case studies will showcase successful implementation across therapeutic areas, with measurable improvements in trial timelines and patient adherence. With virtual trials gaining momentum, this session equips attendees with the knowledge to select, implement, and scale virtual trial platforms that support inclusive, efficient, and technology-driven research.

Risk-based monitoring (RBM) offers a modern, data-driven approach to clinical trial oversight by focusing resources on the most critical areas of risk. This session explores the principles and methodologies behind RBM, including centralized monitoring, key risk indicators (KRIs), and targeted source data verification (SDV). Attendees will learn how to develop risk management plans, use statistical algorithms for site prioritization, and incorporate real-time dashboards for efficient decision-making. The session also addresses regulatory guidance from FDA and EMA on RBM adoption and common implementation challenges. Real-world case studies will illustrate how RBM can enhance trial quality, reduce costs, and maintain compliance while improving overall operational efficiency. This session is designed for clinical operations leaders, quality managers, and data scientists seeking to modernize their monitoring strategies through a risk-based lens.

Advanced data analytics is revolutionizing clinical research by enabling faster insights, predictive modeling, and improved decision-making. This session delves into data mining techniques, AI-driven algorithms, and real-time analytics tools that support protocol optimization, patient stratification, and endpoint prediction. Attendees will learn how to leverage big data platforms, integrate data from diverse sources, and apply visual analytics to monitor trends and anomalies. The session also covers regulatory expectations for data traceability, reproducibility, and transparency. Real-world applications in oncology, rare diseases, and chronic care management demonstrate the value of data-driven strategies in enhancing both trial efficiency and scientific integrity. Participants will gain practical insights into implementing analytics-driven infrastructures, including dashboards, automation tools, and advanced statistical models. This session is ideal for trial sponsors, data scientists, and CROs aiming to drive performance and innovation through next-generation data capabilities.

Electronic Source (eSource) and Electronic Data Capture (EDC) systems are at the heart of efficient, high-quality data collection in clinical research. This session explores the design, implementation, and validation of eSource and EDC platforms, emphasizing regulatory guidance from FDA, EMA, and ICH GCP. Topics include system interoperability, real-time data entry, remote access, and user-friendly interfaces that support decentralized and hybrid trial models. Attendees will learn how to select the right technology stack, ensure 21 CFR Part 11 compliance, and mitigate common data entry and reconciliation issues. The session highlights best practices for training, vendor oversight, and audit readiness. Case studies will show how eSource integration with wearables, ePROs, and lab systems improves data accuracy, reduces lag time, and enhances overall trial efficiency. Whether upgrading systems or launching new trials, this session offers a roadmap for optimizing digital data collection infrastructure.

Maintaining data integrity and compliance is fundamental to the credibility of clinical research. This session examines key principles and regulations governing data quality, including ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete) standards, 21 CFR Part 11, and GxP guidelines. Attendees will learn how to design compliant workflows, conduct data audits, and implement role-based access controls to protect sensitive information. The session discusses common data integrity risks—such as transcription errors, unauthorized edits, and system malfunctions—and presents mitigation strategies through validation protocols and monitoring plans. Case studies from sponsor and CRO perspectives highlight real-world data integrity breaches and regulatory outcomes. By the end of the session, participants will understand how to build a culture of quality, foster accountability, and align operational practices with evolving global regulatory expectations.

AI-powered pharmacovigilance is transforming how safety data is detected, analyzed, and reported in real time. This session focuses on the use of machine learning and natural language processing tools to automate adverse event detection, signal prioritization, and risk assessment. Topics include integration with spontaneous reporting systems, literature screening, and social media mining. Attendees will learn about model validation, explainability, and compliance with ICH E2E and FDA regulations. The session also explores AI's role in predictive safety modeling, enabling earlier identification of potential risks. Real-world applications in post-marketing surveillance and clinical trial safety monitoring will be presented, along with challenges in algorithm bias and data source variability. Whether supporting internal safety teams or regulatory submissions, this session equips attendees with practical strategies for deploying AI responsibly in pharmacovigilance workflows.

Diverse participant enrollment is essential for generating generalizable, equitable clinical trial results. This session explores barriers to diversity—including socioeconomic, geographic, and cultural factors—and strategies to overcome them. Attendees will examine FDA and NIH guidance on inclusive enrollment practices and how to design protocols that accommodate underrepresented populations. Topics include community engagement, culturally tailored outreach, multilingual materials, and use of decentralized technology to reach rural or remote patients. Case studies will showcase successful diversity initiatives in oncology, cardiology, and vaccine trials. The session also discusses tracking demographic metrics, setting enrollment targets, and reporting outcomes to regulators and the public. Attendees will leave with actionable tools to implement inclusive recruitment plans that reflect real-world patient populations and promote health equity in research.

Patient-centric trial designs prioritize participant needs, preferences, and experiences to improve recruitment, retention, and adherence. This session covers methodologies for integrating the patient voice throughout the clinical development process—from protocol development to informed consent and follow-up. Topics include co-designing studies with patient advocacy groups, using patient-reported outcomes (PROs), and implementing flexible visit schedules or home-based assessments. Attendees will explore technologies that facilitate patient engagement, such as mobile apps, chatbots, and wearable devices. Case studies will illustrate how patient-centric approaches enhance satisfaction, data quality, and trial success rates. The session also examines the role of ethics committees in reviewing patient-centered protocols. Ideal for trial designers, CROs, and sponsors, this session provides a blueprint for embedding patient-centricity into every phase of research.

Navigating the global regulatory landscape is essential for multi-country clinical trials. This session provides an in-depth overview of international regulations governing drug development and clinical research, including FDA, EMA, PMDA, MHRA, and ICMR guidelines. Attendees will learn how to harmonize protocols, manage submissions through portals like CTIS and ClinicalTrials.gov, and address differences in ethics committee processes. Topics also include data privacy regulations (GDPR, HIPAA), regional GCP expectations, and timelines for trial approvals. The session will explore strategies for managing regulatory inspections, handling noncompliance, and preparing documentation to meet local and international requirements. Real-world examples of successful global trial execution will be shared. Whether planning regional expansion or navigating post-Brexit and post-pandemic regulatory shifts, this session offers critical guidance for ensuring regulatory alignment and study continuity worldwide.

eConsent solutions are revolutionizing the informed consent process by offering participants digital, interactive, and accessible formats. This session explores the design, deployment, and compliance requirements of eConsent systems across diverse populations and trial phases. Attendees will learn about multimedia integration, identity verification, and real-time tracking to improve understanding and documentation. The session also delves into retention tools such as mobile apps, reminder systems, and gamification techniques to maintain long-term engagement. Regulatory considerations from FDA, EMA, and IRBs will be covered, alongside data security and multilingual accessibility. Case studies highlight improved comprehension, reduced dropout rates, and operational efficiency gains. Ideal for sponsors, sites, and technology providers, this session provides actionable insights into leveraging digital consent and retention innovations for more participant-friendly and compliant trials.

Efficient clinical supply chains are crucial for delivering investigational products safely and on time. This session addresses innovations in supply planning, logistics, and temperature-controlled storage that are reshaping supply chain management. Attendees will explore technologies such as interactive response systems (IRT), real-time shipment tracking, and blockchain-enabled traceability. Topics also include forecasting demand, reducing drug wastage, and supporting decentralized trials through direct-to-patient delivery models. Case studies will demonstrate how adaptive supply chains enhance trial flexibility, patient access, and compliance with GDP and GMP standards. The session will also cover contingency planning for global disruptions and strategies to maintain chain-of-custody and product integrity. Designed for supply managers, CROs, and operations teams, this session equips stakeholders with tools to build resilient and responsive clinical trial supply ecosystems.