Early-phase clinical development is becoming increasingly complex, requiring sponsors to generate robust proof-of-concept data while navigating evolving study designs, diverse patient populations and increasing operational demands. Successfully accelerating proof-of-concept requires more than speed. It demands integrated scientific expertise, strategic planning and effective execution that reduces risk while delivering high-quality data to support critical development decisions.
The featured panelist will discuss practical strategies for designing and executing complex early-phase studies that help accelerate proof-of-concept and position programs for long-term success.
During this webinar, the speaker will explore:
- Strategies for designing efficient early-phase studies that generate meaningful proof-of-concept data
- Approaches to leveraging biomarkers and integrated data insights to inform earlier, more confident development decisions
- Best practices for managing operational complexity while maintaining data quality and regulatory confidence
- Real-world approaches to accelerating timelines without compromising scientific rigor
Whether planning a first-in-human study, optimizing an adaptive trial design or looking to strengthen early development strategy, this session will provide actionable insights to reduce development risk and support faster program progression.
Register for this webinar to learn how proof-of-concept strategies for complex early-phase studies can reduce development risk and support faster, more informed development decisions.
Speakers
Craig Boyle, DO, Vice President, Medical and Clinical Operations, Multiphase Sites, Trialmed
Craig Boyle is a Senior Medical Leader with 15+ years of emergency medicine experience and extensive involvement in early- and late-phase clinical research, currently serving as VP, Medical Lead for North America & Integrated Sites at Thermo Fisher Scientific.
He is a board-certified Emergency Medicine Physician and FACEP Fellow with a strong background in patient safety, protocol development, adverse event management and complex trial oversight across diverse therapeutic areas.
He is also an experienced Investigator in Phases I–IV studies, supporting programs in infectious disease, immunology, cardiovascular, metabolic, neurology, women’s health, hematology, dermatology and rare disease, among others.
Message Presenter
Aishwarya Vyas-Lahar, MD, Associate Medical Director, Trialmed
Board-certified Internal Medicine physician with 10+ years of clinical experience and experience across Phase I–III clinical research, currently serving as Associate Medical Director with a focus on early-phase drug development and clinical trial safety.
- Principal Investigator and Sub-Investigator across early- and late-phase clinical trials, with experience in first-in-human, SAD/MAD, dose-escalation, PK/PD, healthy-volunteer and patient studies, as well as specialized studies in lactating women.
- Experienced in subject safety, dose escalation, adverse event assessment and management, protocol feasibility, safety monitoring, and medical oversight throughout study conduct.
- Broad clinical and research experience across metabolic/endocrine disease, autoimmune and rheumatologic conditions, hematology, infectious disease including HIV and COVID-19, women’s health/lactation, and complex internal medicine, with a particular clinical interest in rheumatology and women’s health/lactation research.
Who Should Attend?
This webinar will appeal to:
- Clinical Operations leaders
- Clinical Trial Managers and Study Leads
- Patient Recruitment and Retention Specialists
- Site Engagement and Site Management professionals
- CRO and Sponsor Executives overseeing clinical development strategy
- Clinical Innovation, Decentralized Trials and Patient Experience leaders
- Biopharma and biotech professionals focused on improving trial performance and diversity
What You Will Learn
Attendees will learn how to:
- Design complex early-phase studies that efficiently generate meaningful proof-of-concept data
- Apply biomarker strategies and integrated data insights to support informed decision-making throughout early clinical development
- Overcome operational challenges while maintaining data quality, regulatory confidence and study efficiency
- Accelerate proof-of-concept through an integrated approach that helps reduce development risk and supports faster program progression
Xtalks Partner
Trialmed
Trialmed is the trusted clinical trial partner for patients, trial volunteers and sponsors/CROs. We facilitate clinical research as a care option for patients and healthy volunteers as a part of their health care journey. We create holistic experiences that put the patient first through our welcoming clinics, user-friendly digital technology, and our relentless focus on total quality delivery. Our patient-first approach makes Trialmed the clinical research destination of choice for patients and healthy volunteers. With extensive access to patients in the geographies where we operate, Trialmed ensures reliable enrollment outcomes that consistently meet or exceed sponsor expectations. We offer Home Trial Services for the ultimate in patient flexibility — conducting clinical trial visits where the patient prefers, such as the patient’s home, office or school. Our flexible clinical trial solutions scale to the sponsor’s needs and budget, offering a best-in-class early development services and site network from Phase I-IV.
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