The Risk-Based Approaches to Clinical Investigations compendia consists of conference presentation materials submitted by speakers and industry thought leaders
RELATED
- Snapshot Shows Targeted Site Monitoring Trend
- Risk-Based Approach to Monitoring
- Has FDA Guidance on Risk-based Monitoring Impacted SDV Coverage Yet?More in Risk-Based Monitoring
This Compendium consists of presentation materials submitted by speakers that complement their presentations from CBI’s Risk-Based Approaches to Clinical Investigations. CBI has provided information and networking opportunities for thousands of executives in industries such as pharmaceuticals, biotech, medical devices and managed care. We understand what an important resource this material is and we have made a concerted effort to secure biographical sketches, outlines and related materials from the conference.
View agenda from this past conference
PRESENTATIONS:
- Dean Gittleman MS, Senior Director, Operations, Target Health Inc.Read Bio
- Imogene Grimes Ph.D., Senior Director, Biostatistics, Otsuka Pharmaceutical Development & Commercialization, Inc. Read Bio
- Darlene Kalinowski, Associate Director, eDC Operations, Bristol-Myers SquibbRead Bio
- Jules T. Mitchel MBA, Ph.D., President, Target Health Inc.Read Bio
- Anne Marie Murphy, Principal, Hyman, Phelps & McNamaraRead Bio
- Mary Oster, Board Chair, New England Institutional Review BoardRead Bio
- Sharon S. Reinhard M.S., Associate Director, Compliance Operations & Oversight, Endo PharmaceuticalsRead Bio
- Vadim Tantsyura MS, MA, DrPh (c) Clinical Trial Operations Manager, Sanofi
- Vadim Tantsyura OpeningRead Bio
- Kerri Weingard NP, Research Director, Accumed Research AssociatesRead Bio
- Christian Yavorsky Ph.D. Chief Science Officer & Clinical Director, CROnos Clinical Consulting ServicesRead Bio
- Stephen Young, Senior Product Director, Medidata SolutionsRead Bio
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.