The Risk-Based Approaches to Clinical Investigations compendia consists of conference presentation materials submitted by speakers and industry thought leaders
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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
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.