Inspection Readiness: Before. During. After
This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.
How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
Streamline Study Startup with Improved Site Selection & Feasibility
Identifying the best prepared and performing sites for a study is essential to success. Explore strategies to improve site selection and feasibility.
A Guide for Successful Cell and Gene Therapy Research
Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.
Growth Mode: Developing a Fit-for-Purpose QMS Model
Learn successful strategies for a stepwise implementation of a clinical QMS, tailored to companies in growth mode.
Your Guide to sIRB Mandates
This webinar offers insights to your pressing questions related to single IRBs and explores the key features of federal sIRB mandates.
Beginner’s Guide to 21 CFR Part 11 Compliance
FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.
Regulatory, Clinical, and Quality Considerations for Device Research
Medical device manufacturers are facing increasingly complex pathways to successfully bring their innovative ideas to the market.
What Does an Endpoint Adjudication Committee (EAC) Do?
This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.
Budgeting for Single IRB Review
A practical discussion of budgeting considerations for sIRB review, including strategies for policies around external IRB reliance.
Regulatory and Ethical Considerations for eConsent in Research
If any part of your informed consent process involves an electronic component, you’re conducting eConsent.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.