Integrity

Trust

Compliance

Transparency

Authenticity


Purpose

CALL FOR CONSULTATION   +1.724.272.1245

HOW WE TEACH

ACADEMY

 We love to teach and mentor on a variety of topics that are important in clinical research   and life science companies.


 Here are more examples of workshops, presentations, and teaching our academy has
 created content for:


  • Balance of Corporate and Regulatory Compliance - Industry Case Studies
  • Ethical Dilemmas
  • 21st Century Cures Act
  • Trial Master File (TMF) Inspection-Readiness
  • EHR-to-EDC Interoperability
  • ICH GCP E6
  • DHHS 45 CFR Part 46 
  • The Elements of Informed Consent 
  • OHRP Training on Federalwide Assurances (FWAs) and Individual Investigator Agreements (IIAs)
  • Lessons Learned: Phase III Rescue Study
  • Declaration of Helsinki, Belmont Report 
  • Risk-based Monitoring (RBM) and Risk-benefit assessments 
  • 21 CFR Part 11 Update 2017
  • HITECH, ARRA: American Recovery and Reinvestment Act of 2009
  • HIPAA and Privacy Laws
  • EUCOMED and ADVAMED Code of Ethics 
  • Emergency Research 21 CFR 50.24 
  • Emergency Use of a Non-Approved Device or Drug
  • Waiver of Informed Consent
  • Exempt Research 
  • Data Use Agreements
  • Honest Broker
  • Sunshine Law
  • ISO14155 
  • Speaker at MAGI Conference, November 2017, Building & Sustaining High Performance Teams: Human-Centered Design in Clinical Operations 
  • Adaptive Statistics in Clinical Research: A Sponsor's Case for Bayesian Statistics
  • Early medical product development, quality, regulatory, statistical and publications strategy 
  • What you need to know for changes to the ACA, 21st C Cures Act, ICH-GCP, and DHHS 45 Part 46 as they relate to research 
  • Life Science and CRO Careers
  • EMR-EDC Interoperability 
  • Audit and Inspection-readiness: for research sites, CROs, and sponsors


 And dozens of more topics.....