• Home
  • The MMS Difference
    • About Us
    • Leadership
    • Certifications
  • Services
    • Regulatory Affairs and Operations
    • Data Management and Biostatistics
    • Regulatory and Medical Writing
    • Drug Safety and Pharmacovigilance
    • Compliance and Transparency
    • Data Sciences
  • Working with MMS
  • News and Media
  • MMS Blog
  • Careers
  • Contact Us
MMS
Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?

Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?

by Don McLean | Feb 21, 2019 | Blog

Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed? by Barbara Rusin Part 1 of this medical histories series focused on the regulations relevant to clinical trial subject eligibility, and the possible issues...
Part 1: The Case for Better Health History Records – Regulatory Requirements

Part 1: The Case for Better Health History Records – Regulatory Requirements

by Don McLean | Aug 9, 2018 | Blog

Part 1: The Case for Better Health History Records – Regulatory Requirements by Barbara Rusin It is evident that during numerous audits, while working for the FDA and at MMS, clinical investigators are enrolling ineligible study subjects. A few of the ineligible...

Recent Posts

  • Dr. Mike Poole Joins the Board of Scientific Advisors at Top Global CRO MMS Holdings
  • Part 2: 505(b)(2) NDA – The Importance Early-Stage Planning
  • Part 1: 505(b)(2) NDA – Navigating the Regulatory Pathway
  • FREE DOWNLOAD: Lay Summary Whitepaper
  • MMS Holdings Leverages Medrio to Accelerate Clinical Trial Process for Study Sponsors Through New Contract

Tags

ALZ awareness Alzheimers big data biosimilars biostatistics Clinical Development clinical research clinical study reports clinical trials clinical trial transparency Community Compliance CRO data management data privacy data science drug development EMA ENDALZ FDA Flint GDPR GXP auditing Lay summaries leadership medical writing NDA submission opioids pharma pharmacovigilance PhUSE Policy 0070 quality control real world data regulatory operations REMS resourcing statistical programming suicidality transparency trial regulation Volunteering