• Home | Global Data CRO
  • Our Company
    • About Us
    • Executive Leadership
    • Board of Directors
    • Scientific Advisory Board
    • Global Leaders
    • Working with MMS
    • Certifications
  • Services
    • Regulatory Affairs
      • Regulatory Affairs Services
      • Regulatory Strategy Consulting
      • Regulatory Affairs Management
      • Regulatory Operations
    • Data Management and Biostatistics
    • Regulatory and Medical Writing
    • Transparency Services
      • Transparency and Disclosure Services
      • REGISTRATION AND RESULTS DISCLOSURES
      • Data and Document Anonymization
      • LAY SUMMARIES
    • Quality and Compliance services
    • Drug Safety and Pharmacovigilance
    • Rare Disease
    • Quality Control Services
    • Project Advisory Services
    • Data Science
  • Technology
    • Datacise
    • Automatiqc
    • PVantage
    • Technology Implementation
    • SmartStart Document Templates
  • Functional Services (FSP)
  • Webinars
  • News and Media
  • MMS Blog
  • Careers
    • MMS Careers
    • Opportunities
    • MMS Experience
    • MMS Culture
    • Global Benefits
    • FAQ
  • Learning
  • Contact Us
MMS Holdings
Whitepaper: Six Changes that Pharmaceutical Companies Should Consider in Response to COVID-19

Whitepaper: Six Changes that Pharmaceutical Companies Should Consider in Response to COVID-19

by Avery Zimmerman | Apr 8, 2020 | Blog

[Fill out the form below to access the whitepaper] In the wake of the global pandemic of COVID-19, also known and SARS-COV-2, regulators, health authorities, and lawmakers across the globe have rushed to implement countermeasures and develop best practices to curtail...
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 Avery Zimmerman | Feb 21, 2019 | Blog

Part 1 of this medical histories series focused on the regulations relevant to clinical trial subject eligibility, and the possible issues which can arise when ineligible subjects are enrolled. As noted, the outcomes vary depending on whether you are a clinical site,...
Part 1: The Case for Better Health History Records – Regulatory Requirements

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

by Avery Zimmerman | Aug 9, 2018 | Blog

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 subjects receive waivers before enrollment, however many do not. Ineligibility is often not clear...

Recent Posts

  • Award-Winning Data CRO Expands Executive Leadership to Support Company’s Next Stage of Growth
  • What is FDA’s Project Renewal? The Modernization of Decades Old Oncology Drug Labels
  • FDA Updates IND Expanded Access Guidance for Industry
  • What is Regulatory Information Management System (RIMS)?
  • Expanded Access to IND – Full Question and Answer in Draft Guidance

Tags

biostatistics Careers clinical research clinical study reports clinical trial disclosure clinical trials clinical trial transparency Compliance conference COVID-19 CRO data management data privacy data science decentralized clinical trials diversity and inclusion drug development eCOA & ePro EMA FDA Functional Service Provider (FSP) GXP auditing Health Analytics Collective innovation Lay summaries leadership medical writing MMS Academy NDA submission News Orphan Drug Designation Applications PDUFA VII pharmacovigilance PhUSE plain language summary Policy 0070 Praxis bioresearch quality and compliance quality control rare disease real world data regulatory affairs regulatory operations statistical programming transparency