• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Authors » Leslie Ramsey

Leslie Ramsey

Articles

ARTICLES

Priorities-360x240.png

Priorities at Sites Change as Trial Landscape Becomes More Challenging

April 25, 2022
Leslie Ramsey
The effects of the pandemic — trial delays, staff shortages and backlogs of trials waiting to start — have led sites to change their priorities in recent years and think differently about how to conduct trials. Read More
Standards-360x240.png

New Standards Needed to Close Cybersecurity Risk Gaps in Clinical Trial Agreements

February 14, 2022
Leslie Ramsey
Sites and sponsors may think they have their master clinical trial agreement (CTA) terms and clauses locked in, but protection against data breaches is seldom one of the concepts covered adequately, if at all. Read More
AdverseEvents-360x240.png

Stop Over-Reporting Adverse Events, FDA Officials Tell Sponsors

June 14, 2021
Leslie Ramsey
Sponsors and sites need to do a better job analyzing suspected adverse events before sending reports to the FDA, say two senior agency officials, who fear that the current over-reporting they see may lead to missing important safety signals. Read More
Customization-360x240.png

Sites Will Be Operating in a World Focused on Customization After the Pandemic

April 26, 2021
Leslie Ramsey
A clear focus on hybrid solutions and customization to a site’s needs will be the hallmarks of clinical trials postpandemic, along with a strengthened ability to shorten trial timelines. Read More
Outlook2021-360x240.png

COVID-19 Not the Only Factor in Trial Industry’s Outlook for 2021

December 8, 2020
Leslie Ramsey and Suz Redfearn
As the clinical trials industry looks back on what has been an incredibly disruptive year, questions are being raised about what to expect in 2021. One thing is certain: a return to normalcy is not in the cards although there is cause for hope about how COVID-19 has altered the clinical trials landscape. Read More
Analysis-360x240.gif

Making Coverage Analysis Determinations for Outside-the-Box Situations

December 7, 2020
Leslie Ramsey
There’s no getting around making careful coverage analysis (CA) determinations. It’s an essential part of what sites need to do to stay compliant on billing practices. However, questions do arise in areas where there is little to no guidance. Here is an overview of some of those problem areas and what experts suggest are possible solutions. Read More
Diversity-360x240.png

FDA Guidance Signals Clear Support for Efforts to Increase Trial Diversity

November 16, 2020
Leslie Ramsey
As part of its ongoing efforts to make clinical trials more representative of the population, the FDA last week issued a final guidance on what sponsors should do to make trials more accessible and appealing to under-represented racial, ethnic, gender and age groups. Read More
Virtual Doctoer

Simple Changes Can Make Trials More Patient Friendly

November 16, 2020
Leslie Ramsey and Charlie Passut
Industry experts agree that 100 percent virtual trials won’t work for all types of studies, but they predict that by 2025, all trials will have at least some virtual component that offers flexibility in how sites interact with participants and makes trials more accessible and more appealing to the public. Read More
Questions-360x240.png

Questions of Cost, Accountability Dominate Discussion of Trials’ Post-Pandemic Future

November 9, 2020
Leslie Ramsey
As the industry moves beyond the pandemic, sites and sponsors must ask themselves which practices developed to meet the needs of remote operations should carry forward and, ultimately, who will cover the cost of new technology and methods. Read More
Challenge-360x240.png

Site Crunch Challenges Made Worse by Pandemic, Eased with Sponsor Engagement

November 2, 2020
Charlie Passut and Leslie Ramsey
Sites are being asked to do more with less as revenues and resources decrease at the same time sponsor demands for COVID-related trials increase. But altering the dynamics between sites and sponsors may be part of the solution. Read More
View All Articles by Leslie Ramsey

Upcoming Events

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

  • 16Oct

    WCG MAGI's Clinical Research Conference 2022 West

  • 16Nov

    17th Annual FDA Inspections Summit

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Options-360x240.png

    Cancer Patients Signal Interest in Less Travel, More Remote Trial Options

  • SurveywBlueBackground-360x240.png

    New Study Shows Trends in Funding, Racial Balance Amidst COVID-19

  • Complexity-360x240.png

    Rising Trial Complexities Create More Payment Problems, Frustrations for Sites

  • Challenge-360x240.png

    BYOD Trials Growing in Popularity, But Unique Tech Challenges Remain

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing