• 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
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Authors » James Miessler

Articles by James Miessler

searching-skills.gif

CRA Shortage Persists, Innovative Hiring, Training Solutions Needed

February 1, 2023
James Miessler

Industry stakeholders are pessimistic about the state of the CRA workforce and don’t believe progress has been made in combatting shortages, underscoring the need for innovation in how CRAs are trained and evaluated, according to a recent survey.

Read More
2023-loading-text.gif

Decentralization, Site-Enabling Technology and AI in Industry’s Sights in 2023

February 1, 2023
James Miessler
Clinical research has seen marked upheaval in just a few short years as traditional methods were rethought and innovative changes enacted. In 2023, the industry can expect significant progress in the use of artificial intelligence (AI), decentralized and hybrid trials, and site-enabling solutions, as well as further efforts to combat ongoing recruitment and workforce challenges. The CenterWatch Monthly polled a variety of experts on these and other topics. Here’s what they had to say. Read More
Revamp-360x240.png

Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

January 30, 2023
James Miessler
FDA Commissioner Robert Califf has called for major reform of the clinical research enterprise, particularly in how clinical evidence is gathered, to reduce health disparities between scientific advancement and actual U.S. life expectancy, a huge undertaking that some clinical trial experts question. Read More
TimeMoneyEffort-360x240.png

Time is Money and So Is Effort, Budgeting Experts Say

January 23, 2023
James Miessler
Time and effort have their own value and should be budgeted and billed for just as more tangible costs — tests, patient visits, trial supplies, etc. — are, say budgeting and contracting experts who warn sites about letting these intangibles slip through cracks in their systems. Read More
Optimism-360x240.png

Site Optimism for Future Rides High Globally Despite Persistent Challenges

January 9, 2023
James Miessler
Sponsor and CRO acceptance of site input drives site satisfaction, according to a new study that shows sites are three or four times more likely to have a positive view of clinical trials’ future if their sponsors/CROs are open to feedback. But most still have concerns they would like to have addressed. Read More
six-steps.gif

Six Steps to Optimizing SOP Development and Use

January 3, 2023
James Miessler

Standard operating procedures (SOP) are not just necessary for keeping a trial on track, they are mandatory for the FDA and the first documents requested during an inspection. They must be clear, comprehensive and — most important — followed to the letter if a site is to survive close scrutiny. 

Read More
DiversityDark-360x240.png

Site Spotlight: Yale Promotes Diversity in Trials with Cultural Ambassadors

January 2, 2023
James Miessler

Community engagement is a must-have component of virtually any diversity, equity and inclusion (DE&I) program, and one academic research center has pioneered a program that brings its community’s culture into its clinical trials.

Read More
Guidelines-360x240.png

International Group Offers Guidelines for Outcome Reporting in Trial Protocols

December 19, 2022
James Miessler
An international group dedicated to fostering more complete, higher-quality trial protocols has released new guidelines that recommend nine characteristics of effective trial outcome reporting that can be applied to protocols regardless of a trial’s design or population. Read More
DataVisualization-360x240.png

Visualizing Data: Turning Data into Comprehensible, Valuable Insights

December 19, 2022
James Miessler
Identifying and communicating the stories clinical trial data tell is critical to delivering actionable insights, but it’s best to start small when organizing data into easily visualized images. Read More
Enrollment-360x240.png

Enrollment, Staffing Continue Decline, but Sites May See Some Workload Relief in 2023

December 12, 2022
James Miessler
A look back at the clinical trials landscape in 2022 shows that although record high levels of resignations, increasing scarcity of investigators and declining enrollment rates are slated to continue into 2023, the rate of trial starts appears to be stabilizing somewhat, giving sites a chance to possibly catch their breath in the new year. Read More
Previous 1 2 3 4 5 6 7 8 9 … 16 17 Next

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

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

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

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 or Share My Data

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing