Recommended Reading

5 Problems With Using Spreadsheets to Collect Clinical Data

5 Problems With Using Spreadsheets to Collect Clinical Data

Spreadsheets are too basic of a tool to keep up with the increasing complexity of clinical trials. Here are 5 reasons to stop using them.

Read more »

Subject Reimbursement in Clinical Trials:  When and How?

Subject Reimbursement in Clinical Trials: When and How?

Trial participants often complete things that likely would not be requested with routine care. When and how to compensation subjects is often debated.

Read more »

Latest Posts

An Easier Go-Live: 4 Questions to Ask Before Implementing Your CTMS

Discuss these questions with your CTMS vendor to speed up the implementation process and increase the effectiveness of your new system.

Read more »

Coverage Analysis Quiz - Does Your Knowledge Stand the Test?

Coverage Analysis is an important tool for maintaining clinical research billing compliance. Take this quiz to find out if you’re prepared for your next billing initiative.

Read more »

Therapeutic Forecasting: Areas to Consider in 2016 – Q&A

Following his recent webinar on therapeutic forecasting, Riley Kammer of ClinEdge, answers attendee questions about competitive markets, feasibility questionnaires and more.

Read more »

The Beginner’s Guide to an Electronic Data Capture (EDC) System

This post walks you through the basics of an electronic data capture system, providing a high-level overview of benefits and common functionality.

Read more »

How to Motivate and Retain Study Coordinators – Q&A

Mallory Thomas of ClinEdge, explains the benefits of “stay interviews” and provides tips for motivating clinical research site employees.

Read more »

Featured Series: Compliance and Regulatory

About the series

Clinical research regulations have an important purpose–to ensure best practices are followed and to increase patient safety during the clinical trial process. However, even well-experienced clinical research professionals struggle to decipher the numerous regulations associated with conducting clinical trials. This series provides resources and advice to help you interpret the complexities of regulatory challenges such as billing compliance, FDA audits, HIPAA and more.

  1. Assessing Common Challenges in Clinical Research Billing Audits

    Ryan Meade, of Aegis Compliance & Ethics Center, LLP, discusses top challenges associated with conducting clinical research billing audits.

    Read more »

  2. Aiding Clinical Research Compliance With SOPs – Part I

    (Part 1 of 2) In response to her recent webinar, Sherri Bracy of Bracy Consulting, LLC, answers questions surrounding compliance and Standard Operating Procedures.

    Read more »

  3. Reference Guide - Popular FDA Regulations in Clinical Research

    Stop searching and use this help sheet to find the most referenced regulatory time requirements for Investigators and Sponsors of medical device research.

    Read more »

  4. HIPAA Basics for Clinical Research Q&A

    Following her recent webinar, Marilyn Windschiegl of PFS Clinical answers questions regarding HIPAA compliance in clinical research.

    Read more »

  5. Do SOPs for Data Collection Equal Compliance with 21 CFR Part 11?

    Anders Lindquist clears up common confusion surrounding standard operating procedures and 21 CFR Part 11.

    Read more »

  6. Preparing for an FDA Audit? Learn How.

    While FDA audits are fairly common, many researchers haven’t been through them yet. Learn what it takes to be prepared for your next audit.

    Read more »

  7. Creating a Culture of Research Compliance Through Prevention

    Beverly Ginsburg-Cooper of the Huron Consulting Group explains how a preventive approach can promote compliance throughout an organization.

    Read more »

Write for us!

Are you interested in writing about a topic in clinical research?

We'd love to have you become a guest contributor for the Forte Clinical Research Blog.

Learn more