Clinical Trials: Monitors and Research Coordinators

Good Documentation Practices for a Clinical Trial

Source documents are essential documents that are required for Good Clinical Practice. It is the first place...

A Brief History of the Development of Clinical Research Principals, Guidelines, and Regulations

Hippocratic Oath The Hippocratic Oath was likely written between the 5th and 3rd centuries BCE. Its purpose...

5 Aspects of Device Clinical Study Close-Out

A clinical study process that is often underappreciated is close-out. Regardless if the study was completed or...

Selecting the Right Electronic Data Capture (EDC)

What is EDC? EDC stands for electronic data capture. This usually refers to the processes of an...

CRO selection: How to get it right the first time

CRO selection can sometimes be difficult to navigate. “My favorite meeting to have with a CRO is...

Clinical Trial Start-Up Top 5 Challenges

An efficient clinical trial start-up is essential to the success of a multicenter clinical trial. Initiating a...

Modern Tools for Decentralized or Virtual Clinical Trials

Modern Tools for Decentralized or Virtual Clinical Trials Advances in web-based and mobile technologies have led to...

Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives

The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...

Hybrid Clinical Trials in the Age of COVID-19 and Beyond

We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...

Science of Patient Input (SPI): Part 3

Patient input into study design – participation considerations. The last, in a series about the science of...

Science of Patient Input (SPI): Part 2

Last time we discussed how patients’ opinions can shape the design of a clinical study by altering...