RxTrials Communiqué - A Blog About Clinical Research

Standard Operating Procedures Table of Contents

As discussed during our initial blog about SOP’s, (click here to view initial blog) sites could benefit from a list of SOPs needed by any reputable site. Thank you to all those that contributed to creating this list. While I am sure many people will have suggestions to improve upon this list it is my hope you will share those ideas with us here.

So here is to a happy cross verification between what you already have in place and where you go next.

Click here to view the SOP's Table of Contents

 

Clinical Trial Site Startup Activities

A common concern among research sites is that of capturing all of their startup costs for a trial.  Estimates of these costs can range from $5,000 - $15,000 and most sites with which we associate are not reporting that sponsors are paying these sums.  more...

Face It: Face-to-Face Meetings May Be a Thing of the Past

RxTrials welcomes Donna J. Percy, RN, BSN, as guest blogger who wrote the below post. Donna is vice president of Research at Sterling Research Group in Cincinnati, Ohio. 

If fewer and fewer of your Investigator and Site Initiation Meetings are happening face-to-face, welcome to the new world order, where it appears that technology may trump tradition. more...

Speak up on SOPs

SOPs - Standard Operating Procedures - have a place in our business. Love ‘em or hate ‘em, they help to ensure quality and consistency in our performance and protect study volunteers. You may consider some SOPs more critical than others and some even unnecessary. Maybe, like me, you think there's no clear-cut set of SOPs established for clinical research sites.  more...

What’s In a Name? Does it Really Matter if You Deliver Results?

Over the years, the title of the clinical research site or collections of sites has evolved, like everything in our industry. Twenty years ago, when research was almost exclusively conducted in academic facilities and teaching hospitals, it was pretty easy. Fast forward to 2010 and an array of titles:  more...

Who's Driving the Study Selection Process?

Would you agree to buy a car without knowing the cost and, worse yet, without enough information to know whether you can afford the terms of the car loan? The idea of doing something like that surely must sound ludicrous to you. Yet a scenario much like this occurs every day in the clinical study selection process involving sites and their business partners.  Let's review how this process typically happens now. more...

Paydays in a New Decade: Meaningful Change or More of the Same?

Let's start this decade with a resolution and a solution: To improve the financial health of clinical research sites through our commitment to negotiate (demand?) monthly payments for services rendered.

It's a reasonable request in the business world, right? But it's not happening in the clinical research site business. Here's why and here's why it has to change. more...

FDA Issues Guidance for Clinical Research Investigators

Protecting the rights, safety and welfare of study subjects is the number one priority when conducting clinical research.

The FDA recently released (in October 2009) a "Guidance for Industry" paper which provides Clinical Research Investigators guidance on their responsibilities in protecting the rights, safety and welfare of study subjects. This guidance paper contains numerous expectations and clarity of how Investigators should be managing and conducting their clinical research.  more...