How to Choose a Good Clinical Research Organization (CRO)

Member

By Sarah Wilson CCRP
User-Submitted Article

Article Rating:

(4 Ratings)

Choose a Good Clinical Research Organization (CRO)

Over the years, several groups have formed to help sponsors and investigators with clinical trials. These groups include Site Management Organizations (SMO), Clinical Trial Management Organizations (CTMO) and Clinical Research Organizations (CRO). The CRO, to date, is the only body discussed in the regulations and given legal authority to act on behalf of a person conducting a clinical trial. A CRO can legally represent the sponsor. The SMO and CTMO are not specifically covered in the regulations and are not given authority by the regulations to act on a clinical investigator's behalf. However, investigators have the right to delegate clinical trial tasks to qualified individuals - hence they could hire a SMO or CTMO to assist them. There are several CROs available and if you ask any Clinical Research Coordinator familiar with working with CRO's, there are usually ups and downs. I will tell you how to flip that down to up status and lower your stress level at the same time.

Difficulty: Moderately Easy

Instructions

Things You'll Need:

Clinical Research Knowledge

Step 1

What Should You Look For When Choosing a CRO?

There are several things a sponsor should consider when choosing a CRO. The first thing you want to look at is how long have they been in business? Are they a start up company? Now, don't let that put you off automatically because everybody has to start somewhere. You just need to decide if you want them to start with YOU. Consider the Phase of your clinical trial (i.e. Phase I, II, III, or IV). Phase I and II are less risky if you want to deal with a start-up CRO. How dependent are you on this clinical trial? Is this your only investigational product or do you have several? If the CRO runs a bad clinical trial, will it just set you back a pretty penny or will it use up all your resources and cause your company to belly up? Consider all of these when dealing with a new CRO. If the CRO has been around for awhile, ask for references and then check them out.
Step 2

Can the CRO provide qualified and adequate resources to oversee your clinical trial?

Even if the CRO has been around for awhile, many of them are notorious for a high employee turnover rate. Therefore, you will want to see the training record and qualifications of the employees who will be managing, monitoring and overseeing your clinical study. Goggle the names and see if any disciplinary action shows up. Now, some CROs will show you the "bio" without the employee’s names because they can't compete with pharmaceutical companies in the salary range. To keep from losing good personnel, they tend to redact names. Since you might not see any names before a commitment to do business is made, ensure your contract includes a statement that the CRO run background checks on employees and can testify that no debarment action by the government exist. This is important because hiring people who were debarred by the Food and Drug Administration (FDA) could mean all your data gets tossed out and that will be money wasted. The FDA is very clear that they may not choose to accept any submitted data that was obtained by debarred individuals.
Step 3

Turnover rate - high, low, average?

Is the CEO the only long-term employee in the company? Well, we know the CEO is probably not going anywhere, so we want to focus on the "workers". The laborers are the people who will either make your clinical trial or break your bank. Do they have documentation of Good Clinical Practice training? Are there any Clinical Research Associates with experience in the therapeutic are under investigation? If not, how will the CRO provide you with adequately trained CRAs?
Step 4

Will the CRO Sub-contract Your Work?

It is not unusual for a CRO to sub-contract some of the work, especially clinical trial monitoring. If this is the case, ensure the CRO have a good training program in place for sub-contractors as well their own employees.
Step 5

Can You Really Get Qualified Investigators for my Clinical Trial?

Again, you want to base the selection of the clinical investigators on a few things. However, the most important of all is that they be "qualified by training and experience in the indication under investigation". I have seen podiatrist and family doctors as clinical investigators on atherosclerosis clinical trials. Some sponsors/CRO believes that as long as they are a "doctor", they qualify. This is not true. They should have experience in atherosclerosis. The right FDA Inspector would make a serious issue out of that.
Step 6

Bottom Line.....

The bottom line is that there are a lot of areas to cover when choosing a CRO. So, simplify the process. Go to www.wqats.com/Auditing.html and outsource it.