Surprised about the lack of response on this one. Anyone have a good/bad CRO story to share for Julie?

I was vice president of a company doing a clinical trial at a large hospital in Ohio. I hired a CRO and in doing so I felt they did an exceptional job. My problem with the CRO was they found the most expensive hotels to stay at and therefore to contain cost, I had to limited their freedom to choose hotels. I will stop at this point

Hi Julie-

I think it’s the only way to go. Working with a CRO will cost more upfront but can save a fortune in the long-run. CROs run more trials in a month than most of us will participate in during a lifetime and by consequence they’ll think through nuances many of us would have missed. They speed things up, they dot “i’s” and cross “t’s” and have great connections around the world. That doesn’t answer all your bullet points but I hope it helps...

Julie Omohundro Joe, I was surprised too, given that device trials have been such a hot topic in recent years.

Nicholas and Daryl, I appreciate your responding. Perhaps I should have started with Question 0: CRO or no CRO? What I was aiming for was the type of information that might be helpful to companies that had already answered that question in the affirmative, and were now trying to figure out how to choose one that will meet their needs.

Going forward, I think more companies will be needing to collect more clinical data for more devices, so that many companies will be testing these waters for the first time. A CRO is a supplier, so you need to establish selection criteria for them, like any other supplier. It's hard to do that if you have no experience with the type of supplier you are seeking, so hearing about the experience of others can be very helpful.

Mark Plait I've had quite a bit of experience working with and for CRO's. I would advise
against using any university facility that takes public funds as all work done with or through them becomes public accessible and you lose any confidentiality. The smaller the CRO you use, the more you, the sponsor, need to have a strong QA presence. Remember, it is the manufacturer's responsibility to assure that the
CRO's they hire, are performing the study according to protocol and the regulations. I have some war stories I could tell you but "confidentiality" means that on this medium of conversation, I will stay away from talking about it. I can say that some were large labs that seriously under performed.

There are several good specialist/niche CRO's with focus on Medical Device. Factory CRO or QServe, just to name a few examples. Plenty of good information and references available for both of them. Send me a message and I will come back on it.

CRO's can provide great help, especially when you are short staffed, fairly new to clinical trials, and could use an extra pair of eyes on your protocol, need information regarding "powering" your study, and need help with choosing a site and qualifying it. In addition, CRO's will often have templates you can use and probably have initiated a similar study in the past. However, you can spend a lot of money if you are not prepared upfront and know what you want to achieve.-Do as much as you can upfront writing a synopsis and confirm in-house with upper management that t what you want to achieve with your trial. Some CRO's will let you pick and choose their services. I have never worked for a CRO but have utilized CRO's a number of times to strengthen my clinical trials.

Julie Omohundro Rob, thanks for the two examples. I always look first at the management team, and I quite like the look of the Factory CRO team. The name is a little off-putting for me, but I'm thinking it may have evolved from a German word that doesn't translate all that well to English, at least not in this context.

The QServe team seems well qualified, but heavily dominated by former NBers, so I personally would be more inclined to consider them for trials that will support CE Marking, and therefore must conform to ISO 14155.

Julie Omohundro Mark Plait, excellent point. Always read the fine print. Some CROs (and other service providers) have connections to investors. If you are a start-up, this connection may be a plus, but at the very least you want to be sure that, in securing development-related services, you aren't trading any rights away without realizing it. This could also be a condition of some public funding. Also, you want to be sure that this type of service provider is at least as strong on the service to be provided as it is in finding opportunities for its VC connections.

Arjun Sharma CROs can also enhance execution of a global trial (speed site selection, reduce site set up time, and improve enrollment)when the CRO has a foot print in geographies which are new to the device manufacturer.

Julie Omohundro The question of CRO or no CRO is more usefully addressed as CRO or...what? DIY? The answer to this question is different for a large medical device company versus a smaller established manufacturer, versus a start-up.

A large company that has developed in-house clinical research management capabilities can reasonably DIY, but it may also outsource as needed to deal with "peaks and valleys" in its demand for clinical data. The other two types of companies can also DIY, but IMO, not reasonably, at least not when it comes to a pivotal trial.