Quote from Guest on May 13, 2022, 11:26 pm

Quote from brad on May 6, 2022, 9:53 pm

Quote from Guest on May 6, 2022, 9:38 pm

I’ve worked at a CRO and a sponsor. There now seems to be a shift to an Functional Service Provider model. Basically a CRO and sponsor contract together and those working under the FSP mode only work on studies with that sponsor. To me that is basically the mode as if everything was in-house.

Now as to why shitty CROs or CROs are still being used in general, in my opinion, it all comes down to money. Various CROs bid for the worn and without a doubt in my mind the sponsor chooses the cheapest bid. This leads to poor quality and I have seen it over and over again. I moved to working life sciences consulting and I can name on CRO that if I NEVER have to work with them again, it would still be too soon.

Yeah I've seen a lot "Syneos dedicated to AbbVie" or whatever. Is this enough to shift the accountability?

Syneos to Abbvie hasn't been to bad. You work with some pretty dedicated and friendly people, although I heard Abbvie may be changing some billing systems that will make it as sub par as the rest of the industry. We ran into a really nasty "dedicated to" relationship between PRA and Gilead - It resulted with some pretty nasty finger pointing with tech liability. When CRO's farm out like this, it turns into an indemnification nightmare as you eluded to. Just be careful of the fine print in the contracts. Most of the time the pharma lawyers will try to ensure sites take all the liability with little say in what happens.

Quote from Mario on May 26, 2022, 9:42 pm

I appreciate this forum to express some ideas. I had some thoughts on this topic,  and I hope you would appreciate a humble opinion from someone working in a big CRO in Mexico (providing services to US/CAN). I completely agree on the SOPs being too many, too complex and often ambiguous because those are made for all the countries with few country-specific SOPs/WIs (and sadly I see more often than not that the people in the CROs see Clinical Research only as a good full time job to pay the bills and everybody is jumping from on CRO to the other for a better salary until they get in any Sponsor). But there are so many huge studies that are running in so many countries with hundreds of sites; for Sponsors with none to little international knowledge I would assume that using a well stablished CRO might be useful(?). As a side note, CROs are still saving so much money on staff by having teams in MEX/ARG/IND or SRB that do exactly the same work as someone in the US with a really bad salary, some TMF entry level position earn around $6.5 per hour and entry level CRAs around $14, if lucky. I hope some humble mexican insights from a former study coordinator (now reg. specialist) are appreciated.