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Quote from Guest on May 6, 2022, 12:29 amHas the near comprehensive outsourcing of trial management from in-house pharma to the CRO industry saved the world?
The one sponsor I've worked with that still maintains a fleet of in-house CRAs consistently delivers a preposterously better work environment on their projects than their outsourcing peers.
Lots of smart people churning through under-supported roles, duplicative monitoring during turnover, and continual shifts in managers...it is hard to imagine that CROs deliver either a superior or less-expensive work-product.
DCT is best-executed from a well-structured and efficient core. As the sites slog through DCT identity crises, can we recentralize trial management? If not, can we have a peak at the project ledger?
Has the near comprehensive outsourcing of trial management from in-house pharma to the CRO industry saved the world?
The one sponsor I've worked with that still maintains a fleet of in-house CRAs consistently delivers a preposterously better work environment on their projects than their outsourcing peers.
Lots of smart people churning through under-supported roles, duplicative monitoring during turnover, and continual shifts in managers...it is hard to imagine that CROs deliver either a superior or less-expensive work-product.
DCT is best-executed from a well-structured and efficient core. As the sites slog through DCT identity crises, can we recentralize trial management? If not, can we have a peak at the project ledger?
Quote from brad on May 6, 2022, 1:11 amQuote from Guest on May 6, 2022, 12:29 amHas the near comprehensive outsourcing of trial management from in-house pharma to the CRO industry saved the world?
The one sponsor I've worked with that still maintains a fleet of in-house CRAs consistently delivers a preposterously better work environment on their projects than their outsourcing peers.
Lots of smart people churning through under-supported roles, duplicative monitoring during turnover, and continual shifts in managers...it is hard to imagine that CROs deliver either a superior or less-expensive work-product.
DCT is best-executed from a well-structured and efficient core. As the sites slog through DCT identity crises, can we recentralize trial management? If not, can we have a peak at the project ledger?
Yeah I don't see how sponsors aren't throwing their money away by using these shitty CROs. The sponsors that invest and stay in house seem to run their studies so much more smoothly with better attention and care in their site relationships.
Maybe someone smarter than me knows why the CRO is still relied on so heavily even though it's clearly inferior, at least from my small perspective at the site.
Quote from Guest on May 6, 2022, 12:29 amHas the near comprehensive outsourcing of trial management from in-house pharma to the CRO industry saved the world?
The one sponsor I've worked with that still maintains a fleet of in-house CRAs consistently delivers a preposterously better work environment on their projects than their outsourcing peers.
Lots of smart people churning through under-supported roles, duplicative monitoring during turnover, and continual shifts in managers...it is hard to imagine that CROs deliver either a superior or less-expensive work-product.
DCT is best-executed from a well-structured and efficient core. As the sites slog through DCT identity crises, can we recentralize trial management? If not, can we have a peak at the project ledger?
Yeah I don't see how sponsors aren't throwing their money away by using these shitty CROs. The sponsors that invest and stay in house seem to run their studies so much more smoothly with better attention and care in their site relationships.
Maybe someone smarter than me knows why the CRO is still relied on so heavily even though it's clearly inferior, at least from my small perspective at the site.
Quote from Jeanette on May 6, 2022, 4:00 amQuote from brad on May 6, 2022, 1:11 amQuote from Guest on May 6, 2022, 12:29 amHas the near comprehensive outsourcing of trial management from in-house pharma to the CRO industry saved the world?
The one sponsor I've worked with that still maintains a fleet of in-house CRAs consistently delivers a preposterously better work environment on their projects than their outsourcing peers.
Lots of smart people churning through under-supported roles, duplicative monitoring during turnover, and continual shifts in managers...it is hard to imagine that CROs deliver either a superior or less-expensive work-product.
DCT is best-executed from a well-structured and efficient core. As the sites slog through DCT identity crises, can we recentralize trial management? If not, can we have a peak at the project ledger?
Yeah I don't see how sponsors aren't throwing their money away by using these shitty CROs. The sponsors that invest and stay in house seem to run their studies so much more smoothly with better attention and care in their site relationships.
Maybe someone smarter than me knows why the CRO is still relied on so heavily even though it's clearly inferior, at least from my small perspective at the site.
Because, for some reason, complexity is valued over simplicity. If we can get that mindset to change, we might have hope.
Quote from brad on May 6, 2022, 1:11 amQuote from Guest on May 6, 2022, 12:29 amHas the near comprehensive outsourcing of trial management from in-house pharma to the CRO industry saved the world?
The one sponsor I've worked with that still maintains a fleet of in-house CRAs consistently delivers a preposterously better work environment on their projects than their outsourcing peers.
Lots of smart people churning through under-supported roles, duplicative monitoring during turnover, and continual shifts in managers...it is hard to imagine that CROs deliver either a superior or less-expensive work-product.
DCT is best-executed from a well-structured and efficient core. As the sites slog through DCT identity crises, can we recentralize trial management? If not, can we have a peak at the project ledger?
Yeah I don't see how sponsors aren't throwing their money away by using these shitty CROs. The sponsors that invest and stay in house seem to run their studies so much more smoothly with better attention and care in their site relationships.
Maybe someone smarter than me knows why the CRO is still relied on so heavily even though it's clearly inferior, at least from my small perspective at the site.
Because, for some reason, complexity is valued over simplicity. If we can get that mindset to change, we might have hope.
Quote from Guest on May 6, 2022, 9:38 pmI’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.
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.
Quote from brad on May 6, 2022, 9:53 pmQuote from Guest on May 6, 2022, 9:38 pmI’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?
Quote from Guest on May 6, 2022, 9:38 pmI’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?
Quote from Guest on May 6, 2022, 10:09 pmThe overall accountability is still with the sponsor running the trial. What happens is sponsors do a transfer of responsibilities to a CRO and it’s documented on a TORO form and the FDA form 1571. What I have noticed is CROs have such a convoluted, complicated process for stuff to get done it blows my mind. One notorious for this is Syneos. I would rather shit and clap in my hands than work for or with them again. Processes, in my opinion, should follow the KISS method (keep it simple stupid). Processes should be written and conducted in the simplest and fastest manner while still conveying they something needs to be done.
The overall accountability is still with the sponsor running the trial. What happens is sponsors do a transfer of responsibilities to a CRO and it’s documented on a TORO form and the FDA form 1571. What I have noticed is CROs have such a convoluted, complicated process for stuff to get done it blows my mind. One notorious for this is Syneos. I would rather shit and clap in my hands than work for or with them again. Processes, in my opinion, should follow the KISS method (keep it simple stupid). Processes should be written and conducted in the simplest and fastest manner while still conveying they something needs to be done.
Quote from brad on May 6, 2022, 10:37 pmQuote from Guest on May 6, 2022, 10:09 pm. I would rather shit and clap in my hands than work for or with them again. .
I think I love you
Quote from Guest on May 6, 2022, 10:09 pm. I would rather shit and clap in my hands than work for or with them again. .
I think I love you
Quote from Jeanette on May 7, 2022, 12:51 amQuote from Guest on May 6, 2022, 10:09 pmProcesses, in my opinion, should follow the KISS method (keep it simple stupid). Processes should be written and conducted in the simplest and fastest manner while still conveying they something needs to be done.
YES. I have seen mistakes happen because of overly-complicated fluffed-up SOPs. Stop it. Prune the excess.
Quote from Guest on May 6, 2022, 10:09 pmProcesses, in my opinion, should follow the KISS method (keep it simple stupid). Processes should be written and conducted in the simplest and fastest manner while still conveying they something needs to be done.
YES. I have seen mistakes happen because of overly-complicated fluffed-up SOPs. Stop it. Prune the excess.
Quote from brad on May 7, 2022, 1:36 amAny thoughts as to the bloat and overcomplication? Is it CYA, billable time or just incompetence?
Any thoughts as to the bloat and overcomplication? Is it CYA, billable time or just incompetence?
Quote from Guest on May 7, 2022, 2:00 amQuote from brad on May 7, 2022, 1:36 amAny thoughts as to the bloat and overcomplication? Is it CYA, billable time or just incompetence?
It’s control.
So I am working on a project where the CRO has the sponsor add To Be Classified in the metadata field for a document in the trial master file system instead of just having the sponsor classify the document and the document go through the QC workflow. I pointed it out and straight said this is the dumbest process I have ever seen and this is why nothing is being filed. Sponsor agreed with me, CRO is like nah it’s fine. Meanwhile I am pulling my hair out trying to locate documents.
Quote from brad on May 7, 2022, 1:36 amAny thoughts as to the bloat and overcomplication? Is it CYA, billable time or just incompetence?
It’s control.
So I am working on a project where the CRO has the sponsor add To Be Classified in the metadata field for a document in the trial master file system instead of just having the sponsor classify the document and the document go through the QC workflow. I pointed it out and straight said this is the dumbest process I have ever seen and this is why nothing is being filed. Sponsor agreed with me, CRO is like nah it’s fine. Meanwhile I am pulling my hair out trying to locate documents.
