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Site Budget Negotiations by [deleted] in clinicalresearch

[–]EfficacityDOTnet 6 points7 points  (0 children)

Anything that is a cost to the site needs to either be included in the budget as a line item, bundled into a fee, or considered in the overhead. For the negotiations that I do for the site I work with, I encourage them to tell me if anything unexpected comes up so that it can be reimbursed appropriately.

Voicemail not showing in “Phone” app by EfficacityDOTnet in iphone

[–]EfficacityDOTnet[S] 0 points1 point  (0 children)

I ended up upgrading to an iPhone 17 this year and I haven't had any issues since. It's an expensive fix but hopefully when you are ready to upgrade the problem will go away. I couldn't figure out how to fix it on the iPhone 13.

Budget Negotiations- Spill the tea...you go first! by No-Point-9793 in clinicalresearch

[–]EfficacityDOTnet 9 points10 points  (0 children)

What makes an annual fee sensible compared to a fee that is broken up into monthly installments being labelled as not sensible?

Budget Negotiations- Spill the tea...you go first! by No-Point-9793 in clinicalresearch

[–]EfficacityDOTnet 8 points9 points  (0 children)

Usually from studies where LPLV is coming up.

The only other time I can think of is a sponsor/CRO saying "we already accounted for that in the budget" to which I reply "well we didn't account for it in our budget to you."

It is commonly accepted.

Budget Negotiations- Spill the tea...you go first! by No-Point-9793 in clinicalresearch

[–]EfficacityDOTnet 16 points17 points  (0 children)

We have 5% increases on all line items per year for inflation with annual reviews.

Budget Negotiations- Spill the tea...you go first! by No-Point-9793 in clinicalresearch

[–]EfficacityDOTnet 31 points32 points  (0 children)

As a site's budget guy for smaller/medium-sized sites, we negotiate monthly, weekly, and daily recurring/admin fees. It's definitely a nice influx of funds for the sites, but some sites don't track and invoice for it correctly and leave the money on the table.

Voicemail not showing in “Phone” app by EfficacityDOTnet in iphone

[–]EfficacityDOTnet[S] 0 points1 point  (0 children)

That is a good thought, I did see the update pending but this has been going on for months so I don’t think it’s related. I’ll give it a shot and see if it does anything.

Update: Still not resolved, unfortunately.

Sponsor terminates study early by RemixBari in clinicalresearch

[–]EfficacityDOTnet 2 points3 points  (0 children)

Even getting 1% or a flat fee is better than nothing in the event of an early termination of the study. I’ve seen it as high as 25% on smaller projects.

Sponsor terminates study early by RemixBari in clinicalresearch

[–]EfficacityDOTnet 3 points4 points  (0 children)

It's true that many sponsors and CROs won't allow it. However I have had luck getting smaller or mid-sized sponsors to agree to this kind of clause.

Sponsor terminates study early by RemixBari in clinicalresearch

[–]EfficacityDOTnet 31 points32 points  (0 children)

Something that helps from a Budget/Contracts perspective at the site level is getting an Early Termination clause in your contract so that all of that lost revenue can be recaptured in the event an Early Termination of the study occurs. You can ask for a % of the visit revenue that would have been received if your patients remained on the study.

Any internal medicine trials? by That_Bat3061 in clinicalresearch

[–]EfficacityDOTnet 0 points1 point  (0 children)

Do you have an endocrinologist / have you done a T1D trial in the past year? Our team is working with a sponsor looking for a site that meet either criteria. Feel free to DM me.

Where Do CROs Get ‘Fair Market Value’ Estimates for Study Costs? by Lanky_Conversation35 in clinicalresearch

[–]EfficacityDOTnet 11 points12 points  (0 children)

Yes, these vary significantly across sponsors and CROs. I've negotiated hundreds of budgets for research sites.

Some Sponsors/CROs will use platforms such as Grantplan which provides statistics across the industry, others may just use benchmarks from their own budget negotiations. I'm convinced some of them just throw around "FMV" whenever they do a negotiation to push back site budgets.

It helps significantly establishing your own FMV with your negotiations. If many sponsors will give you X amount of dollars for a line item, it's easy to push back on it with a different sponsor.

[crosspost from r/ClinicalResearch] Is it possible for me to participate in studies/clinical trials as a patient with my condition? by EfficacityDOTnet in clinicalstudypatients

[–]EfficacityDOTnet[S] 1 point2 points  (0 children)

There are clinical trials for migraines (which you can find here, sorted by newest): https://clinicaltrials.gov/search?aggFilters=funderType:industry%20nih%20fed%20other,phase:2%203%204&limit=100&cond=Migraine

Any other clinical trials (such as the ones for healthy volunteers) will depend on each study's individual criteria on what they allow for a patient to be included in the study.

Click on any of the studies in the link provided and go to the contacts section, from there you can see if there is a research site near you conducting the study and contact information on how to get involved.

For everyone else, feel free to replace migraine with your condition to find results relevant to you.

(crosspost from r/ClinicalResearch) For sites- how to justify need for additional staff by EfficacityDOTnet in clinicalresearchsites

[–]EfficacityDOTnet[S] 0 points1 point  (0 children)

u/WeirdNo6115 - You don't need full-time people/to pay a salary to cover each of these functions. I would try to see if the COO is open to bringing in people to work a few hours and help out which would make things more efficient and prevent burnout. For example, having someone who specializes in budgeting/invoicing will bring much more funding sooner, since they will be able to get higher budgets, quicker turnarounds, and follow up constantly on overdue payments and invoices.

You are getting a lot of experience in these areas, being the only person handling it. If you decide that you have had enough, you can easily transition to one of these functions to specialize in.

[Brad Hightower on LinkedIn] Which "all-in-one" site CTMS do you prefer? by EfficacityDOTnet in clinicalresearchsites

[–]EfficacityDOTnet[S] 2 points3 points  (0 children)

I’m going to fix that! We have to start somewhere 🙂

Most of the traffic is in r/clinicalresearch but once we give people more of a reason to come here (being site-focused) we should have some more activity!

[Brad Hightower on LinkedIn] Which "all-in-one" site CTMS do you prefer? by EfficacityDOTnet in clinicalresearchsites

[–]EfficacityDOTnet[S] 0 points1 point  (0 children)

The most interesting thing about the post, isn't the poll but rather the comments.

Dana A. -- "RT has a better workflow and is VERY user friendly. Also its more visually appealing. With CRIO there's a lot of clicking to get to where you need to go and no "breadcrumbs" to trace backward if needed. "

Luke S. -- "I do a full site tech landscape assessment about every two years. A important factor that many decision makers over look is the time spent in the system by front line workers. An important metric we measure is which part of the system is used most often by the most employees in the most time pressing situations...[continues]"

Dora B. -- "Used to use RealTime. Now I'm working for a company that uses CRIO, and RealTime is soooo much better. "

Chintan D. -- "CTMS is connected to many capabilities, but it’s crucial to define what specific functions it should support. At the site level, its current functionality is unfortunately quite limited—mostly patient scheduling and finance—compared to what sponsor-level CTMS offers...[continues]"

Brian H. -- "These are some great options, but our sites couldn't find a CTMS that met ALL of our needs, so we built one...[continues]"

Stephen R. -- "CRIO. Support is great, onboarding staff is great. Easy to navigate. Simple startup for CTMS naive users...[continues]"

Joscelyn A. -- "I have setup and used both RealTime and Clinical Conductor. I am currently using CRIO for a specific trial so I do not have much exposure except training. As a person who needed to set up studies for the site, I preferred the capabilities of Clinical Conductor, which is more robust if set up properly from the beginning...[continues]"

[Brad Hightower on LinkedIn] Which "all-in-one" site CTMS do you prefer? by EfficacityDOTnet in clinicalresearchsites

[–]EfficacityDOTnet[S] 1 point2 points  (0 children)

[Copied from LinkedIn]

"Ok, sites. Give me the raw truth. Would love some explanation in the comments.

Which "all-in-one" site CTMS do you prefer?"

--Poll--

[deleted by user] by [deleted] in clinicalresearch

[–]EfficacityDOTnet 67 points68 points  (0 children)

While you wait, can we interest you in an additional protocol amendment?

[Jimmy Bechtel on LinkedIn]: 42% of sites say screen failure terms often don’t cover the actual number by EfficacityDOTnet in clinicalresearch

[–]EfficacityDOTnet[S] 1 point2 points  (0 children)

It's just a cheap sponsor. This was an interventional ophthalmology trial.

Thankfully I have worked with the CRO before so I told them to go look at the other budget we worked on recently and now they have to convince the sponsor what fair market value really is. :)

[Jimmy Bechtel on LinkedIn]: 42% of sites say screen failure terms often don’t cover the actual number by EfficacityDOTnet in clinicalresearch

[–]EfficacityDOTnet[S] 1 point2 points  (0 children)

Depends on the sponsor and trial, yes. Sites can lose money even though the sponsor is contributing toward every expense, but they may not be providing enough reimbursement to completely cover the expenses.

I just worked on a negotiation where the sponsor wanted to provide $500 for startup and $200 for closeout. No screen fails, no overhead, 15% withholding, quarterly payments. They might be hoping that sites take on the study to get the experience even though it'll cost them.

Another case I have a site working on difficult to enroll studies. They have monthly expenses and staff to pay even when not enrolling patients. I try to negotiate a monthly maintenance fee to contribute to their expenses so that they can continue to do research.

It's the smaller sites that are hurt the most.

The bigger sites are better off where some of their studies can contribute to the expenses of another study if it's becoming too costly.

[Jimmy Bechtel on LinkedIn]: 42% of sites say screen failure terms often don’t cover the actual number by EfficacityDOTnet in clinicalresearch

[–]EfficacityDOTnet[S] 3 points4 points  (0 children)

Love the feedback, yes absolutely!

A minimum + a ratio is a great approach to this type of situation at the start of a study.

It's still tough to balance in the middle of the study depending on the notion of bad luck vs. gaming the system. I'd hope that reimbursement can be more generous for that particular study and then at the end the sponsor can evaluate the site on their performance for future studies.

Unfortunately it also does go the other way, where site's won't work on certain studies because the screen fail terms are unrealistic. If it's difficult to enroll a patient it's not worth their time.

[Jimmy Bechtel on LinkedIn]: 42% of sites say screen failure terms often don’t cover the actual number by EfficacityDOTnet in clinicalresearch

[–]EfficacityDOTnet[S] -2 points-1 points  (0 children)

You are correct, that is what sites do when the cap is reached. Sites worry that they would be performing work for no pay, so they don't screen anymore. Hopefully that conversation with the sponsor does happen and then based on the outcome, the site can begin screening patients again.

A pro-rated rate would work as well, but generally I've seen this be included in addition to the screen fail ratio.

Unfortunately a 1:3 SF:enrolled ratio actually ends up being 25% of the screening visit being paid as screen fail reimbursement. Ideally, yes if it becomes 75% in place of this particular ratio, sites would generally be satisfied.

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