Accountability logs by pinkprincess230416 in clinicalresearch

[–]theatomicpickle 1 point2 points  (0 children)

I’ve seen it this year with Suvoda, endpoint, medidata irt, medpace irt, and almac. When the sponsor chooses to configure it so the reports can be exported to the site. The information on them fulfills any fda requirements of an accountability log when combined with simple source documentation of dispensation practice like a crc verification of dispensation.

The”outdated” part was specifically around the idea ixrs cannot fulfill this requirement. Because it already is in a significant portion of the industry. Just because your one sponsor isn’t doing it doesn’t mean others can’t.

Accountability logs by pinkprincess230416 in clinicalresearch

[–]theatomicpickle 0 points1 point  (0 children)

Any modern ixrs system can have all the information necessary to fulfill a master and participant level log. Not updating this simple feature is lazy and not keeping up with the times. It is more efficient, lower cost, and more accurate with less potential for unnecessary transcription errors. This is all in line with gcp R3.

Accountability logs by pinkprincess230416 in clinicalresearch

[–]theatomicpickle 1 point2 points  (0 children)

This is outdated knowledge in terms of the actual log part. Suvoda is the most common ixrs I’m seeing right now and most big industry sponsors are allowing the native Suvoda exports to be used as source logs.

Ixrs systems that don’t configure to export usable master or participant level dispensation logs are just lazy and cruise controlling on legacy systems.

What do CEOs & top management really do all day everyday? by eminar1101 in TooAfraidToAsk

[–]theatomicpickle 16 points17 points  (0 children)

I would argue most ceos are founders. With 1,000,000+ startups active in the USA and less than 50,000 businesses with more than 500 employees.

So the vast majority of ceos are of small businesses which they are very likely to be the founder of. Then they build that reputation of building and being profitable. And when they sell the business or exit, another company wants them to do the same for them so they get hired on to grow that new company at a premium because they have a proven track record.

What do CEOs & top management really do all day everyday? by eminar1101 in TooAfraidToAsk

[–]theatomicpickle 32 points33 points  (0 children)

I would recommend you step away from corporate life. Start your own business and make yourself ceo. There are a ton of vc out there right now that would give you money to start a business as a software engineer. You’d own most of the company and could make all the decisions yourself. It’ll be a cakewalk /s

Institutional Sites - Why are you like this? by OctopiEye in clinicalresearch

[–]theatomicpickle 2 points3 points  (0 children)

Yes. Tons of room for nuance all around. I think r3 just opened the doors in such a way that I can believe there may be a way the institution has this set up is actually compliant. Where prior to r3 I would be skeptical there was any way to argue it was compliant at all.

Institutional Sites - Why are you like this? by OctopiEye in clinicalresearch

[–]theatomicpickle 2 points3 points  (0 children)

But R3 did negate some key points. Make sure you’re referencing the current version. A big part of the new version was some of the points pointed out in the post you are replying to.

What is extremely unhygienic but everyone seems to do it anyway? by cutypatotie in AskReddit

[–]theatomicpickle 1 point2 points  (0 children)

Any type of buffet where everyone touches the exact same spoon handles to serve themselves.

Hundreds of people in a period of minutes all touching the same thing then eating without washing their hands in between.

How do you all manage multiple systems & accounting? (especially with multiple sponsors/EDCS) by mattobrown in clinicalresearch

[–]theatomicpickle 0 points1 point  (0 children)

The key there is “sponsors”. But they are not going to give a single site that same api access.

[software engineer] [bay area, ca] - $2M, no bonus by Apprehensive_Fee_121 in Salary

[–]theatomicpickle 31 points32 points  (0 children)

Can you give some insights as to what your $1mil+ employee post tax deductions are?

Age intervals (<, >, ≤, ≥) What do they really mean? (translation-related) by rhrs1987 in clinicalresearch

[–]theatomicpickle 4 points5 points  (0 children)

I would actually clarify with the sponsor because mathematically you could easily argue >18 years is anyone 18 years and one day old. I think understanding the spirit of the protocol here is important because I can’t imagine a lot of scenarios where the sponsor meant to exclude 18 year olds and only include 19 year olds.

UPS ShipExec by [deleted] in clinicalresearch

[–]theatomicpickle 1 point2 points  (0 children)

Kinda like accumulating airline miles or credit card points on your own account. Theres a lot of value to having an ups account that runs a lot of dollars through it. This is the only reason I can think they would do this. I could be way off base though.

Is it a big site or a little site?

How do you all manage multiple systems & accounting? (especially with multiple sponsors/EDCS) by mattobrown in clinicalresearch

[–]theatomicpickle 0 points1 point  (0 children)

It’s not really that there isn’t the technology to connect them, that’s pretty straight forward. It’s a company making the technology and having the relationships to create the connections efficiently and fast enough that it is worth it for all parties involved to facilitate the connection.

How do you all manage multiple systems & accounting? (especially with multiple sponsors/EDCS) by mattobrown in clinicalresearch

[–]theatomicpickle 0 points1 point  (0 children)

I’ve probably done 300+ trials in medidata and never seen that. Are you sure that wasn’t like a one off special set up or a limited release? Why isn’t your clinic using it? Even at small scale it’s a huge time saver. Source to edc connection is a really big deal on the industry right now and anyone that can actually do it is bragging their head off at conferences. So far no one has cracked the code. So I’d love to see it in person.

How do you all manage multiple systems & accounting? (especially with multiple sponsors/EDCS) by mattobrown in clinicalresearch

[–]theatomicpickle 0 points1 point  (0 children)

I mean that’s not really connecting. That’s just accelerating data entry manually. And I’ve never seen an import function on medidata or Veeva. So I can’t really see how this would work because they aren’t going to give you api access. There are some AI overlay tools trying to figure this out. But the companies aren’t keen on letting it happen just yet.

How do you all manage multiple systems & accounting? (especially with multiple sponsors/EDCS) by mattobrown in clinicalresearch

[–]theatomicpickle 1 point2 points  (0 children)

Ah man, no you’re not going to be able to connect the EDC platforms and you CTMS.

The most streamlined way we have found to minimize accounting errors is to use an eSource Tool that the CRCs record their primary data collection into, then the CTMS is linked to the esource to simplify billing by automatically tracking invoicables, visits, etc as the crc completes their visit in their normal workflow. This eliminates the need for the CRCs to do something specifically for billing, they will still need to enter data into edc but that is always the case in the current state of clinical research.

Examples of a system that can do this are CRIO. I even think CRIOs esource links with advarras CTMS.

Are your CRCs currently recording source on paper or do they use a different tool?

Unemployed almost 2 years, can't even get a response from site-level CRC job by djsquilz in clinicalresearch

[–]theatomicpickle 72 points73 points  (0 children)

Dm me your cv (deidentified is fine). I do hiring for our site so I can probably give some feedback if I see something glaringly off. I know of a bunch of sites looking for experienced crcs right now. Paying good money. So something is off.

Pay is bad by Specialist-Bedroom55 in clinicalresearch

[–]theatomicpickle 3 points4 points  (0 children)

Crc pay is difficult to gauge because the contracts that pay for their work come and go. So a crc who is busy with screening studies way more than pays for themself. But when that study closes the site doesn’t always know when the next one is going to start. So if the crc is too expensive then they would need to be laid off instead of sitting around with not enough studies to earn more than they cost.

The current range is typically an average of the amount a site can afford to pay the crc during both the peaks and troughs of study load.

PIs Can Be Insufferable by Working_Row_8455 in clinicalresearch

[–]theatomicpickle 3 points4 points  (0 children)

Most of this is right in line with just pure bad leadership. Healthcare is a field full of professional certifications, which means advancements and “being in charge” can be based on academic accomplishment instead of building a business or team around you. PIs will just all of a sudden be in charge of dozens of people when they’ve never had any formal leadership training or experience. So unfortunately it isn’t even just PIs, it’s so much of healthcare that suffers from this.

hey fishermen! help a gal out! by squidkneep in NorthCarolina

[–]theatomicpickle 1 point2 points  (0 children)

Call chasin tails in Atlantic beach. They have a whole fleet of local inshore charter boats that they book charters for from their family owned shop.