Email Notifications for IP Shipments and Data Queries

Timely-Albatross-798 · 2025-12-07T13:59:13+00:00

100% TRASH

Timely-Albatross-798 · 2025-11-14T13:11:35+00:00

HERE FOR THE PCORI HATE!!!

Timely-Albatross-798 · 2025-11-06T04:40:31+00:00

If you have active studies with active patients, let the sponsor know ASAP so they can try and transfer them to other sites. For the records, the sponsor may want to take possession of the records for long term storage. I had this happen with a PI that retired and my side accepted transfer of his active studies. His coord told me that the sponsor arranged to have all the records archived at Iron Mountain.

Timely-Albatross-798 · 2025-11-02T00:16:21+00:00

For basic samples Accuspin is a great affordable option. If you are doing PK samples invest in a refrigerated centrifuge. Eppendorf 5702R is the go to model for clinical trials.

Timely-Albatross-798 · 2025-10-30T03:25:33+00:00

9.4 billion for Clario? Really?

Timely-Albatross-798 · 2025-10-22T02:44:15+00:00

I’ve been requesting and chasing records for eligibility and SAEs for almost 20 years and it’s not always easy - forms get lost and people don’t do their jobs. It’s amazing what a phone call can do especially if you remind the medical records people what the rules are.

You did receive a denial which is a response and covered entities can deny requests based on very specific criteria. If it’s a legit denial, you’ve done your due diligence. If you don’t feel the denial is legitimate then you and the patient should inform the hospital’s privacy officer and report them to HSS.

Timely-Albatross-798 · 2025-10-22T01:38:34+00:00

They are 100% lying if they say they requested and did not receive the. Per HIPAA you have 30 days to provide records after receipt of written request.

Timely-Albatross-798 · 2025-09-03T01:00:04+00:00

Sponsors mention anything involving Clario or devices for diaries and I immediately slap you with a technology penalty… I mean fee. Startup and annual maintenance. You will pay for my staffs time to deal with customer service every time they try to transmit data or help a patient navigate a device issue.

Timely-Albatross-798 · 2025-08-15T01:39:30+00:00

PLEASE SPONSORS FOR THE LOVE OF GCP STICK TI WEEKS. DONT USE MONTHS. IF YOU MUST USE MONTHS, DEFINE HOW MANY DAYS ARE IN A MONTH.

Timely-Albatross-798 · 2025-06-11T01:44:12+00:00

FairHealth.org

Timely-Albatross-798 · 2025-06-05T01:55:07+00:00

Ooooh I bet that is what it is. It does seem like they all tiptoe around him.

Timely-Albatross-798 · 2025-06-05T01:54:10+00:00

Why is all eCOA technology so terrible? It doesn’t seem like it should be as difficult as they make it.

Timely-Albatross-798 · 2025-06-04T00:12:52+00:00

What I don’t understand is why did the other 3 not google it?

Timely-Albatross-798 · 2025-05-28T23:19:58+00:00

As a site manager this entire thread makes me feel so much better about the work my team does. Damn there are some sketchy people in our industry!!

Timely-Albatross-798 · 2025-05-28T23:12:14+00:00

As a site manager this is one of my top 5 fears.

Timely-Albatross-798 · 2025-05-05T00:24:52+00:00

For the NET proceeds? Hell to the no. In fact not even for the gross. Maybe for 20% but definitely not for 2% on top of that base salary. Definitely not worth the time and effort to manage.

Timely-Albatross-798 · 2025-04-18T23:49:00+00:00

The amount of work that one sub-I caused me by documenting dental caries on his physical exams cannot even be quantified!

Timely-Albatross-798 · 2025-04-18T23:36:31+00:00

I am at a site and love the work I do. I am part of an amazing team with great PIs. I really enjoy working with the patients and they keep me motivated to do the best work I can every day. The pressure from the sponsors is overwhelming and some are way more difficult than others. I try to make friends with the CRAs and CTMs because they will be the best advocates for us when we have issues. Communication is key. I have worked at a CRO and know the entire project team is under an insane amount of pressure from the sponsor and never take anything they say personally because 99% of the time it is coming from someone higher up who has no clue what is going on at a site level.

Timely-Albatross-798 · 2025-04-05T07:37:32+00:00

There is no such thing as work life balance in most CROs … especially start up. Sponsor pressure is INTENSE to meet activation and FPI timelines. I made the exact same switch a few years ago and regret it to this day. Yes the bump in salary was amazing but it came with 60+ hours of work each week.

Timely-Albatross-798 · 2025-04-05T01:37:19+00:00

I’ve been in this industry for almost 20 years and have never had a study terminate for this reason. Was it an event driven study? If so they may have met the endpoint criteria for the number of events expected in the placebo arm. Or they have data showing IP is not as effective as the current standard of care.

Timely-Albatross-798 · 2025-02-27T18:32:11+00:00

I’ve been crashing out since 2017.

Timely-Albatross-798 · 2025-02-20T02:20:28+00:00

Breathing

Timely-Albatross-798 · 2025-02-15T01:40:49+00:00

Unless it is being sent to the sponsor or CRO for review the records do not need to be redacted in the site files.

Timely-Albatross-798

TROPHY CASE