Quote from brad on May 19, 2022, 4:00 pm
They are really tricky in how they presented this budget. No line items, just visit totals which totally obscures what's actually happening at each visit.
They don't want to include even 35% OH.
Still won't pay monitor fees and have this to say about it
"BMS does not compensate clinical investigative sites/institutions conducting clinical research in the United States for fees or expenses associated with site monitoring activities, Sponsor audits, or regulatory inspections. As required by FDA and Global Regulatory Agencies, site monitoring and sponsor audits are part of the Sponsor’s obligations, and regulatory inspections are part of the site’s obligations to ensure quality clinical trial data and the protection, welfare and safety of patients. Further, it is the clinical trial investigative site’s responsibility to reasonably accommodate the Sponsor monitor/designee to ensure that BMS is able to comply and adhere to the standards of GCP/ICH, as accepted by the FDA and by BMS."
They have this to say about paying for remote visits:
"Remote monitoring is designed to be less labor intensive than traditional on site monitoring. The costs to monitor are already included in the per patient cost. Therefore, it would be a compliance risk to pay for Remote monitoring or EMR access fees as additional work performed when it is in fact less time consuming than traditional monitoring."
When we asked to be paid for all of the work we do on a screen fail vs a screen fail percentage they say:
"For clarity, BMS cannot cover 100% of screen failures for this study per the study parameters."
They are really tricky in how they presented this budget. No line items, just visit totals which totally obscures what's actually happening at each visit.
They don't want to include even 35% OH.
Still won't pay monitor fees and have this to say about it
"BMS does not compensate clinical investigative sites/institutions conducting clinical research in the United States for fees or expenses associated with site monitoring activities, Sponsor audits, or regulatory inspections. As required by FDA and Global Regulatory Agencies, site monitoring and sponsor audits are part of the Sponsor’s obligations, and regulatory inspections are part of the site’s obligations to ensure quality clinical trial data and the protection, welfare and safety of patients. Further, it is the clinical trial investigative site’s responsibility to reasonably accommodate the Sponsor monitor/designee to ensure that BMS is able to comply and adhere to the standards of GCP/ICH, as accepted by the FDA and by BMS."
They have this to say about paying for remote visits:
"Remote monitoring is designed to be less labor intensive than traditional on site monitoring. The costs to monitor are already included in the per patient cost. Therefore, it would be a compliance risk to pay for Remote monitoring or EMR access fees as additional work performed when it is in fact less time consuming than traditional monitoring."
When we asked to be paid for all of the work we do on a screen fail vs a screen fail percentage they say:
"For clarity, BMS cannot cover 100% of screen failures for this study per the study parameters."
Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
