NEWS FROM TTC
Check
out the latest industry news and insights into clinical cost
benchmarking as brought to you by GrantPlan�, CRO CostPro�,
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IISiS™ - The Tool That Offers Audit
Protection... Is Your Company Covered?
IISiS™, Investigator Initiated Study integrated System, is the newest tool
that focuses exclusively on the Investigator Initiated Study benchmark
costs. IISiS™ provides a workflow
resource for the application, budget verification and on-line negotiation for
the study investigator and the Pharma/ Biotech company.
But of greater importance, in the
event of an audit, the pharma sponsor will have adequate evidence that payments
made to Health Care Professionals (HCPs) and Health Care Institutions (HCIs)
conducting these studies are consistent with payments based on Fair Market
Value (FMV). Recent Corporate
Integrity Agreements with the Office of the Inspector General (OIG) included in
the scope, payments to HCPs and HCIs doing clinical research on government
reimbursed products.
When your company takes advantage
of the workflow resource and benchmarking capabilities of IISiS™, the
submission, review process and negotiating of an investigator submitted study
is simplified and accurate. IISiS™offers the capability to store proposals and contracts as well as contract
attachments creating a central repository for final negotiations while
retaining logs of conversation between investigator and company.
IISiS™ is your insurance policy
supporting FMV of payments to investigators. It's easy to use and customized to meet your specific needs.
We can demonstrate. Simply contact us at (215) 243-4103, or email us at [email protected].
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Do Sites Prefer A Sponsor Company Or CRO to Run Their Clinical Trials?
CROs conduct a substantial, and growing, percentage of
clinical trials for sponsor companies. Drug development professionals in sponsor companies
have sometimes though voiced concerns about how clinical sites view working
with CROs, particularly as it relates to the consequences of CRA turnover and a
possible lower level of in-depth study compound knowledge. An in-person, mail and web based global study of over 4,000
sites demonstrates that investigators have largely come to accept CRO study
management as an integral part of today's clinical research. More investigators prefer CRO
management (29%) to sponsor company direction (23%). The largest number of investigators though (48%) do
not care whether a CRO or sponsor company runs a study in which the
investigators are participating. The general pattern does not vary appreciably by type of site. For instance the kind of sites,
academic medical center and teaching hospitals, that many might most expect to
prefer sponsor company project management, do not. Only eighteen percent of these investigators prefer sponsor
companies over CROs.
Most (54%) are indifferent between
sponsor company and CRO. The desire
to work directly with sponsor companies is highest in North American (31%). Yet, investigators all of types who do prefer
to work with a sponsor company are not willing to accept even a slightly lower
cost per patient grant to work with these companies rather than CROs. For many investigators CRO
study management is an
accepted fact of their clinical research activities.
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From The Help Desk
June 2010
Budgeting for complex procedures requiring subject care
post procedure or overnight stays are discussed in this issue. The relevant
non-procedure codes vary according to the type of procedure or activity and as
the protocol specifics. From the grants TTC receives in-house, we see a trend
toward increasing numbers of fees for facilities.
For example, in studies involving chemotherapy for
several hours, we often see the simple facility fee used. For those requiring
overnight, a simple overnight fee can be applied. When the procedure is more invasive such as bronchoscopy,
the code for day facility fee complex can be used since there is the potential
for adverse outcomes post anesthesia for this type of procedure. Overnight
facility charge complex is used in cases where the subjects are quite ill and
need to undergo a more serious procedure. Of course in certain cases the
subject will be reimbursed for a protocol requiring an overnight stay.
In cases where the subject lives a distance from the
site hotel fees are used. This occurs more often in countries outside of the
US. Similar fees can be applied when tests are scheduled for later in the day
and again in the early morning but with no need for overnight monitoring of
subject diet or activity.
Please feel free to contact us with any questions you
may have.
Happy budgeting!
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Let Us Know What We Can Do For You!
Contact Us @:
TTC Corporate Headquarters
4548
Market Street
Suite
M-20
Philadelphia,
PA 19139
(215) 243-4103 (Tel)
(215) 895-4001 (Fax)
Chicago Office
816
West Evergreen
Suite
200
Chicago,
IL 60642
(773) 799-9378 (Tel)
(773) 681-7144 (Fax)
TTC European
Headquarters
136
Delaware Road
London,
W9 2LL UK
44 (0)7792 145 831 (Tel)
44 (0)2086 584 033 (Fax)
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