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June/2010

NEWS FROM TTC

Check out the latest industry news and insights into clinical cost benchmarking as brought to you by GrantPlan�, CRO CostPro�, IISiS™ and Standard of Care™.

       CRO CostPro�

                

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].
 

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.

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!
 
Issue: 2


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In This Issue
IISiS - Audit Protection
Global Site Preferences
From The Help Desk


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TTC, headquartered in Philadelphia and founded by Dr. Harold Glass, offers the largest current database of investigator budgets from 60 countries. With over 100 clients who conduct over 75% of the clinical trials around the world, TTC stands ready to serve all companies with specific programs tailored to meet their customized requirements.