Problem Solvers

IHC "SWAT" Visits

Are you experiencing...

• Site problems?
• Slow enrolling sites?
• CRF data which is slow getting entered, reviewed and cleaned?
• Sites which are slow getting activated or implementing Protocol Amendments?
• Study Coordinators and Monitors who are slow in resolving problems?

If so, find out how IHC can help resolve these leading issues and save your trial.

Among the myriad of Site and CRO problems, these issues are in the forefront of the critical problems that tend to derail a site and sometimes an entire clinical program.

"SWAT" is a term we use to describe how our clinical and data experts are brought in to quickly resolve these serious problems and restore your confidence in the study.

Below are two typical examples of our SWAT successes. How we succeeded is straight forward. It involves intense work using expert, experienced and specialized monitors and data managers. For those sites that have enrollment problems, our Senior CRAs are trained to involve the investigators and study coordinators in an "In Service" program to make other departments aware of the study, and to get the entire research center focused on identifying prospective patients. Constant awareness is the key to success. The IHC SWAT Team will push hard to invigorate the sites, and work with the clinical centers to get more staff involved in 'funneling' patients to the investigators and study coordinators. Although you can't force a site to aggressively enroll patients, you can motivate the researchers, and give them each a personal reason to see the study succeed.

We work with an array of objectives, incentives and coordinator accountability tasks to ensure your study's success. Each site gets quickly assessed, special objectives and goals laid out and a program implemented that meets the sponsor's needs. A great deal of time, effort and funds are spent to activate a clinical site; so the right effort and the right people can transform a site from a low enroller with problem data to an important contributor with clean reproducible clinical results. These are the measured goals of our expert SWAT Team.

In the dawn of Electronic Data Capture (EDC), it is critical to understand the significant difference in managing studies that collect data differently. Electronic Data Capture studies must be site-managed and clinically reviewed in a totally different manner than paper-based CRF studies. It is also important to have the right monitor, with the right specialized clinical experience and technological knowledge to review and clean your study data. Our team has a great deal of experience and success in trials using this type of data capture.

IHC is Ready

We are ready to help at a moments notice, with the experienced staff that you need. We will present to you, for review and approval, the CV's of the experts we propose to handle your problems - immediately, efficiently and effectively. So don't put your budget and time lines in jeopardy. Consider us your emergency response "SWAT" team.

Call IHC and put our team to work for you.

CASE STUDIES Case Study 1 A clinical study of over 200 centers and 6600 patients were being poorly site-managed. Electronic Data Capture was the means of managing all aspects of the clinical data (date entry, review by the monitors, and cleaning of the data by the study coordinators and data managers). Eighteen (18) sites with over 30% of the enrollment were very behind in entering and cleaning the data for over 1000 patients. This problem had been growing for over 9 months with no real movement resolving the issues. IHC was called in to meet the sponsor's deadline of delivering a clean database of all patients within 4 months. The sponsor company needed to present results of this trial at a late breaking session of the AHA annual meeting. The IHC "SWAT" Team was brought in - we corrected the site problems, had all the clinical data entered, reviewed and cleaned with 2 weeks to spare. This data was presented and very well received at the annual American Heart Association annual conference. Without this effort, a major marketing opportunity would have been lost. Case Study 2 A 200 patient pilot program using paper-based CRFs was over a year behind with enrollment and severely lacking CRF data entry. IHC was brought in to monitor the program and provide separate "SWAT" support at sites where needed. The trial completed enrollment within 6 months after IHC was hired and data was cleaned and submitted by our "SWAT" Team ahead of the sponsor revised time lines. An interim analysis conducted by the sponsor, before IHC was hired, predicted a 40% loss of quality data, due to site and data management problems. IHC was able to reduce that loss data to under 20%. Many data management and data cleaning issues were resolved and the study results were used as part of the pivotal submission of clinical support for the drug's new indication of use.