Projects

The following are brief descriptions of some of the solutions that TII staff have deployed. Regardless of size or stage of your project TII can provide a wide range of services that help you reach your clinical, research or business objectives.

ISHLT:

International Registry for Heart and Lung Transplantation

http://www.ishlt.org

This voluntary registry, sponsored by the International Society of Heart and Lung Transplantation (ISHLT), was created for the purpose of providing on-going, current information on the worldwide thoracic organ transplantation experience. This Registry is the only one of its kind and every country performing a minimum specified level of heart, heart/lung and lung transplantation is invited to submit data to the Registry. As of today the database contains data contributed from 36 countries. The collected data is made available to ISHLT members and the public via online quarterly data reports and annual data slides prepared by TII biostatisticians. Additionally, members may submit queries to the Registry and obtain specific data sets or data analyses needed for a research project or manuscript.

Specific technical requirements included a scalable, flexible architecture that allows international transplant centers to submit data directly to the database using Electronic Data Capture (EDC) as well as international Organ Exchange Organizations (OEOs) to submit data via an annual data transfer. OEOs act as transplant data collection points for some countries and through an agreement with the ISHLT are able to contribute data on behalf of the individual centers. TII development staff designed, developed, tested and deployed this system and provides ongoing support to the ISHLT. TII clinical operations staff enrolls individual centers and provide training to new users. TII SAS programmers provide data management services to ensure data integrity before the data is finally included in the data set. They also fulfill member data requests and slide preparation for the annual report.

Global Transplant Pharmaceutical Company:

Post Market Surveillance Study

The Registry was developed so that its sponsor could collect and analyze clinical data on transplant patients taking an immunosuppressive drug after receiving a Kidney transplant. Immunosuppressive drugs are needed to prevent organ rejection. The goal is twofold: to optimize Immunosuppression treatment strategies and to collect important safety data and adverse event information in a secure confidential environment. The system was deployed in 2003 and now has data on over 3,000 patients contributed by more than thirty transplant centers.

TII, in collaboration with the sponsor’s clinical, research and marketing staff, designed, developed, tested and hosts the database system. Our clinical operations staff provides technical support to the sponsor and participating centers. In addition, they provide ongoing site recruitment, patient enrollment, center remuneration, and training. This system also allows the sponsor to meet its regulatory requirements by incorporating an adverse event (AE) reporting system whereby the sponsor’s Pharmacovigalence team can track adverse events experienced by patients taking the immunosuppressive and report these to the FDA. Analysis from the data collected has been presented at numerous U.S. and international transplantation conferences.

The National Living Donor Assistance Center (NLDAC)

http://www.livingdonorassistance.org

In October 2007 the University of Michigan, in collaboration with the American Society of Transplant Surgeons (ASTS) and TII, launched the U.S. Health and Human Services (HHS) sponsored National Living Donor Assistance Center (NLDAC), a nationwide system that provides reimbursement of travel and subsistence expenses to living donors. A primary objective of the program is to increase access to organ transplantation by low income individuals. The costs of being a donor can represent a substantial financial burden on the parties involved; for some, non-reimbursed expenses may make living donations impossible. TII was hired by the ASTS to design, develop, host and provide technical support for the system. The Division of Transplantation (DoT), Health Resources and Services Administration (HRSA) anticipate providing $8 million over four years to provide reimbursement to eligible donors.

National Insurance Association:

Secure Bariatric Center of Excellence RFI Portal

This portal was developed so that confidential information about the association's Bariatric Surgery Centers of Excellence could be electronically submitted via a secure portal by plan members (medical institutions performing Bariatric bypass surgeries) and analyzed by the association's auditors. Prior to the system launch, plan members were required to fill out multiple surveys, sometimes twenty or more pages each, manually. This process took months to complete by multiple hospital personnel and because of tight deadlines for submission many programs could not complete the survey in time and missed the certification window. This cost them an opportunity to be designated a Center of Excellence which meant possible loss of revenue and business. Once these surveys were completed association and staff had to manually score each answer and calculate a rating that either qualified or disqualified a center from being eligible. Letters then had to be mailed to each program explaining why they did not qualify.

TII developed a web based survey and scoring system that automated all of these functions for both association members and staff thus shortening the RFI cycle time. This resulted in a satisfied member base, an increase in approved centers and cost savings to the association.

Berlin Heart, Inc:

IDE pre approval clinical registry

In May of 2007 Berlin Heart was granted Conditional IDE Approval by the FDA to begin a multi-center study in the U.S. of the EXCOR® Pediatric, a pediatric ventricular assist device. Because of regulatory requirements and FDA guidelines related to web based data collection processes for clinical studies and the significant effort that this entails Berlin Heart chose TII for the development and operation of this study.

TII project management and programming staff worked in conjunction with Berlin Heart and their CRO to assess the project requirements, designed the framework, developed the infrastructure, tested and deployed the secure web based application. TII clinical operations staff provides ongoing sponsor and site support, enrolls new sites and provides periodic updates and reports to Berlin Heart.