Pharmaceutical Post Marketing Surveillance Study

Challenge
Solution
Results

Challenge

A division of a global pharmaceutical company wanted to obtain real world data on the use of its product in the market place for clinical studies and market share analysis as newer competitive products were being launched. The company did not have the resources to technically develop or manage such a project and operating it themselves would have proven to be costly and time consuming. In addition, because the participating medical facilities were already burdened with data entry responsibilities, recruitment was going to be a challenging task.

Solution

Tii was chosen by this company to design, implement, recruit, manage and support this registry. During the analysis phase of development, Tii worked in tandem with the sponsor physician, research analysts, global marketing staff and clinical coordinators from participating centers to make sure the registry accomplished all of the goals of the stakeholders.

Specifically, Tii

  • Helped develop the study protocol
  • Created an effective site and patient recruitment and retention process
  • Managed the IRB process
  • Developed an adverse event reporting protocol
  • Developed site training programs
  • Provided full site remuneration services
  • Developed all legal agreements
  • Developed participant registry software, documentation, training materials and Web site
  • Managed the central database
  • Distributed confidential electronic quarterly reports to the company that enables them to analyze registry participation and trends
  • Maintained and hosted the registry Web site
  • Provided research data to the company that can be presented to the medical community
  • Provided customer and marketing support
  • Insured the confidentiality of facility and patient data

Results

The registry developed by Tii provides a centralized, efficient, consistent means for collecting and analyzing data. By better understanding how the drug is being used in a real world setting our client is better able to evaluate the drugs therapeutic value and thus improve practices and ultimately save lives.

  • Participation: Over 80 facilities now participate with over 1800 patients enrolled: As a result of this success the operation of this registry has been extended for another two years.
  • Benchmark Data: Comparative data on adverse events can help validate the success of certain therapies- or suggest a need to improve.
  • Adverse Event Reporting: Pharmacovigalence is automatically alerted when an adverse event gets reported into the registry.
  • Research Data: This registry provides outcomes data for researchers to assess the effect of changes on therapy protocols.
  • Hard Dollar Savings: Tii was able to put this registry into production in under five months. The sponsor company saved time and money relative to developing its own data collection and reporting system. Our expertise and understanding of the therapeutic market helped the recruitment effort and established this registry as a vital part of this company's product, clinical and research strategy.