Clinical Trial Case Studies

Clinical Trial Case Study # 1: Compressed Timeline

• Scenario: A pivotal NDA trial using 60 sites, 592 patients and a timeline of less than 4 months for the clinical study.

The client was in danger of missing its deadline because of a protracted RFP process in choosing a CRO.

Our international field, data accession, and consultant team solicited sites in South Africa. The team enrolled and evaluated the required number of patients in 12 weeks. The data were transmitted in real time to Saratoga Springs, New York, where the database was closed within two weeks. This information was provided to our West Coast consulting group who completed the final clinical study report ahead of schedule.

• What If: The deadline for this product was critical. Had the client missed the submission date, the sponsor would have had to make a decision whether to continue developing the product.
  
• Results: Criterium saved one month and met the client’s deadline for FDA submission.

Clinical Trial Case Study #2: Reduced Cost

• Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug- The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.
  
  Criterium offered an integrated technology-enhanced solution that allowed the sites to register patients and allowed the patients to record their event data directly into our remote systems.
  
  Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.
  
• What If: If the client had used traditional methods, the cost would have soared for a product that has modest revenue and the data would have taken much longer to provide to the FDA and the prescribing community.
  
• Results: Criterium’s centralized real-time data accession utilizing Automated Fax Scanning (FAX) and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were provided to the medical community and were satisfactory for rapid submission to the FDA for conditional approval.

Clinical Trial Case Study #3: Exceptional Results

• Scenario: Criterium provided an IVR patient diary solution to collect the pivotal efficacy data for an international clinical trial.
  
  Because the estimated patient compliance rate was critical for the statistical analysis, Criterium daily monitored the patient diaries.
  
  Through StudyControl™, Criterium designed reports to evaluate the compliance of each patient during the study. When patient compliance was less than predicted, Criterium informed the client immediately. This critical intervention enabled the sponsor to enroll additional patients into the study. Additionally, the compliance rate increased for those additional patients who were enrolled.
  
  
• What If: An after-the-fact paper patient diary could have been disastrous and could have necessitated the client repeating the study.
  
• Results: The statistical analysis exceeded the client’s expectations.