Indication: Prostate Cancer
Type of Study: Longitudinal observational patient registry
Sponsor: U.S. pharmaceutical company
Patient Population: 10,000
Investigative Sites: 50+
A web-based data collection tool was designed for a national, longitudinal, observational registry of patients with prostate cancer. Demographic, clinical assessment, health care utilization, quality of life, and satisfaction with care data were collected. Individual patient graphs and reports, as well as site specific graphs benchmarking against the entire data set of over 10,000 patients were developed. Patient questionnaires were based on validated instruments such as the UCLA Prostate Cancer Index and the SF-36 survey.
Indication: Breast Cancer
Type of Study: Safety Surveillance
Sponsor: U.S. biotechnology company
Patient Population: 400
Investigative Sites: 400
An on-line EDC solution was developed for a biotechnology company and CRO in support of an observational study of clinical outcomes in patients diagnosed with a breast cancer. Approximately 400 patients will be enrolled at 400 sites located throughout the United States. Data is collected directly from patients and health care providers via electronic patient questionnaires. Patients will be followed for a period of 3 years. Real-time project management and clinical benchmark reports are available on-line and/or in excel exportable functionality to track study progress, data cleanliness and patient outcomes. The solution allows the collection of data during regular study visits, as well as daily dataset availability for statistical analysis. A training website was provided to the sites for the practice of entering dummy data without affecting the integrity of the study database.
Indication: Intestinal Cancer
Type of Study: Safety Surveillance
Sponsor: U.S. biotechnology company
Patient Population: 2000
Investigative Sites: 500
An on-line EDC solution was developed for a biotechnology company and CRO in support of an observational study of clinical outcomes in patients diagnosed with colorectal cancer. Approximately 2,000 patients will be enrolled at 500 sites located throughout the United States. Data was collected directly from patients and health care providers via electronic patient questionnaires. Patients were followed for a period of 2 years. Real-time project management and clinical benchmark reports were provided to track study progress, data cleanliness and patient outcomes. The solution allowed the collection of data during regular study visits and during ad hoc physician office visits, as well as daily dataset availability for statistical analysis. A training website was provided to the sites for the practice of entering dummy data without affecting the integrity of the study database.
Indication: Lymphoma
Type of Study: Longitudinal observational patient registry
Sponsor: U.S. biotechnology company
Patient Population: 5000
Investigative Sites: 500
An on-line EDC solution was developed for a biotechnology company and CRO in support of a longitudinal, observational study of clinical outcomes in patients diagnosed with lymphoma. Approximately 5,000 patients were enrolled at 500 sites located throughout the United States. Data was collected directly from patients and health care providers via electronic patient questionnaires. Patients were followed for a period of 5-10 years. Real-time project management and clinical benchmark reports were available on-line and/or in excel exportable functionality to track study progress, data cleanliness and patient outcomes. The solution allowed data collection during regular study visits, as well as daily dataset availability for statistical analysis. A training website was provided to the sites for the practice of entering dummy data without affecting the integrity of the study database.
Indication: Oncology
Type of Study: Site Enrollment
Sponsor: U.S. biotechnology company
Investigative Sites: 500
A website was created to collect registration information for a biotechnology company supporting two extended access clinical trials from interested physicians. The intent was to assess the demand for patient access to an oncology drug used to treat patients with advances in NSCLC (Non-Small Cell Lung Cancer) and to adequately address the requirements of the program. Approximately 500 sites participated over the course of a 12 month period. A real-time project management report was provided to track study progress. The client had the ability to download data from the website on-demand through an instant data export mechanism. A training website was provided to the sites for the practice of entering dummy data without affecting the integrity of the study database.
Indication: Ovarian Cancer
Type of Study: Chart Review
Sponsor: Biomedical Company
Patient Population: 500
Investigative Sites: 20
ViewPoint FUSE Implementation consultants partnered with a biomedical company and CRO to design a Post-Marketing chart review study to assess the clinical response in patients with primary, recurrent and ascites-positive ovarian cancer. This client had a need to quickly deploy the study to gather national data to analyze the clinical response scores to the in-vitro chemo sensitivity testing. All the data was delivered to the client on-demand using ViewPoint FUSE’s SAS export tool.
Indication: Breast Cancer
Type of Study: Chart Review
Sponsor: U.S. biotechnology company & U.S. healthcare insurance company
Patient Population: 3800
Investigative Sites: 100
Critical objectives for the project: speed to kick-start the project quickly; accuracy to obtain correct data without multiple iterations. The ViewPoint FUSE application went live in six weeks and enabled the Organizer to complete the data collection project for NCQA QI accreditation in three months. The data was automatically checked for errors upon abstractor entry. In addition, medical claims data was incorporated with the final dataset.
