ProSanos' Observational Study Services
ProSanos offers a full range of observational study services designed to evaluate and demonstrate the impact of healthcare products. Specific study types include:

• Observational Registries (prospective or retrospective)
• Phase IV Mandated Studies
• Patient Chart Review Studies
• Patient Reported Outcomes and Quality of Life Studies
• Pharmacoeconomic Analysis of a Product

ProSanos prides itself on offering high quality clinical operations with concurrent strategic planning to maximize the visibility and the impact of the knowledge gained from the study. ProSanos has the ability and expertise to manage all aspects of a clinical project - from design, inception, and site recruitment to the dissemination of knowledge gained from the analysis of the data.

ProSanos provides a full range of observational study services, including:

Study Design and Development

• Tactical and strategic clinical project planning
• Project design and objectives
• Advisory Board creation and management
• Protocol development
• Case Report Form development (paper or electronic)
• Global or local clinical projects

Study Operations

• Recruitment for project participation (investigator, patient)
• Management of Ethics or Institutional Review Board Approval
• Oversight of Regulatory documentation and reporting requirements
• Initiation and training for all project participants
• Site/patient communications and monitoring

Study Data Management

• Data query generation, resolution, and management
• Online reporting
• Interval summary reports
• Regulatory agency data reporting
• Data integration

Study Analysis and Reporting

• Statistical analysis planning at project start
• Interim analysis regularly throughout project
• Outcomes analysis
• Data interpretation
• Publications planning
• Medical writing
• Dissemination of knowledge gained

Data Capture and Online Reporting
ProSanos' Accument^® is a secure, integrated web-based study portal optimized for the unique environment of observational studies and registries. It enables real-time understanding and sharing of data, making it possible for clinical investigators and sponsors to have access to critical information in a timely manner. More than just a simple Electronic Data Capture (EDC) platform, Accument features the following:

• Online data capture (available globally)
• Online data management capabilities including query generation and resolution
• Project communication and collaboration capabilities (e.g., educational materials, news bulletins, and project-specific newsletters)
• Workflow support
• 21 CFR 11 compliant
• Available for participants to log in and enter or view data 24 hours a day without need for special software or equipment
• Real-Time data viewing and sharing
• Integration of other data sets (trials or studies)
• Automatic reporting for project management

Since Accument^® was developed specifically for ProSanos and we have complete ownership of the technology used in our clinical projects, we can offer cost-effective customization and support that others cannot match.