Comprehensive GAS products and services to enhance your study protocols.

Seamless Implementation, Rigorous Evidence

Ardea Outcomes has pioneered standardized approaches for seamless integration of  Goal Attainment Scaling (GAS) into study protocols. Our team of GAS experts provides study design advisory and personally onboards trial sites, providing comprehensive training for clinicians and raters in the art and science of GAS implementation. Coupled with GoalNav®, our electronic data capture platform, clinicians walk through a straightforward protocol for goal-setting and follow-up, supported along the journey by our team.

GoalNav® Training: Ensuring Successful Implementation

Clinician training is central to a successful GAS implementation, assuring data integrity and reducing bias. In our model, sites are taken through a comprehensive onboarding where CRAs and GAS raters complete a multi-module bespoke online training course prior to goal-setting with participants. This ensures that the healthcare professionals are able to set SMART (Specific, Measurable, Achievable, Relevant, Time-bound) goals that capture the symptoms and challenges most meaningful to the patient. Our comprehensive five-module GAS  training covers the following:

  • Introduction and overview of goal attainment scaling
  • Detailed practical scenarios and specific examples
  • Comprehension quizzes and self-assessment tools
  • Study-specific module outlining all details relevant to GAS implementation as outlined in the protocol

Goal Inventory Development

Ardea Outcomes is a pioneer in the development and use of Goal Inventories for GAS training and implementation. Working in collaboration with sponsors, patients, and clinician experts, we use qualitative research to outline the most common and meaningful goal areas in a particular disease area. Using a qualitative research approach, we conduct in-depth interviews with patients and their caregivers and facilitate focus groups with clinician experts to gain profound insights into individuals' daily hurdles and priorities. Goal inventories can be further adapted and refined with iterative research or by sponsors to ensure that they reflect the potential impact of the therapeutic intervention being tested. Through in-depth interviews with patients and their caregivers and facilitated focus groups with clinician experts, we gain profound insights into individuals' daily hurdles and priorities in coping with these health issues.

Goal inventories increase the feasibility of GAS implementation, orient the patients and their families to the GAS process, and may result in a wider variety of goals being set.

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GoalNav® Software: Streamlining GAS Data Collection

Built with the user in mind, the GoalNav® electronic data capture platform walks the clinician through the GAS data collection process to identify, scale, and rank goals.

  • Highly Configurable
    GoalNav® can be configured to any study protocol, including hybrid and fully decentralized trials. Fields are customizable, and additional outcomes and surveys can be included.
  • FDA CFR Part 11 and EU Annex 11 Compliant
    GoalNav® facilitates compliance with FDA CFR Part 11 and EU Annex 11 required for electronic source data capture in clinical trials through e-signatures, access control, versioning, and audit records.
  • Supports Data Monitoring and Quality Assurance
    Data monitoring is enabled through query creation, follow-up, and resolution workflows. The Ardea Outcomes support team can review goals using our quality assurance process and provide timely feedback and additional training to sites.
  • myGoalNav® Patient Portal
    Patients can log in remotely to track goals in hybrid trials or decentralized real world evidence studies.
See GoalNav in Action

With 30 years of foundational experience in Goal Attainment Scaling, we are the leading experts in using GAS as a personalized endpoint in clinical development. Our extensive expertise allows us to enhance your drug development programs to align with the latest patient-centered paradigms.