Approach


The Agile approach optimizes every aspect of studies and consistently delivers outstanding results.

Health Decisions offers all the services you expect from a CRO and more, adding value across a wide range of projects and programs. Our Agile Clinical Development methodology optimizes every aspect of clinical studies. The LiveTrial Global CTMS implements the Agile methodology, providing a stream of LiveData to support earlier, better management decisions. Every study benefits from the insights of clinical development experts based on advanced analytics, LiveData and more than 25 years of experience in clinical research. The approach consistently increases efficiency while reducing timelines and risk. LiveTrial Dataflow Chart Updated June 2014

Proactive Trial Management Driven by LiveData

Our study teams don’t wait for periodic reports to find out what’s happening in your study. Instead, they track performance based on streaming LiveData from the LiveTrial CTMS. PMs and CRAs identify issues as they emerge and intervene promptly to keep studies on track and prevent issues from compromising the efficiency of operations or the integrity of results. The proactive Health Decisions trial management approach enables continuous refinement of operations from study start through database lock. View information on Health Decisions’ proactive management.

The Agile Methodology

Health Decisions’ Agile Clinical Development methodology is the most comprehensive in the industry – a unique combination of continuous, comprehensive refinement of trial operations and selective optimization of key parameters such as sample size utilizing adaptive design techniques (when consistent with regulatory requirements and sponsor preferences). Design and operations work in concert. Agile development applies the adaptive concept to operations as well as design, optimizing overall trial management and key operational areas such as monitoring, enrollment and site management. View information on Agile Clinical Development.

Development Insight and Expertise

Health Decisions’ senior professionals draw on deep development expertise and experience to provide insights that improve planning and execution of every Health Decisions study. Health Decisions’ experts advise on overall development strategy, program planning and study design as well as planning individual trials and ensuring optimal trial management and execution. View information on Health Decisions’ development insight and expertise.

The LiveTrial CTMS

Health Decisions’ LiveTrial CTMS puts Agile Clinical Development into action. LiveTrial provides sponsors with a convenient overview summarizing study progress at a glance and enables Project Managers to maintain close management control over each study. Project Managers and monitors utilize advanced dashboards and specialized tools for tracking site performance, assigning tasks, tracking issues to resolution and scheduling monitoring visits based on conditions at each site. Dynamic Key Performance Indicators adjust to the requirements of each study. Health Decisions’ integrated Agile Risk-Based Monitoring+ provides capabilities consistent with regulatory guidance but going far beyond, not only ensuring patient safety and data quality but also providing a leap in efficiency. LiveTrial’s advanced analytics enable decisions that increase efficiency in every aspect of operations. View information on study management with Livetrial.

Read Health Decisions’ insights in the White Paper, Agile Clinical Development: Improving Success Rates, Speed and Efficiency in Clinical Research.