Managing Studies

It is typical in the management of clinical trials that Project Managers manually update project plans to chart the expected time lines and milestones of their study, only to find that determining the status of the study against the plan is difficult and prone to inaccuracy. The traditional manual methods require hours of meetings, conference calls, and at best manually produced status reports from individuals to collate and in many cases guess the trial status.

Dataflow Manager is designed to optimize this process by automating the retrieval of study milestones, site statues and data progress into the configured Study Plan. Key information contained in the study protocol and associated study plans are configured into Dataflow Manager’s Study Plan.  This is what Dataflow Manager uses to automate the tracking and reporting of operational information. From the study plan, Dataflow Manager begins extrapolating metrics, predicting milestone achievements using analytics, and guiding users through the global study workflow.

The advantage of automating these processes is not limited to reducing the time Project Managers need to put into producing reports, but also ensures the most up-to-date reporting as possible. 

Users can:

• Evaluate the status of the trial against expected time lines and configured milestones.
• Review interactive dashboards to ensure the study is on plan and on schedule
• Links from the plan into related data used to compute the selected metric or milestone.

Managing Sites

Data begins at the investigator sites. As such, Dataflow Manager begins tracking site information before a patient is even enrolled. From site initiation through lock, the system is automatically tracking site progress, data availability, and expected dataflow based on dynamic site performance metrics.

Dataflow Manager leverages the knowledge and expectedness of data status to project when monitoring visits will be most productive and provides an automated report for Monitors to bring on-site which lists data expected to be monitored according to the schedule and only what’s reported to be present in the system. 

Key features available to Site Managers include:

• Evaluation of sites in terms of patient visit schedules, readiness of data for monitoring, as well as the status of the regulatory documents. 
• Review details of data expected to be monitored, late and missing data, outstanding queries, and recent site activity.
• Automation of regulatory document expectation based on site progress, and ability to upload and review all regulatory documentation centrally on-line.

Managing Data

Preparation of data from verification through analysis is a critical process and has become more challenging. With data coming in from many difference electronic sources, Data Managers are forced to access/use multiple systems or electronic data files sent by individual vendors.   Each of these systems/vendors has its own workflow and data status that may conflict or misalign with the other.  This presents a significant problem in that the Data Manager cannot easily ascertain the overall status of the trial data across systems/vendors.

Dataflow Manager provides a central interface for evaluation of disparate data and enables holistic preparation of data for analysis. 

Key features available to Data Managers include:

• Tracking clinical dataflow against expected schedules, not just from the sites, but from the labs, imaging centers, and IVR systems
• Determine site performance for query resolution and overall data availability/collection history.
• Review subject tracking, incorporating eCRF versions, enrollment, screening, and randomization workflows along with the ability to add additional, non-evaluable subject information.

Managing Subjects

Medical Reviewers or Analysts are often challenged with gaining access to data required to analyze as well as having confidence in its validity for analysis.  As a result, the Analysts are extracting data at random times through vendors or reports without knowing the overall status of the data, only to find the data is not ready.  This has caused a significant delay in moving toward a truly in-stream clinical trials process.

Dataflow Manager automatically delivers subject profiles with study disposition information, adverse events, evaluation scores and other eligibility criteria for study arms and data analysis.  Data reviewers are able to browse these integrated subject profiles in one place, record narratives, and adjudicate findings. 

Users can:

• Determine data readiness for analysis based upon automated study algorithms
• Review Patient profiles to evaluate key endpoints and/or critical values for analysis.
• Perform review activities for subjects with data ready for analysis to indicate that the review is in-progress or completed.

Managing Results

The executive stakeholders are responsible for the overall success of the trial.  This requires a very proactive role in managing the trial to success including budget, strategy, and results. Executive stakeholders are often at the mercy of the waiting game – waiting for the project managers to deliver the status of the trial time lines, and hoping the statisticians have the data they need to analyze the trial trends and provide some insight as to the viability of the product.  Unfortunately, given the current challenges facing the project managers and the statisticians, the executive stakeholders receive outdated status and results based upon incomplete or inaccurate data.  Of course, without accurate information the executives cannot make time critical decisions to bring their product to market.  This can result in the best case, a loss of time and expenditures on unnecessary cycles of work, and in the worst case, the loss of critical trial data and the study as a whole.

Dataflow Manager leverages the information about data workflow for the study to provide up to date metrics on study progress without needing to request reports from managers.  . 

Key features related to Executive Stakeholders include:

• Viewing the status of the trial through an interactive dashboard, providing current study status and trending on trial data to simply deliver the information needed.
• Leveraging integrated analytics to predict the operational performance of the trial.
• Centralizing study reports for easy access against a common data source.

Managing Sources

Dataflow Manager uses web services to facilitate data retrieval from distributed eClinical systems. Over the last few years, several of the leading clinical technology vendors have developed and made available commercial web services APIs for their products, and PharmaPros has developed a library of ready-to-use adapters for these technologies, enabling on-demand integration capabilities.

For those technologies where an API is not available, including technologies within a customer enterprise, PharmaPros deploys its Enterprise Adapter, a universal web-services adapter to enable real-time data integration with any system.  The system uses automated data loading for any type of data from sources that are not web-accessible. Integrating data has never been so easy. Just click a button, and it happens automatically.

Users can

• Schedule source integrations at any time interval
• Click a button for on-demand integration
• Upload data directly into the system
• Refresh data as often as needed