Roles and Modules

The System provides a collaboration framework for all study constituents. Depending on the end-user’s role, access to various features of The System may be restricted to provide only the needed forms and reports. Examples of The System end-use scenarios and related features are detailed in the following areas:

• Project Managers / Directors >>
• Site Managers / CRAs >>
• Data Managers / Owners >>
• Executive Stakeholders >>

Project Managers / Directors

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 Data Lifecycle Plan. The advantage of automating these results 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. Key functionality available to Project Managers includes:

• 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.

CRA/Monitors

CRAs typically track data to be monitored along with site visits using Excel spreadsheets and paper files resulting in individual lists of sites and associated workload. In addition, they must keep and maintain a running list of regulatory document statuses for each site and remember to ensure the documents are up-to-date to ensure compliance with federal regulations. They work with the lack of visibility into the status of patient visits and data readiness at the sites, more often than not they travel to sites only to find the site / data is not “ready” resulting in high costs and low productivity.

Dataflow Manager leverages the knowledge and expectedness of data status to project when monitoring visits will be most productive and provides automated reports for Monitors to bring on-site that list data expected to be monitored according to the schedule and only what’s reported to be present in the system. Furthermore, if configured, these plans may incorporate other data such as images, outstanding queries, and expected or expiring regulatory documents. 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.
• Creation of expected monitoring plans for site visits.
• Directory of site locations and personnel.

Data Managers

Preparation of data from verification through analysis is a critical process and has become more challenging with less control over the data in terms of its cleanliness, accuracy, or timeliness. 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 for preparation to analysis. Various source data are aggregated according to the known study events and the study protocol providing the ability to track data from sources at the subject, visit and observation levels. Changes to these data are logged to provide a comprehensive trail of data modifications which can help determine how and when data operations were performed. 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
• Assess the clinical data status at the subject, visit, and observation levels.
• Determine site performance for query resolution and overall data availability/collection history.
• Review subject registration incorporating eCRF versions, enrollment, screening, and randomization workflows along with the ability to add additional, non-evaluable subject information.

Medical Reviewers/Analysts

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 typically not ready. This has caused a significant delay in moving toward a truly in-stream clinical trials process.

Dataflow Manager incorporates these analysts into the overall study data workflow to verify data validity and readiness for these analyses. Data reviewers are able to browse data from various sources in one central interface, record narratives, and adjudicate findings. Key features available to Medical Reviewers/Analysts include:

• 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.

Executive Stakeholders

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. This ensures that the entire study team is working from the same study status and everyone has a common understanding of study progress leading to rapid and informed decision making. 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.