Managing clinical trials for the biotech and pharmaceutical industries requires a high degree of coordination and compliance. Smaller contract research organizations (CROs) typically struggle with a dizzying volume of spreadsheets, emails, and documents to keep trials moving forward and clients up to date. At Atlantic Research Group, however, a Clinical Trials Management System (CTMS) built entirely with Quickbase has enabled the company to meet a high standard of efficiency, compliance, and service to its clients.
- Spreadsheets and Microsoft Word documents limit efficiency for tracking clinical trials
- Reporting progress to clients manually required lengthy data collection and email process
- Standard clinical trial management software too expensive and inflexible for smaller firms
- Clinical Trial Management System (CTMS) built with Quickbase
- Clinical Research Associates (CRAs) enter data directly into Quickbase for review
- Project managers work from a single source of truth on multiple long term clinical trials
- Clients have self-service access to limited reports to keep on top of trial progress
- Easy customization allows ARG to build unique solutions for each customer, quickly with no coding required
- No redundant data entry
- Automated notifications keep project teams moving forward
- Self-service reporting means happier clients
Atlantic Research Group (ARG) launched in 2004 with a mission to serve innovators in the biotech and pharmaceutical industries. Founders Paul Bishop and Lyle Camblos had worked for large contract research organizations (CROs) and knew they could better serve the smaller biotech and pharma companies that drive the most exciting research.
As the company grew (it currently employs 35 people), the limitations of managing trials with spreadsheets and Microsoft Word documents became readily apparent. Spreadsheets were limited to one user at a time, and managing appropriate access to them was nearly impossible. And multiple revisions of Word documents sent by email bogged down key processes.
Larger CROs typically use dedicated Clinical Trial Management Systems (CTMS), but those solutions are typically expensive and difficult to customize — not a good fit for smaller organizations.
In 2006, ARG hired Hunter Walker to come up with a better way. Walker had previous experience with Quickbase, and saw the benefits of building a flexible, scalable solution in the cloud with no coding required. In just two weeks, he built the beginnings of the clinical trial management solution the company still relies on today.
Managing Complex Projects
Clinical trials typically last for 1–2 years, and CROs are responsible for not only recruiting doctors and patients, but also ensuring that all data collected during the trials is clean and accurate. Early on, ARG managed trials with standard office productivity tools. Project managers updated spreadsheets and clinical research associates (CRAs) submitted trial data by emailing Microsoft Word documents for review.
That changed with the launch of TrialVista, ARG’s trial management solution powered by Quickbase. Now, project managers keep tabs on project progress via the cloud-based app, and automated notifications ensure that key activities are assigned at the right time. CRAs conduct interviews from doctors’ offices and hospitals and enter the data directly into a Quickbase form from any web-enabled device. That data is then reviewed by another team, and changes can be requested and completed within the app itself. This saves critical time that was once wasted with email attachments and constant revisions.
CRA schedules are also managed from Quickbase, so ARG knows which doctors they are scheduled to visit and when.
Because compliance is also critical, ARG licensed a tool called QB Documentor from Quickbase Solution Provider Juiced Technologies. The tool captures and provides documentation on app-related data, including which users made changes to fields and when. Having these reports on hand is key to managing compliance audits.
Because TrialVista is cloud-based, ARG is able to share information with its clients in ways it could not before. After building out a customized trial management app for a client, ARG can specify a user role that gives the client read-only access to key data, such as project timelines. In this way ARG assures that trial data remains secure but clients have self-service capability to get the information they need. Overall, Walker says, the results of running and managing clinical trials in Quickbase have been overwhelmingly positive.
The Partner Perspective
To help meet its standards for compliance, Atlantic Research Group uses a tool called QB Documentor from Juiced Technologies. The tool logs key data about application usage and automatically generates PDF reports ARG can use to satisfy auditors.
Keith Jusas of Juiced Technologies, a Quickbase Solution Provider (QSP), says QB Documentor is perfect for any industry in which tracking access and modifications to a Quickbase app is part of compliance standards.
How It Works
Customers who use the QB Documentor tool get a separate Quickbase app that ties into key data in the app they want to document. From inside the app, customers can drill down into the tables, fields, and reports in their app, and view modification logs that track all changes to any of those.
To track these changes, QB Documentor runs a periodic scan of the app to identify changes — typically on a weekly or monthly basis, though some customers have run the process daily. These scans typically occur in the early morning hours when few people are using the system.
Each scan automatically generates summary reports that are stored as PDF files in the QB Documentor app for easy access.
The app also generates diagrams that help administrators keep track of all the relationships between tables and fields, including custom diagrams based on the customer’s needs. Each diagram is stored automatically as a PDF so customers don’t need to re-run the diagramming process frequently.
The result, says Jusas, is an add-on tool that saves time, eliminates tedious manual efforts, and satisfies audit requirements.
For more information on QB Documentor and other Juiced Technologies tools, visit the Juiced Technologies partner page.