Case Study: Therapeutically Focused Clinical Services Firm Leverages RegDocs365™ for Reduced Training Timeline and Expanded Functionality

SUMMARY

When this Contract Research Organization (CRO) first started using RegDocs365™ to manage their clinical trial data due to the clinical trial sponsor’s requirements, they quickly observed that the platform offered significantly more benefits than other systems they had utilized in the past. While other systems were too bulky and difficult to navigate and meet organizational needs, this single source repository’s easy-to-use nature substantially reduced training time while offering expanded functionality. This standardized data and documentation platform ensures its users are able to easily learn the system with minimal training and RegDocs365 can be customized to fit a trial’s unique needs for ultimate functionality.

Today, this CRO continues to recommend the RegDocs365 solution to clients who are not currently utilizing a document management system.

THE CLIENT

A leading therapeutically focused Contract Research Organization that offers comprehensive clinical research organization services such as project management and clinical data monitoring for studies at any stage, Phase I – IV. This company provides flexible and comprehensive support, allowing them to reach their goals effectively and efficiently while acting as an extension of their sponsor clientele.

THE CHALLENGE

The main challenge this CRO faced was trifold. They struggled in finding a single, unified repository solution that was easy-to-learn, offered a wide variety of functions, and met all of their clients’ needs to standardize their processes. While the company had worked with a few different types of systems, they had found that many were too big and bulky to meet their specific needs, and also required hours of labor-intensive, internal training before they could properly utilize them. And, oddly enough, while many of these systems were too large to fit their company’s needs, they still lacked essential functionality and flexibility across a variety of trial requirements.

THE SOLUTION

After coming across the RegDocs365 system thanks to a client project, this organization found Court Square Group’s repository solution to be a simple, easy-to-use option with limited training requirements and unlimited potential for expanded functionality as new needs came about.

Together, the company and Court Square Group worked together to add in additional functions as demands and needs changed for their clients’ clinical trials, including:

• Intuitive reporting functions to easily view site-readiness reports
• Comprehensive and customizable dashboards to see where files are originating from, their current status, and the number of files remaining at any given time
• Auto-classification capabilities for received documentation to automatically categorize and file information without the need for manual action

THE RESULTS

Because the RegDocs365 platform is adaptable to be as simple or complex as the client requires, it offers a single, unified solution across a variety of clinical trials, and still standardizes the process for sponsors of all shapes and sizes. For this organization who works with more than 20 different clients on 30 to 40 different trials within the same timeframe, this solution significantly decreased training timelines and restraints. Once an employee has been trained on the RegDocs365 platform, they can utilize it for all of their customers’ trials without needing to learn a variety of new, different systems for each situation. Average training time per employee is just two days.

This benefit, paired with the enhanced functionality that Court Square Group offers based on industry feedback makes RegDocs365 one of the most robust solutions available on the market.

SEE FOR YOURSELF

If you’re ready to cut back on your company’s training hours and unify your business’s clinical trial data and documentation in a single repository, contact Court Square Group to see how our team can help you get started with RegDocs365.

ABOUT COURT SQUARE GROUP

Court Square Group is a leading managed services technology company dedicated to empowering those who change lives. Our Audit Ready, Compliant Cloud™ (ARCC) infrastructure provides Life Science companies with the highest level of data integrity from pre-clinical to clinical and regulatory approval through manufacturing. We manage the 21 CFR Part 11 validated infrastructure so you can focus on secure Clinical Collaboration & Content Management.

 

ABOUT RegDocs365™

RegDocs365™ is a fully 21 CFR Part 11 compliant, ready-to-use, cost-efficient content and document management solution hosted in an Audit Ready Compliant Cloud (ARCC) validated environment. As a turn-key content management solution built specifically for Life Science companies, RegDocs365 supports life science companies actively bringing drugs, biologics, or devices to market in their efforts to prepare regulatory submissions.   RegDocs365 provides a Life Science focused platform for all of your workflow, dashboard and document management needs in a fully regulatory compliant fashion.