Court Square Group
Delivering Quality and Compliant Clinical Documentation Services

Pharmaceutical and biotech companies require robust systems that can streamline data management, clinical trial management and regulatory submissions. This is especially challenging for early stage companies that do not yet have the staff in place to develop the standard operating procedures (SOPs), information technology (IT) infrastructure and software customizations necessary to meet regulatory requirements such as the FDA’s 21 CFR Part 11. These challenges are magnified because many pharma and research organizations are largely reliant on cumbersome manual processes and inefficient collaboration strategies. Forward thinking organizations are looking to increase efficiency, reduce costs related to slow manual processes and improve regulatory and quality approvals by leveraging technology vendors that can assist them in performing electronic documentation quickly to help them get green-lit by the FDA. As a way to bridge this gap in clinical trial documentation Massachusetts-based Court Square Group, a leading provider of audit-ready compliant cloud infrastructure for life science companies, has partnered with life sciences publishing company, e-Submissions Solutions, to develop RegDocs365. Keith Parent and Antoinette Azevedo, founders of Court Square Group and e-Submissions Solutions respectively, built the RegDocs365 platform with specialized modules that comply with the FDA 21 CFR Part 11 compliance mandate, which dictates the requirements for electronic documentation and e-signature concerning clinical trials. “RegDocs365 has the right functionality to enable research organizations of all sizes, CROs, and trial sponsors in executing efficient electronic documentation processes while complying with FDA regulations,” says Keith Parent, founder and CEO at Court Square Group.

Founded in 1995, Court Square Group was built to help pharma and life science businesses leverage technology to improve clinical trial management and regulatory submissions. Conventionally, as CROs and sponsors have to focus on the scientific aspects of a trial, they need a partner with the industry expertise in the clinical trial ecosystem, quality systems, and regulatory requirements as well as IT aspects of the pharma business. To help these organizations, Court Square Group offers best-of-breed electronic documentation and signature solutions as well as best-suited workflows and inter-application integration to drive fast and secure data transfer and management.

RegDocs365 has the right functionality to assist research organizations of all sizes, CROs, and trial sponsors in performing efficient electronic documentation while complying with FDA regulations

“By providing a strong baseline and a consistent repository of critical information, we help our clients find solutions to the most perplexing problems in their operations,” adds Parent. Today, the company has transformed into a leading organization in the clinical trial management and audit readiness market owing to its unparalleled portfolio of cloud-based solutions that comprise qualified document hosting and management, validated disaster recovery, long-term archiving, and other strategic life science technology services.

To ensure the delivery of unmatched safety, efficiency, and compliance, Court Square Group starts every client engagement with a qualification process for a firm’s software, hardware, and data management systems. “As every clinical trial is audited by the FDA, it is important that pharma companies start from a foundation that is designed to prepare them for the inevitable audit. Therefore, we not only ensure compliance in our client’s data infrastructure but also assist them in following best practice SOPs on an ongoing basis,” states Parent. At the same time, Court Square Group’s quality team becomes a part of a customer’s audit process and enables the use of pre-configured SOPs from their RegDocs365 implementation. It includes procedures for the establishment of compliant disaster recovery, backup, and storage of client data. Court Square Group also offers 24/7 support services to handle customer queries from across the world, including data migration and integration services for clients that have multiple subsidiaries and tech deployments across their operational footprint.

The company is currently helping its clients implement its RegDocs365 platform to enable remote management of electronic documentation and data management processes while remaining compliant with the emerging regulations. Additionally, the company has built dedicated environments where auditors can remotely and securely assess the critical aspects of its client businesses’ operations. Court Square Group offers learning management, SOPs, and quality management modules for their platform in order to help clients make a holistic impact on their trial-running capabilities.

Looking ahead, Court Square Group is adding video capabilities into RegDocs365 to enable informed consent for clinical trials and virtual investigator meeting functionality. Court Square is continuously adding new functionality to support additional client needs beyond the e-submission space and into the core manufacturing space. Learn more about FDA compliant IT solutions at CourtSquareGroup.com