DSG

DSG develops and provides clinical trial software and data management solutions for the biotechnology and life sciences industries. The company's flagship platform, eCaseLink, is a unified system that supports both decentralized clinical trials (DCT) and traditional clinical trials within a single integrated environment, covering electronic data capture (EDC), direct data capture (DDC), eCOA, eConsent, RTSM, TeleVisit, and participant tracking. DSG has over 30 years of experience in clinical trial software and has served more than 400 companies across 25,000+ sites in 93+ countries.

DSG incorporates Clinical Data Science (CDS) capabilities into eCaseLink, enabling the execution of complex protocol designs using a patient-centric, data-driven, and risk-based approach. The company has also partnered with 1nHealth, a global digital patient recruitment provider, to integrate pre-screened participant leads from 1nHealth's platform directly into DSG's Enrollment Tracker, creating a connected experience from study launch through completion.

Participant Recruitment Solutions

• eConsent: Supports remote participant enrollment by reducing barriers to entry and enhancing engagement through a step-by-step instructional approach using text, graphics, and multimedia options.
• Participant Tracker: A platform for registering and tracking pre-screened participants, designed to help study teams meet enrollment goals and maintain control over recruitment monitoring.
• TeleVisit: Enables communication with participants at any time and from any location, reducing the need for on-site visits.

Visit Planning Solutions

• Direct Data Capture (DDC): A bring-your-own-device (BYOD) approach to real-time data capture that eliminates source data verification (SDV) and allows users to enter data from any device, supporting decentralized and hybrid clinical trials.
• eCOA: Replaces paper-based surveys, allowing participants to complete questionnaires in real time using a mix of traditional data fields, visual analogue scales (VAS), numeric and verbal rating scales, and audio recordings. Supports integration with sensors and wearables.
• eCaseLink EDC/DDC: A site data entry platform with real-time data export for analytics including SAS. The platform has been used in the approval of multiple drugs across various regulatory agencies over its 30+ year history.

Study Management Solutions

• RTSM (Randomization and Trial Supply Management): A fully integrated system providing real-time data to manage participant randomization, investigational product (IP) inventory, supply, and re-supply. Includes direct-to-patient IP delivery.
• Visit schedules for hybrid and decentralized trials can be deployed with support for in-home visits and automatic participant reminders.
• Study data can be downloaded at any time in any format for statistical analysis and regulatory submission.

Platform Capabilities and Differentiators

• Agile Implementation: Studies are typically implemented in 4–6 weeks, with over 200 studies across twelve years implemented in under two weeks.
• Technology Firsts: DSG was the first to provide a fully integrated EDC-RTSM-Trial Supply Management system, the first to achieve FDA drug approval using eSource/DDC, and has ePRO experience dating back to 1999.
• Flexibility: Supports complex integrations as part of its standard product offerings.
• Global Reach: Supports global trials and clients with region-appropriate cloud hosting services.
• Compliance and Security: ISO/IEC 27001:2013 certified and compliant with HIPAA, GDPR, 21 CFR Part 11, Privacy Shield, and other applicable regulations.
• Pricing: Positioned as more cost-effective than larger providers while offering a broad feature set and flexible pricing.
• Study Rescue: DSG has taken on studies that required rescue from other platforms.
• Partner Tools: The DSG Designer tool allows partners to configure even complex cross-module, cross-visit edits using a point-and-click interface with no coding required, minimizing the training needed to reach proficiency.

DSG describes eCaseLink as the only truly integrated and unified platform supporting both decentralized and traditional clinical trials, and positions its service model and delivery record as a key differentiator from larger clinical trial technology vendors.