DDOTS

DDOTS develops research management software for clinical trial sites and research organizations. The platform covers protocols, participants, pharmacy, eRegulatory, and specimen management within a single unified environment, allowing users to access multiple solutions through one log-in. DDOTS has been building and refining research software for nearly 30 years, with a focus on affordability, configurability, and long-term client partnerships.

The platform is designed to integrate with existing systems through HL7-based EHR interfaces, a public API for connections to accounting and other departments, and single sign-on support. All solutions include integrated eRegulatory functionality, eliminating the need for a separate document management system. Electronic documents and Part 11-compliant electronic signatures are available across every module.

Core Solutions

• CTMS: Provides enterprise and site-level management of clinical trial start-up, enrollment, compliance, financials, and reporting. Features include site activation, protocol data management, schedule of events and budget, key personnel activity tracking, monitor access and activity logging, participant recruitment and enrollment, visit calendars, deviation and adverse event tracking, re-consenting, invoicing and payment tracking, accounts receivable allocation, billing compliance tools, and coverage analysis.
• Pharmacy: Manages investigational drug accountability and regulatory compliance. Supports receipt, dispensing, return, and destruction of agents, and generates customizable drug accountability record forms (DARFs) to meet sponsor requirements. Additional capabilities include inventory management with expiration notifications, transport management between pharmacies with automated accountability records, transport verification prior to dispensing, custom label printing, financial event capture and invoicing, participant dispense visit calendars, and monitor access with electronic verification.
• Biorepository: Manages biorepository samples alongside clinical trial data within the same integrated platform, reducing data silos and supporting operational efficiency.
• IRB: Handles clinical trial and IRB submission management within the unified platform, streamlining workflows and supporting study oversight from initiation through completion.

Integrated eRegulatory

• Electronic documents: Stores trial-related documents — including protocols, investigator brochures, consent forms, monitoring reports, and regulatory submissions — in a secure, centralized location accessible to authorized users.
• Electronic signatures: Supports requesting, tracking, and signing documents electronically using Part 11-compliant electronic signatures, with the aim of reducing overall trial timelines.

Platform Capabilities

• Single platform: Multiple connected solutions operate under one log-in to streamline workflow across departments and functions.
• Integration: Interfaces with EHR systems via HL7, supports API connections to accounting and other systems, and enables single sign-on for security and simplified user access.
• Configurability: Offers extensive system configuration options to customize each module's behavior and data management approach.
• Reporting: Includes over 100 out-of-the-box reports covering protocols, participants, regulatory matters, financials, and more, with custom reports available on request.
• Remote access: Cloud-hosted environment allows users to access systems from any location, supporting remote work and cross-site collaboration.
• Affordability: Pricing is structured to be accessible to as many research sites as possible.

Availability, Security, and Support

• Proactive maintenance: Systems are monitored and maintained on an ongoing basis to prevent issues and optimize performance.
• Timely updates: Software is kept current with feature releases, security patches, and enhancements.
• Data retention and recovery: Data is stored in a cloud environment accessible from anywhere to support business continuity.
• Training and support: Support is provided through direct contact with a real person as well as online tools. DDOTS also operates an issue capture system intended to identify problems proactively before users report them.