Data Management 365

Data Management 365 (DM365) is a software company specialising in clinical trial technology, founded by IT professionals, doctors, and researchers with direct experience in clinical research. The company develops and maintains MainEDC™, an integrated eClinical platform designed to support medical research of any complexity. DM365 serves pharmaceutical companies, biotechnology firms, and contract research organisations (CROs), and has worked with over 100 sponsors globally, managing more than 2,500 trials and registering over 1,000,000 subjects across 20 therapeutic areas and all clinical study phases (I–IV). The company is a spin-off of Flex Databases.

DM365 places particular emphasis on internal competence in Clinical Data Management and Data Science, using this expertise to improve the MainEDC™ platform through real-time feedback, share best practices with clients, and facilitate technology transfer. The platform has been used in studies covering medical devices, dietary supplements, veterinary medicine, nutritional research, consumer product market research, and cosmetics, including one of the largest nutritional studies in Europe.

MainEDC™ Platform — Core Modules and Capabilities

• Integrated EDC (Electronic Data Capture) and IWRS (Interactive Web Response System) within a single ecosystem
• IRT (Interactive Response Technology), eCOA (Electronic Clinical Outcome Assessment), eConsent, Risk-Based Monitoring (RBM), PACS, and Artificial Intelligence components integrated into the MainEDC™ ecosystem
• ePRO (Electronic Patient Reported Outcome) module for capturing patient-reported data
• Visual Edit-checks Builder for prompt and flexible eCRF construction
• Investigator access via a dedicated web portal (www.yourcompany.investigator.site)
• AI-based automated medical coding, described as the first market solution of its kind
• Ready-to-use tools, templates, and data management and data science best practices to support rapid study deployment

Deployment and Performance

• Median time to First Patient In (FPI) of 9.2 days after study start; the platform has achieved FPI in as few as 2 days
• Average project start time can be reduced to approximately 5 days, compared to an industry average of 12.7 weeks
• Supports trials with up to 70,000+ subjects
• Quick deployment and adjustment to protocol amendments
• Pay-as-you-go pricing model with fixed, transparent pricing
• Reported cost savings of up to 80% on platform costs (EDC, ERT, eCOA) and up to 75% on clinical monitoring
• Private cloud hosting with premium security

Compliance and Standards

• ICH GCP E6(R2)
• HIPAA
• GDPR
• 21 CFR Part 11
• GAMP 5
• CDISC
• MedDRA
• Supports regulatory submissions to FDA, EMA, and other authorities
• Experience with audits and inspections; the company assists MainEDC™ users in responding to auditor and inspector questions related to the platform

Technology Transfer and Client Support

• Technology transfer programme involves sharing DM365 expertise in data management, data science, and drug supply management through collaborative work on client projects, typically the client's first project with MainEDC™
• Includes transparency throughout project execution, knowledge sharing of best practices and techniques, and ongoing support and analytics
• Tailored support for CROs seeking to reduce resource expenditure, for large pharma sponsors managing complex multi-site trials, and for biotech organisations conducting clinical trials for the first time or infrequently

DM365 has accumulated over 250,000 hours of software development and has achieved successful FDA submissions of study data. The company can be contacted directly at [email protected] and offers free trial access and demonstration scheduling for prospective clients.