Major Drugs - Princeton, NJ, US
WHO WE AREData Management 365 is an innovative software development company with profound experience in clinical trials. Originally, Data Management 365 started as a spin-off company of Flex Databases by a team of IT professionals, doctors, and researchers with extensive experience in clinical trials, Data Management 365 understands your needs and expectations of Data Management Software from the inside and applies the most advanced technologies to implement this knowledge in our product. WHAT WE DODM 365 delivers Data Management Software and Services for CRO and Pharmaceutical companies. We bring EDC, IWRS and Drug Supply together in a single software solution - MainEDC™. We deliver Data Management and Drug Management services along with its Technology Transfer: sharing our expertise with you.OUR EXPERIENCE129 sponsors rely on our platform1700+ projects hosted on the platform340,000,000+ fields and data points20+ therapeutic areas & I – IV clinical study phases coverageSuccessful FDA submission of study dataADVANTAGESAdherence to industry's standards and best practices, demonstrating our commitment to customers' security and privacy: 21 CFR Part 11, HIPAA, GDPR, GCP E6/R2, GAМP 5ValidatedPrivate cloud hosting (SaaS)Full audit trail based on blockchain technologyQualified data centers, backup procedures, access controlEffective analytical tools for Sponsor oversight of the clinical data and RBМQuick start-up and closeoutQuick adjustments to protocol amendments (pathways)
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