Blue Dot LLC provides clinical data management and biometrics consulting for biotech sponsors, CROs, and FSP partners.
Services
Quality & CRO Oversight
Sponsor-side quality oversight, CRO selection and performance management, audit support, and inspection readiness. With 19 years of CRO-side experience we provide direct knowledge of where things go wrong, what auditors look for, and how to fix it.
Data Management & EDC
Study startup through execution to database lock. EDC design and build across platforms including Medidata Rave (certified, advisory board member), Medrio, and Viedoc. Edit check programming, data management plans, data transfer agreements, patient profiles, safety and medical data review.
Standards Development
Customized CRF development, CDISC implementation and standards strategy: CRF libraries, conventions, process SOPs. Our aim is to provide consistency across studies, not just compliance.
Financial Planning & Tracking
Biometrics budgeting, resource forecasting, cost driver analysis, vendor tracking.
Analytics & Data Infrastructure
Centralized clinical data warehouses (Snowflake, Microsoft Fabric, SAS Viya) integrating study data into a single platform with operational KPIs and metrics. Reporting through Power BI, R Shiny, or your existing stack. Available as a standalone service.
About
Blue Dot LLC was founded by Daniel Kowalski, a clinical data management and biometrics executive with 19 years of CRO experience spanning organizations from mid-size specialty firms to top-10 global CROs.