Statistics & Data Corporation (SDC)
SDC is a technology-enabled contract research organization (CRO) founded in 2005 that provides biometrics and clinical data services to pharmaceutical, biologic, and medical device companies. Core capabilities include biostatistics, clinical data management/EDC, interactive response technology (IRT/RTSM), eSource/eConsent/ePRO solutions, pharmacovigilance, regulatory submission support, and AI-enabled centralized data warehousing and reporting for decentralized, hybrid, and traditional clinical trials.
Industries
Nr. of Employees
medium (51-250)
Statistics & Data Corporation (SDC)
Products
AI-enabled centralized clinical data hub
A centralized data lake that aggregates and harmonizes clinical data across systems to enable unified analytics and reduce duplicate data handling.
System-agnostic real-time reporting platform
Real-time dashboards and reporting that consolidate metrics and operational visibility across EDC, IRT, eSource, and other clinical systems.
BYOD-capable ePRO/eCOA solution
Validated electronic patient-reported outcome solution supporting bring-your-own-device strategies and provisioned devices to reduce costs and increase patient adherence.
AI-enabled centralized clinical data hub
A centralized data lake that aggregates and harmonizes clinical data across systems to enable unified analytics and reduce duplicate data handling.
System-agnostic real-time reporting platform
Real-time dashboards and reporting that consolidate metrics and operational visibility across EDC, IRT, eSource, and other clinical systems.
BYOD-capable ePRO/eCOA solution
Validated electronic patient-reported outcome solution supporting bring-your-own-device strategies and provisioned devices to reduce costs and increase patient adherence.
Services
Biostatistics
Statistical design, analysis, adaptive design expertise, and regulatory interaction support for clinical programs.
Clinical Data Management / EDC
End-to-end data management: CRF and database design, build, validation, query management, datasets for submission, and integration with other eClinical systems.
IRT / Randomization and Trial Supply Management
Configuration and operational support for randomization and trial supply, integrated with EDC and reporting systems.
eSource and ePRO/eCOA deployment
Validated eSource implementations, BYOD-enabled ePRO/eCOA deployments, eConsent and digital patient data capture to reduce site burden and improve data quality.
Pharmacovigilance and safety services
Integrated SAE capture within EDC, global safety surveillance, regulatory outputs, and safety signal management workflows.
Regulatory consulting and submission support
Regulatory strategy, preparation of ISS/ISE and submission-ready materials, representation with regulatory agencies, and support from pre-IND through approval.
Biostatistics
Statistical design, analysis, adaptive design expertise, and regulatory interaction support for clinical programs.
Clinical Data Management / EDC
End-to-end data management: CRF and database design, build, validation, query management, datasets for submission, and integration with other eClinical systems.
IRT / Randomization and Trial Supply Management
Configuration and operational support for randomization and trial supply, integrated with EDC and reporting systems.
eSource and ePRO/eCOA deployment
Validated eSource implementations, BYOD-enabled ePRO/eCOA deployments, eConsent and digital patient data capture to reduce site burden and improve data quality.
Pharmacovigilance and safety services
Integrated SAE capture within EDC, global safety surveillance, regulatory outputs, and safety signal management workflows.
Regulatory consulting and submission support
Regulatory strategy, preparation of ISS/ISE and submission-ready materials, representation with regulatory agencies, and support from pre-IND through approval.
Expertise Areas
- Clinical trial management
- Biostatistics and statistical consulting
- Clinical data management and EDC
- IRT/RTSM implementation
Key Technologies
- Electronic data capture (EDC)
- Interactive response technology (IRT/RTSM)
- eSource systems (real-time point-of-care capture)
- ePRO / eCOA with BYOD support