Our services are based on either a staff-augmentation model or managed services approach, or both, including partnering with colleagues in the field, according to client or project needs. We support a flexible outsourcing strategy.
Summary of services provided by DIcore Group team members in connection to the Pharma / Biotech industry:
Data Management & Reporting
- Support during Planning, Collection, Organization, Analysis, Integration, Submission, Archiving
- Assessment, Gap Analysis, Requirements Gathering
- Data and Metadata validation
- Cross-validation of metadata/data and results using license-free software to help improve your ROI
- Support on the use of CDISC Open Core Rules
- Generation of Define-XML directly from your Metadata Repository (MDR)
- Generation of Dataset-JSON files directly from your data repository
- Support for Data Visualization and Data Validation
- Support for CDISC Standards Implementation throughout your tech stack
Software Development
- Gap Analysis and Requirements Gathering
- Development, Implementation and Training
- System Validation
- Support for MDRs and data warehouses
- Connectivity with different SQL database engines; i.e., Oracle, SQLite, PosgreSQL
- Application development using SAS, Python, SQL, scripting and other programming languages
- API integration
CDISC Standards Development, Implementation and Training
- Data Standardization Services to support outsourced client requests for submission to regulatory authorities or diverse internal Clinical Data Standards and Integration client needs
- Content Standards Development or Implementation (CDASH, SDTM, ADaM, Controlled Terminology)
- CDISC Library Integration via APIs
- CDISC ODM Vendor Certification (Program Coordination Team), CDISC CORE (Validation Support)
- Data-Exchange Standards Development: ODM, Define-XML, Dataset-JSON
- CDISC Training: CDISC for Newcomers, ODM, Define-XML, Dataset-JSON, CORE
(CDISC Authorized Instructor(s): Marcelina Hungria)