Project Plan - CDISC Implementation
CDISC standards have been in development for many years. There are now methodologies and technologies that would make the transformation of non-standard data into CDISC-compliance with ease. Clinical trials have evolved and become more complex and this requires a new set of skills outside of clinical research - Project Management.
Our project management team handles all requirements.
RA eClinica full-service capabilities allow us to handle an entire program or the services specifically needed by our clients, from protocol strategy to regulatory submission and post-marketing. Our project management responsibilities include:
- Primary Liaison with Client
- Team Management (Internal and External)
- Timeline Management
- Budget Management
- Project Status Reporting
- Risk Mitigation/Management
- Vendor / CRO Management
The team is engaged with various associations such as the (CDISC), Society for Clinical Data Management (SCDM), Association for Clinical Data Management (ACDM), Project Management Institure (PMI) and Drug Information Association (DIA), being always up to date with the latest innovation regarding data management procedures.
Need SAS programmers? RA eClinica can help provide resources in-house / off-shore to facilitate FDA review by supporting CDISC mapping, SDTM validation tool, data conversion and CDASH compliant eCRFs.