Services
CDISC
Building on the advantages of standardization, the Clinical Data Interchange Standards Consortium (CDISC) has provided extensive guidelines for the collection, analysis and submission of clinical trial data for regulatory compliance purposes. Today CDISC standards are widely accepted by the industry and regulatory agencies, therefore necessitating the need of conversion of existing data into CDISC standards.
Ephicacy is a CDISC Gold member. Our thorough understanding of CDISC standards, superior statistical programming capabilities and integrated tools and processes enable us to deliver CDISC compliant deliverables with greater efficiency.
Our CDISC Services
- Conversion of Legacy raw data into SDTM datasets
- Compliant Submisson Data Packages – SDTM annotated CRF, define.xml
- Analysis ready ADaM domains, ADaM define.xml
- Validation documents and OpenCDISC Report
- Reviewer’s Guide
- SDTM/ADaM Compliant Integrated Databases
We follow a three pronged approach to deliver high quality CDISC services to our clients:
Process
- Established procedures, work instructions and checklists
- Defined workflow to generate SDTM and AdaM standard data packages
- Validation and verification strategy to ensure integrity and accuracy of deliverables
- Project management to ensure smooth project execution
People
- Expert programmers with prior domain experience
- Exposure of implementing CDISC standards in diverse therapeutic areas
- Emphasis on continuous learning and training to remain abreast with latest standards
Tools
- Use of latest technology framework like OpenCDISC Validator to ensure adherence to standards
- In-house Macro library with pools of SAS macros and utilities to achieve efficiency in conversion process
- Automated system to generate Define.XML
Why choose Ephicacy
Ephicacy has a well-established global practice in FSP and Project-based services in statistical programming, biostatistics, data management and real-world evidence with presence in US, Canada, and India. Ephicacy has been a solid partner for providing high-end yet cost effective resources for sponsors. With increasing cost pressures, Ephicacy is continuing to provide huge benefits to our clients in resourcing and delivery strategy by leveraging our global footprint.
FSP Engagement Success Story
Ephicacy leveraged its expertise in FSP services for a top ten pharma Company
Project-Based Services
Manage multiple, complex statistical analysis deliverables for multiple studies, CDISC...
Clinical Data Management
Our client is an emerging Pharma company with treatment solutions in multiple therapeutic...