ACL Digital’s Functional Service Provider model provides optimized clinical trials management with a flexible mix of functional expertise, resource management, FSP and technology-enabled solutions to reduce your trial period and maximize your global program.
Clinical Data Management
Our Clinical Data Management Team can handle clinical studies of all sizes, from phase I-V, in the FSP model as well as standalone projects.
Our Services include
- Development of case report form (CRF) and Database Validation Processes
- Data Quality Standards Management
- Query Generation and Resolution
- Management of Data Review and Clean-up Process
- Data Management Plan Creation and Maintenance
- Serious Adverse Event (SAE) Reconciliation & coding
- Dictionary Services (MedDRA, Who-DD)
- Remote Data Entry (RDE)CRF Log and Tracking
- Data Locking, Archival, and Storage
- Audit Trail Generation (Per 21CFR Part 11)
- Report Generation
Statistical programming (SAS)
Our team of dedicated programmers have years of SAS® Programming expertise, combined with an in-depth understanding of specific clinical subject matter, which ensures meeting timelines of assigned tasks and quality of the output.
Our Services include
- Programming of Raw, SDTM and Analysis Datasets
- Tables, Listings, and Figures creation and validation
- CDISC conversion of Legacy data
- Implementation of data management plans and approved SAP (Statistical Analysis Plan)
- Post-marketing data analysis and reporting
- Regulatory consultation and representation
Biostatistics
Our Biostatisticians work closely with clients to determine methods for collecting, analyzing and presenting data while maintaining compliance with regulatory guidelines.
Our Services include
- Clinical Trial Design and Protocol Development
- Randomization Schemes
- Independent Statistician Services
- Statistical Analysis plans for different phases of clinical trials
- Interim Analysis/Data Safety Monitoring Boards (DSMBs)
- Development of Clinical Data Interchange Standards Consortium (CDISC) compliant outputs (SDTM & ADaM, Define.xml)
- Tables listing figures (TLF) creation, In-text table, CSR and appendix
- Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Planning, Analyses and e-submission