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.

 

biometrics

​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