Services

Consultancy

We provide expert, in-depth advice on management, processes, and systems. We collaborate closely with our clients to help them build efficient and reliable technical processes within their clinical development environments.

Onsite Programming
Support and Solutions

We provide integrated programming teams who deliver measurable results with every engagement. By using seamless, best-of-class solutions onsite, your clinical development process is virtually uninterrupted.

Offsite Programming
Support and Solutions

We deliver quality results with a minimum footprint. Our internal teams can use a client’s infrastructure remotely or execute the work within our own structure, depending on your needs.

On-Demand

Combining our expertise and consulting capabilities, On-Demand brings a wide array of services to your problem solving.


Programming Services

  • Implementation and Validation
    • Clinical System Implementation and Validation
    • EDC Implementation Plan Design
    • Applications Development
  • Database Programming
    • Trial Setup, Including CDISC Compliant CRFs
    • Global Library Management
    • Edit/Validation Check Development
    • Vendor Data Transfer Programming
    • Medical Dictionary Management
    • Trial Locking and Archiving Activities
  • Statistical Programming
    • Statistical Table, Listing, and Figure Programming
    • Data Monitoring Programming
    • Analysis Dataset Programming
    • Validation of Statistical Outputs
    • Integrated Summary Programming
    • Ad Hoc Programming
  • CDISC
    • CDISC/SDTM/ADaM/eCTD Programming Support for FDA Submissions

Process and Management Consulting Services

  • Budgeting Management Strategy
  • In-Sourcing Management Strategy
  • Out-Sourcing Management Strategy
  • Process Improvement Strategy
  • Technology Strategy
  • Management of In-Sourced Staff
  • Management of Out-Sourced Staff
  • Standard Operating Procedure Development