Statistics and SAS Programming Services
Expert Staff, Exceptional Service.
Knowledge
Composed of Ph.D. and M.S. level statisticians and SAS programmers, ClinOps, maintains an efficient, experienced staff that is available to assist you with protocol design and development, post database lock programming and analyses as well as submission preparation. ClinOps’ statisticians are highly skilled in every aspect of experimental design and are also able to determine study objectives and to develop statistical analysis plans that deliver the requisite data for all of your clinical, regulatory and marketing needs.
Experience
The combined experience of the departments equals nearly 100 years of SAS/statistical experience within the biotechnology, pharmaceuticals and medical device industries. Our staff has worked with over 75 Biotechnology, Pharmaceutical and Medical Device companies in almost all therapeutic areas prior to joining the ClinOps team.
Service
The ClinOps Statistics Group...- Works closely with our clients throughout the development of all programmed deliverables
- Evaluates your clinical data to integrate your databases across any platform, prepare integrated summaries of safety and efficacy and meet with the FDA to accelerate the regulatory review process
- Prepares submissions to support your product labeling and advertising claims
Services provided by the Statistics group include:
- Protocol review and development
- Study design
- Sample size and power calculation and justification
- CRF review and database review
- Randomization schedules and implementation
- Statistical Analysis Plans
- Table and listing validation and quality-control
- Statistical modeling and analysis
- Interim and meta–analyses
- Integrated summary of safety and effectiveness preparation
- Clinical Data Interchange Standards Consortium (CDISC) conversion including mapping documentation, SDTM and ADaM data domains, define.pdf, varlist.xls and datalists.xls documentation
- Data Safety and Monitoring Board (DSMB) participation
- Customized statistical analyses
- Adaptive design
- Serve as the Sponsor’s statistical representative at FDA pre– and post– submission meetings and FDA advisory panels
- Experience in PMAs, NDAs, SMCs, DMCs
Services provided by the SAS Programming group include:
- Tables, listings and figures programming
- Analysis dataset programming and documentation
- Patient profiles
- Physician reports
- Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Mapping