Services

BioStatistics

Our statisticians have a broad range of knowledge and experience in a variety of therapeutic areas. We have provided full service support for clinical trials, performed ad-hoc analyses, and analyses in support of publications.

Our services include:
  • Study Design
  • Power/Sample Size Calculations
  • Randomizations
  • Protocol Review
  • CRF Design/Review
  • Development of Statistical Analysis Plan
  • Production & Validation of Interim Analyses & Reports
  • Final Statistical Reports
  • Ad Hoc Analysis
  • Independent Review of Statistical Analysis
  • ISS/ISE (Integrated Safety Summary/Efficacy) Packages
  • DSMB Packages

Clinical data management

Our statisticians have a broad range of knowledge and experience in a variety of therapeutic areas. We have provided full service support for clinical trials, performed ad-hoc analyses, and analyses in support of publications.

Our services include:
  • Study Design
  • Power/Sample Size Calculations
  • Randomizations
  • Protocol Review
  • CRF Design/Review
  • Development of Statistical Analysis Plan
  • Production & Validation of Interim Analyses & Reports
  • Final Statistical Reports
  • Ad Hoc Analysis
  • Independent Review of Statistical Analysis
  • ISS/ISE (Integrated Safety Summary/Efficacy) Packages
  • DSMB Packages

Programming solutions

We customize our programming service to meet the unique needs of clients. We have a long history of developing and advancing SAS® coding tools for programming reports. These tools allow us to create customized RTF output. The most recent extensions have proven very useful for generating patient profiles. Our staff continues to develop the company's reporting tools to increase our efficiency.

Regulatory Support

We have extensive experience interacting with the FDA and the knowledge we have gained help our clients' submission processes go smoothly, thus minimizing time to market.

Our regulatory support services include:
  • Consultation & Planning
  • FDA and EMEA Representation
  • IND and NDA Submissions
  • IDE, PMA and 510K Submissions

Report Production

Our team of statistical programmers are trained and supervised by managers with many years of SAS programming experience. The programmers work closely with the biostatistician and project manager to meet the client's goals.

Our report production services include:
  • Independent QC review
  • Statistical packages
  • Customized packages per client specifications
  • Creation of ISS/ISE analysis data sets
  • Profiles