statprog inc._introduction_clientlist
TRANSCRIPT
Quality, Flexibility, & Reliability. That’s Our Commitment.
Quality, Flexibility, & Reliability. That’s Our Commitment.
OUR PHILOSOPHY
Quality, experience, commitment and the clients’ trust form the foundation of our
success.
ABOUT US
We specialize in providing statistical and clinical programming services to
pharmaceutical and biotechnology industry. Whether you need a team to support an ongoing project or an adhoc request, we can
provide you with the service that you need.
WHAT WE DO
STATISTICAL & CLINICAL
PROGRAMMING
CDISC: SDTM, ADAM &
DEFINE.XML
AD-HOC PROGRAMMING
FDA SUBMISSION
SUPPORT
We can meet your data analysis needs by providing statistical tables, listings and figures for input in your clinical and statistical
reports.
AdHoc Programming
Programming support to handle any FDA Request post NDA submission
De-identification of database for data-sharing with institution such as Transcelerate Biopharma Inc. or academic institutions
Develop standard macros
Custom Tools
Define generator: We can customize the basic define generator with additional options for value level metadata and controlled terminology based on your database.
NDA Submission Support
Programming support for Periodic Benefit-Risk Evaluation (PBRER)
Programming support for Drug Under Development Safety Update (DSUR)
Experience
Pharmaceutical Companies STATProg Inc. has worked with include Biogen, GSK, Targacept Pharmaceutical, AstraZeneca; as well as CRO: Novella Clinical
