BIOSTATISTICS & STATISTICAL PROGRAMMING
BIOSTATISTICS & STATISTICAL PROGRAMMING
Crescentyards offers biostatistical services in Clinical Trials phases I to IV and Real World Evidence and Outcome Research. These services are provided to the pharmaceutical industry as a part of a clinical study, as a stand-alone or as a consulting service.
We have proudly delivered expert clinical trial statistical analyses and programming to all phases of drug development in a wide range of therapeutic areas. In that time, our biostatisticians and SAS® programmers have built a reputation of excellence by being responsive and collaborative, producing quality deliverables, and maintaining the highest level of scientific integrity.
When you work with us, you can be as hands-off or as hands-on as you want to be. For example, you can provide just the study protocol, SAP, data, and CRFs, and we’ll deliver validated output. Or, you can provide us with very detailed specifications and perform the validation in-house. Whatever your biostatistical or clinical trial programming needs, Crescentyards’ staff have the skills and experience to produce high-quality, accurate, on-time deliverables.
Biostatistics is a necessity for clinical trials, and making sure you choose the right statistical advisor is imperative. Our extensive operational experience in this field provides a competitive advantage for your drug development program.
Protocols and statistical analysis plans are the most important documents in your drug development program. The Crescentyards statistical team has experiential knowledge about statistical methodology and its applications to clinical trials and drug development. Our biostatisticians use the most valid and powerful statistical analysis methods to maximize the probability of technical success of your program.
Our Services Include:
Randomization schedules
SAP Development and Review
Randomization Schedules
Writing statistical sections of the clinical study report (CSR) & Review
Statistical Tables, Figures, and Listings development
CDISC Implementation (SDTM and ADaM Datasets, SDTM Annotated CRF, define.xml Files)
Development Safety Update Report (DSUR) support
Integrated summaries of safety and efficacy
Pharmacokinetic (PK) and Pharmacodynamics (PD) analysis
CRF Tabulations and Patient Profiles
Data Management Listings
Edit Checks
General SAS Dataset Remapping/Restructuring
