Phastar is a trusted provider of clinical trial reporting services across all therapeutic areas and phases of clinical trials. Our team of expert biostatisticians and statistical programmers provides deep clinical domain expertise and best-in-class technical skillsets to clients to analyse statistical results on complex life sciences studies with multiple end-points and various experimental designs. Phastar's commitment to quality guarantees accurate, compliant, and effectively presented clinical trial data.

• Reporting of phase I-IV trials
• Integrated summaries of efficacy and safety
• Conversion of legacy data to CDISC standards
• Creation of SDTM and ADaM datasets
• Annotated CRFs

• Define.xml and/or define.pdf
• Observational and real-world evidence studies
• CDISC compliant documentation
• Superiority, equivalence and non-inferiority
• Clinical pharmacology studies

Adaptive designs Crossover and parallel group Drug interaction Absolute and relative bioequivalence SAD/MAD Food effect

Meta-analyses and Integrated datasets Observational Radiotracer Superiority, equivalence and non-inferiority Single dose and steady state Special populations

Phastar's statistical programmers provide expert CDISC services as well as the development of dataset specifications. If you have a submission approaching with legacy format datasets, we can upgrade these to CDISC compliant datasets (SDTM and ADaM). Phastar's senior team has extensive experience with regulatory bodies and regularly participate in regulatory interactions.

We can provide all the necessary associated documentation that a submission to the FDA will require (or other global regulators), including annotated CRFs, define.xml and/or define.pdf and a regulatory reviewer's guide. If you are planning an integrated summary of efficacy and safety, we can help put together CDISC compliant datasets. We can also provide advice on the format of the data that will be acceptable to global regulatory bodies.