Key services
- 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
Expertise covering a wide range of therapeutic areas

We cover all phases including the following types of studies:
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Get in touch with our team
CDISC
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.
Expert study design, statistical analysis, data science, data capture, and reporting for clinical trials
Contact
Tel UK: +44 (0)20 7183 7062
Tel US: +(1) 646 851 2624
UK HQ: 2D Bollo Ln, Chiswick,
London, W4 5LE
US HQ: 300 w. Morgan street suite 120,
Durham, NC, 27701
