Clinical Study Reporting

PHASTAR has a unique approach to the analysis and reporting of clinical trials. All our staff are trained in "The PHASTAR Discipline" - our in-house philosophy relating to the methodology of clinical trial data analysis and reporting.

We have experience in the following therapeutic areas:

  • Oncology
  • Rheumatoid Arthritis
  • Asthma, COPD and Respiratory Diseases
  • Vaccines
  • Pain, Headache, Migraine
  • Metabolic Disorders (e.g. Diabetes, Lipids)
  • Haematology
  • Cardiovascular
  • Gastro-Intestinal
  • Anti-Infectives
  • Dermatology
  • Neurological Disorders (e.g. Depression, Epilepsy, MS)

We cover all phases including the following types of studies:

  • Adaptive designs
  • Crossover and parallel group
  • Drug interaction
  • Absolute and relative bioequivalence
  • Radiotracer
  • Superiority, equivalence and non-inferiority
  • SAD/MAD
  • Food effect
  • Meta-analyses and Integrated datasets
  • Observational
  • Single dose and steady state
  • Special populations e.g. renal and liver impairment studies

CDISC

PHASTAR's Programming Division provides CDISC services, in particular, the creation of SDTM and ADaM datasets, as well as the development of dataset specifications.

If you have a submission approaching with legacy format datasets, PHASTAR can upgrade these to CDISC compliant datasets (SDTM and ADaM). 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.

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