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.

PHASTAR has experience in all therapeutic areas, including:

  • Oncology
  • Rheumatoid Arthritis
  • Dermatology
  • Pain, Headache, Migraine
  • Antiviral
  • Haematology
  • Cardiovascular
  • Gastro-Intestinal
  • Anti-Infectives
  • Asthma, COPD and Respiratory Diseases
  • CNS
  • Opthalmology
  • Medical Devices
  • Rare Diseases
  • Immunology
  • Metabolic Disorders (e.g. Diabetes, Lipids)
  • 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
  • SAD/MAD
  • Food effect
  • Meta-analyses and Integrated datasets
  • Observational
  • Radiotracer
  • Superiority, equivalence and non-inferiority
  • Single dose and steady state
  • Special populations e.g. renal and liver impairment studies

Our services include:

  • 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
  • Define.xml and/or define.pdf
  • Meta-analyses and Integrated datasets
  • Observational and real-world evidence studies
  • CDISC compliant documentation
  • Annotated CRFs
  • Superiority, equivalence and non-inferiority
  • Clinical pharmacology studies (e.g. drug interaction, bioequivalence, radiotracer, food effect, special populations, renal and liver impairment studies)

CDISC

PHASTAR's Programming team provide expert CDISC services 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). PHASTAR’s senior team has extensive experience with regulatory bodies and participate in regular 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.

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