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.

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

Oncology Rheumatoid Arthritis Dermatology Pain, Headache, Migraine Antiviral Ophthalmology Medical Devices Rare Diseases Neurological Disorders

Haematology Cardiovascular Gastro-Intestinal Anti-Infectives Asthma, COPD and Respiratory Diseases CNS Immunology Metabolic Disorders

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 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.