MEDICAL WRITING SPECIALIST IN AUSTRALIA

Southern Star Research are experts in the requirements of the local regulatory authorities in the countries we operate. We can assist with the review and / or writing of clinical study protocols / clinical investigation plans and clinical study reports (CSR) to ICH-GCP formats to ensure essential clinical data points are obtained and reported to support clinical regulatory and commercial objectives.

PROTOCOL REVIEW / WRITING

Southern Star Research’s collaborative team is particulary astute at assisting with the development of early phase protocols, clinical investigation plans (CIP) and study designs.

VISIT EARLY PHASE SPECIALISTS

Our in-depth knowledge of local treatment practices and standards of care ensures that our protocols / CIPs not only maximise scientific evaluation but are also practical at sites, boosting investigator interest and engagement, and with subject recruitment in mind. Our experienced team have established relationships with many therapeutic area Key Opinion Leaders who can provide their expert opinion prior to finalisation of the protocol / CIP.

CLINICAL STUDY REPORTS

Once the study has been completed, it is essential to accurately and distinctly represent the data collected. Our Medical Writers, together with our Biostatisticians can collate the results, analysis and interpretation into a clear, concise and comprehensible Clinical Study Report that satisfies the content and format requirements of ICH-GCP.

Our experts can assist with:

  • Trial Concept Design
  • Endpoint Development and Evaluation
  • Input into Pharmacokinetic and Pharmacodynamic Considerations
  • Statistical Sample Size Calculation
  • Statistical Analysis and interpretation
  • Medical Writing of Protocols and CSRs to ICH-GCP standards