The Australian Pharmaceutical Biostatistics Group (APBG) welcomes you to join this webinar on Working in at Team – Statistician – Data Manager – Medical Writer presented by Statistician Belinda Butcher, Medical Writer Sophie Gibb and Clinical Data Manager Leanne Stootman, all from WriteSource Medical. 

Date/Time: Tuesday 22nd October 2 to 3pm (Sydney time)

Location: Online (please contact us at apbgsteering@gmail.com for virtual meeting details)

Abstract

The production of high-quality clinical trial research requires the cooperation of various functional groups. Biostatisticians, data managers and medical writers are key people responsible for ensuring the research is cohesive through the design, implementation, analysis and reporting phases. Effective collaboration between these groups of people is critical to streamline the production process and ensure consistency within the research itself and of documentation produced through a trial.

The various documents and systems required for a trial are highly related with a given study design, objectives, endpoints and other elements flowing from these.  The medical writer, statistician and data manager, should be introduced at the start of a project and be supported in working collaboratively together throughout the trial to ensure high quality, consistent documentation and research outcomes.  We share some of our experiences of working as a multidisciplinary team – what is effective, and case studies illustrating some potential pitfalls of insufficient communication and where cross-functional responsibilities are not clearly understood.

Speakers

Belinda Butcher is the director of WriteSourceMedical Pty Ltd, a medical writing, data management and biostatistics consultancy.  She has dual expertise in pharmacology and statistics.  Sophie Gibb is the medical writing manager at WriteSource Medical Pty Ltd, she has extensive experience in regulatory writing and medical communications for drug sand devices in a diverse range of therapy areas.  Leanne Stootman is the manager of clinical data management at WriteSource Medical Pty Ltd, she has a broad experience including data management, clinical operations and quality.