Datapharm Australia is attending the Pharmaceutical Development Conference (PDC) in Sydney, Australia. We look forward to connecting with you. PDC connects pharmaceutical scientists and professionals, product sponsors, solution providers, business development executives and students to discuss industry's challenges related to pharmaceutical formulations, manufacturing, analytical method, preclinical, and clinical development.
Daniel Morrison and Gabriel Vigano will both be presenting at PDC 2025:
Daniel Morrison: Protocol Development in Clinical Trials
The Clinical Study Protocol provides a foundation for a study to be run successfully. It defines the rationale and scope of the study, and provides all relevant information for stakeholders. When Protocol development is approached in conjunction with clinical design, many challenges can be identified and corrected in the early stages of the study, saving time and money in the long run. In this presentation, we will explore the process of Protocol development in clinical trials, including ICH-GCP guidelines and regulatory requirements. Working with an experienced CRO provides access to expert consultation to improve efficiency and maximise outcomes for your clinical trial. We will examine how to best approach Protocol development as an integrated part of clinical study design.
Gabriel Vigano: Robust Data Handling: Challenges and Considerations
The success of any clinical trial is dependent on its data. While the importance of the data itself is self-evident, its format, storage, and handling are equally so. Through various examples, this will highlight the importance of strategic data handling at the outset of a study. The differences and choices one makes within their electronic data capture (EDC) platform of choice will dictate analytical ease and data quality. In addition, data structuring and formatting decisions also feed into this and other processing tasks, such as CDISC and ADAM datasets. Being aware of and choosing the right choices for your study will streamline workflows and ultimately contribute towards the success of a clinical trial.
Get in touch with our team to discuss your clinical trial here.