Clinical Trials Specialist

Vicki Partridge Pty Ltd (VPPL) has put together a team of clinical trials specialist organizations to cover all aspects of clinical trials undertaken within Australia, including:

These activities are undertaken by suitably qualified and trained personnel or a clinical trials specialist, who specifically look for:

• Failure to follow the protocol;
• Failure to keep adequate and accurate records;
• Problems with the informed consent form;
• Failure to report adverse events; and
• Failure to account for the disposition of study drugs or devices.

These activities are undertaken by suitably qualified and trained personnel or a clinical trials specialist, who specifically look for:

• Failure to follow the protocol;
• Failure to keep adequate and accurate records;
• Problems with the informed consent form;
• Failure to report adverse events; and
• Failure to account for the disposition of study drugs or devices.

VPPL utilizes an electronic Case Report Form (eCRF) rather than paper-based Case Report Form (CRF), as the use of an eCRF:

• ​avoids the development of a paper CRF, reducing the costs associated with development, printing, and shipping;
• avoids the significant cost of data entry of the paper CRF;
• avoids the cost of paper discrepancies; and
• reduces the number of discrepancies between the site and data management.

This critical phase is managed by dedicated clinical trials specialists. They oversee data accuracy and ensure regulatory compliance.

​The Data Management stage of a Clinical Trial includes:

• ​Data Quality plan including study specific data management processes, roles, and responsibilities;
• eCRF and database and associated eCRF completion guidelines
• CFR 21 part 11 compliant OpenClinica Database and associated validation checks;
• Training trial personnel in eCRF completion, transmission, and validation processes; and
• ​Preparation of all final data management documentation for archival with the study documentation.

​Biostatistics is the application of statistical techniques to health-related fields. Its foundation is the mathematics of variability and it encompasses the science of designing quantitative research studies, managing and analyzing data, and interpreting the results. Vicki Partridge Pty Ltd utilizes experienced clinical trials specialists and biostatistics professionals to ensure the validity of trial results.

The final stage of the Clinical Trial is a production of the Clinical Report, which VPPL ensures is fully compliant with the relevant ethics Committee and regulators requirements.