Platform lead: Dr. Ross Tsuyuki
Our goal is to support researchers with specialized expertise around the logistics of completing a trial focused on patient-oriented, clinical, health services and outcome research. We have access to a range of experts in the field such as study coordinators, project managers, data managers, methodologists and statisticians who can assist you with tools and database development, data management, data collection management processes and completion.
Our work is closely linked with the Data Platform and the Methods Support & Development Platform. We recommend that you also review the services offered by these platforms. The focus of the Data Platform is on secondary analysis of big data sets, and the focus of the Method Support & Development Platform is on developing innovative methods for completing patient-oriented research.
Services we offer
Once you have a solid research idea in mind, we can help move your idea into a practical plan. This could include a wide range of factors that require consideration such as the outcome measures, data collection tools, and more.
Development of analytical plans
We can provide consultation and services around the development of biostatistical plans to help you determine the most appropriate way to best test your hypothesis.
Sample size calculation
We can review your suggested project design to ensure that the study population and outcome measures are well defined. This information will then be used to calculate the number of individuals who need to take part in your study.
Within clinical trials it is recommended that you have a person independent of the research team responsible for the randomization process. We can do this on your behalf for both individual participants in patient randomized trials or centres within cluster randomized trials.
We can undertake database development on your behalf using the REDCap online data management system to ensure it meets requirements for your research study. The database will ensure that all the data points are capture according to the study protocol and organized logically with minimal redundancy to improve performance and reduce data retrieval errors. Ongoing database management can also be provided.
Development of case report forms
We can develop case report forms. These forms play a vital role in clinical trials as they are used to collect information required by the protocol. A well designed form can make data collection and entry more efficient benefiting the subsequent data management and statistical analyses.
Clinical event adjudication
The Consultation Research & Services Platform can interrogate clinical trial datasets to identify clinical events which are potential study end point events and arrange blinded independent assessment to determine whether they are clinical endpoints for your study.
Consultation Research & Service Platform are can undertake data entry on your behalf using Case Report Forms and Questionnaires provided. Quality assurance procedures are run on all data which is entered in-house to ensure the highest standards of quality.
We can undertake quality assurance activities (removing or correcting data points or datasets as required) to ensure that the data housed is of the highest possible quality for the purpose which it is to be used.
We have access to analysts with expertise in complex statistical analyses and can undertake this area of the project on your behalf.
We offer comprehensive project coordination of your project. This may include obtaining ethics and administrative approvals, preparing reports for data and safety monitoring boards, recording information on occurrence of adverse events and completing financial reporting.