+61 (03) 8786 9374

Melbourne, Australia

©2018 by Resolutum Global Pty Ltd

 

Clinical Data Management

Our clinical data management team is guided by industry standards and strictly adheres to the Good Clinical Data Management Practice (GCDMP) guidelines.

We use the Medrio EDC system as the primary data collection and management tool supported by rigorous internal Standard Operating Procedures.

Our key deliverables include:

  • eCRF design

  • Database design, validation and user acceptance testing

  • Edit check programming and testing

  • Data review and cleaning

  • Data coding for adverse events, medical history and concomitant medications

  • External data import and reconciliation

  • SAE reconciliation

  • Custom status reports for during the life of the study.

Our processes are supported by:

  • Clinical Data Management Plan

  • Data Validation Checks

  • SAE Reconciliation Plan

  • External Data Transfer and Reconciliation Plan

  • Database Lock Checklist.

Our goal is to shorten the data management set up and delivery timelines, whilst maintaining data integrity by using systems and processes that are compliant with global regulatory requirements, including the ICH guidelines and 21 CFR Part 11.​

 

Biostatistics

At Resolutum Global, our biostatisticians are engaged through the life of the project from study design to finalization of the clinical study report. We can also provide consulting services based on your project's requirements.

During the study design phase, our biostatisticians can provide input on the following areas:

  • Study design elements

  • Selection of the patient populations

  • Identification of study endpoints and statistical analysis methods

  • Sample size calculations

  • Study randomisations.

During the project, our biostatisticians provide the following services:

  • Development of the statistical analysis plans (SAP) and output shells

  • Provide data and analysis to support DSMBs, Data Monitoring or Safety Review Committee Meetings, Development Safety Update Report and interim analyses

  • Statistical analysis and review of all statistical deliverables

  • Ad hoc, post hoc and exploratory analyses.

  • Development of the statistical report and/or input to the clinical study report.

 

Statistical Programming

At Resolutum Global, our statistical programming team provides customized programming solutions using the industry standard software, SAS®.

Programming activities commence after the finalization of the statistical analysis plan to ensure that we are able to provide results shortly after database lock. Our goal is to deliver tables, listing and figures within two weeks after database lock.

All of our statistical programmers have vast experience producing tables, listing and figures for various different therapeutic areas, study designs and study phases. Our team is experienced in implementing CDISC standards and can produce fully compliant SDTM and ADaM data packages that meet all of the requirements for electronic data submissions to regulatory authorities.

We provide the following services:

  • Tables, Listings and Figures for any report type

  • Exploratory and post hoc analyses including the pooling of multiple study databases

  • CDISC packages:

    • SDTM: Annotated CRFs, domain-level SAS® datasets and a define.xml including the Study Data Reviewer's Guide.

    • ADaM: Analysis-level SAS® datasets and a define.xml including the Analysis Data Reviewer’s Guide.

  • Legacy study data conversions to CDISC standards

  • Outputs to support DSMBs, Data Monitoring or Safety Review Committee Meetings, Development Safety Update Report and interim analyses.

 

Medical Writing

The Resolutum Global medical writing team has experience engaging with the sponsor from protocol synopsis writing to compiling the appendices for the final Clinical Study Report across a broad range of therapeutic areas in early phase trials.

 We provide the following services; 

  • Protocol review or development

  • Protocol amendments

  • Investigator Brochure development

  • Patient Informed Consent Forms and patient information leaflets

  • Clinical Study Reports (interim, abbreviated, full or synopsis)

  • Subject safety narratives.