Full CRO service
Performing at the highest levels to deliver quality results in the most timely and efficient manner.
Complicance
About
Resonance Clinical
Fully conversant with the FDA, CE and TGA regulatory requirements.
Trusted by
Successful clinical trials require experienced operational teams that work together efficiently in a timely matter. Resonance Clinical’s full service CRO solution does exactly that.
Bethany Tippett
Resonance Clinical
Creating breakthroughs since 2005
Capabilities
Resonance Clinical offers a broad capability from the provision of standalone diagnostic imaging and central laboratory analysis to a fully integrated clinical trial research service. Since our inception in 2005, we have provided compliant, timely, secure and accurate clinical reports to our pharmaceutical, biotech and academic partners in over 100 clinical trials worldwide.
Clinical operations
Our clinical operations teams combine the scientific aspects of clinical research with business management, ensuring your clinical trial is executed efficiently, following the highest standards and achieves regulatory approval.
Data management
Our clinical data management team uses a range of validated clinical data systems to ensure overall safety and success in a timely and cost-effective way. Our team is experienced in all disciplines related to managing data, including collecting, processing, governing, sharing and analysing data.
Biostatistics
Our biostatistics team is involved throughout all stages of the trial process, from designing the protocol and case report forms, and planning the analyses to analysing and preparing interim and final clinical trial reports.
Safety
Our safety review committee and pharmacovigilance division understand the importance of safety throughout the clinical trial process in order to achieve regulatory approval. From the SAE setup and management to the annual DSUR submission, safety is ensured throughout the clinical trial.
Regulatory affairs
The Resonance Clinical team are experienced regulatory professionals. We assist pharmaceutical, medical device and healthcare companies with bringing products to market. Resonance Clinical utilises regulatory cleared medical devices to provide its analysis services. We are ISO 13485:2016 certified and comply with Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Part 820 (Quality System Regulation – QSR), International Centre for Harmonisation (ICH E6(R2)) standards on Good Clinical Practice (GCP), ISO 17025:2017 (Testing and Calibration Laboratories), National Association of Testing Authorities (NATA), Organisation for Economic Co-operation and Development (OECD) standard on Good Laboratory Practice (GLP), AHPRA registration for medical personnel providing trial services.
We are also compliant with the following Privacy Acts and Regulations: HIPAA (US), HITEC Acts (US), GDPR (EU) and the Privacy Act (AU).
Quality assurance
Ensuring participant safety and data integrity is critical in any clinical trial. Resonance Clinical provides a full range of independent quality assurance services throughout the clinical trial process. Our quality assurance team conducts ongoing audits for all critical vendors to ensure compliance with high standards.
Medical affairs and communications
Our expert communications team works together with clinical professionals to ensure the right messages are delivered to different audiences. We provide high-quality documentation and communication at all stages of the clinical trial process: from study design, protocols, and regulatory submissions to clinical study reports and scientific publications. Our communication team liaises with key opinion leaders and we provide their feedback at every stage of product development.
Our therapeutic areas
We focus on iron overload disorders, metabolic and liver-related disorders and brain diseases.