In addition, radiology device and diagnostics trials are fast-growing too. Our clinical team includes a board-certified specialist radiologist, who brings a wealth of expertise in using medical imaging research to assist with correct trial design and strategy. We understand the importance of reliable image acquisition, interpretation, and centralised reading processes required to ensure the validity of imaging endpoints.
Disciplined,
Cost-Efficient Execution
while maintaining the Highest Quality
Local Trials,
Global Approvals
Access FDA Regulatory Expertise
Our Clinical Team has over
120
years
of Combined Clinical Trial Experience
Problem:
It can be challenging to find and keep patients who meet the specific criteria for radiology and imaging studies, leading to delays and increased costs.
iNGENū CRO addresses this pain point with Enhanced Recruitment Strategies:
We employ a comprehensive patient-centric approach, leveraging advanced data analytics and partnerships with healthcare institutions, ensuring faster recruitment and higher retention rates tailored for imaging studies.
Problem:
Ensuring that imaging data is consistently of high quality across multiple sites, equipment, and operators is a challenge, especially in multi-centre trials.
iNGENū CRO addresses this pain point with Advanced Data Management and Quality Control Systems:
Using state-of-the-art AI-driven platforms and standardisation tools, iNGENū ensures that imaging data is of the highest quality, with minimised variability, irrespective of the collection site.
Problem:
Radiology and medical imaging trials have strict regulatory requirements, especially around radiation exposure. Navigating these regulations and ensuring continuous compliance can be challenging.
iNGENū CRO addresses this pain point with Dedicated Regulatory and Compliance Teams:
Our team consistently stays informed about the most recent regulatory updates and guidelines. With iNGENū, clients can be assured of streamlined regulatory navigation and continuous adherence to all compliance mandates.
Problem:
Different sites may use various imaging equipment or have different protocols for imaging, which can introduce variability in the data.
iNGENū CRO addresses this pain point with Standardised Imaging Protocols and Technology Harmonisation:
We work closely with trial sites to implement standardised imaging protocols and offer technology harmonisation solutions, ensuring consistent data regardless of the equipment or site.
Problem:
The sheer volume of imaging data generated can pose significant challenges in terms of storage, transfer, and analysis.
iNGENū CRO addresses this pain point with Advanced Data Management Systems:
Our state-of-the-art data management platform ensures secure storage, seamless transfer, and efficient analysis of large imaging datasets.
We uniquely combine Australian expertise with direct FDA submission capabilities.
iNGENū CRO takes a highly strategic approach to clinical research.
We provide sponsors with comprehensive trial capabilities.
We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have been very happy with all aspects of the management of the clinical trial.