Get a proposal

Therapeutic Expertise

Radiology / Medical Imaging

Our board-certified specialist radiologist brings a wealth of expertise in medical imaging modalities such as MRI, CT, PET, ultrasound, and functional imaging — ensuring accurate, timely data for clinical trials.

MRICTPETUltrasoundFluoroscopy

Pharmaceutical clinical trials involving sophisticated medical imaging endpoints are growing in number, as are radiology device and diagnostics trials.

We understand the importance of reliable image acquisition, interpretation, and centralised reading processes required to ensure the validity of imaging endpoints.

Addressing common pain points in radiology / medical imaging clinical trials

Patient recruitment and retention

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.

Radiology / Medical Imaging solution — Enhanced recruitment strategies

A patient-centric approach leveraging advanced data analytics and partnerships with healthcare institutions ensures faster recruitment and higher retention.

Data consistency and quality

Ensuring imaging data is consistently high quality across multiple sites, equipment, and operators is a challenge, especially in multi-centre trials.

Radiology / Medical Imaging solution — Advanced data management and quality control

Using AI-driven platforms and standardisation tools, we ensure imaging data is of the highest quality with minimised variability, irrespective of collection site.

Regulatory and compliance hurdles

Imaging trials have strict regulatory requirements, especially around radiation exposure. Navigating these and ensuring continuous compliance can be challenging.

Radiology / Medical Imaging solution — Dedicated regulatory and compliance teams

Our team stays informed of the latest regulatory updates, ensuring streamlined navigation and continuous adherence to all compliance mandates.

Technological and protocol variability

Different sites may use various imaging equipment or protocols, introducing variability in the data.

Radiology / Medical Imaging solution — Standardised imaging protocols & technology harmonisation

We work closely with sites to implement standardised protocols and technology harmonisation for consistent data regardless of equipment.

Data management and storage

The sheer volume of imaging data generated can pose significant challenges in storage, transfer, and analysis.

Radiology / Medical Imaging solution — Advanced data management systems

Our data management platform ensures secure storage, seamless transfer, and efficient analysis of large imaging datasets.

Frequently asked questions

Radiology / Medical Imaging clinical trials — FAQs

Does iNGENū provide a central imaging reading room?
Yes — we operate an in-house Central Reading Room with independent, blinded review and endpoint adjudication to standardise imaging endpoints across sites.
Which imaging modalities and endpoints are supported?
CT, MRI, PET and other modalities, with standardised acquisition, quality control and reader training to ensure reliable, reproducible imaging endpoints.
How does imaging quality affect regulatory acceptance?
Consistent, well-documented imaging is critical to FDA/EMA acceptance; our processes are built to 21 CFR Part 11 with full audit trails.

The iNGENū CRO difference

Australian expertise, direct FDA submission

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.

“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”

Giles MossChief Executive Officer

Ready to discuss your Radiology / Medical Imaging clinical trial?

Talk to our team about how iNGENū CRO can accelerate your research.

Request a proposal