Infectious Diseases

At iNGENū CRO, our team brings extensive expertise in infectious disease research, offering high-quality, flexible, and accelerated solutions tailored to meet the dynamic needs of global sponsors.

Conducting clinical trials in infectious diseases requires an in-depth understanding of rapidly evolving pathogens, complex patient management, strict infection control measures, and the ability to respond swiftly to emerging threats.

We collaborate closely with infectious disease specialists and maintain strong partnerships with clinical sites globally to ensure rapid mobilisation and execution of trials.

Our clinical team has substantial experience across a broad spectrum of infectious conditions, including:
  • Viral Infections (COVID-19, Hepatitis B & C, HIV)
  • Bacterial Infections (Tuberculosis, MRSA)
  • Fungal Infections (Candidiasis, Aspergillosis)
  • Parasitic Diseases (Malaria, Leishmaniasis)
  • Vaccine Development and Evaluation
  • Antimicrobial Resistance

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

Addressing Common Pain Points Associated with Infectious Disease Clinical Trials 

Clinical trials in infectious diseases necessitate stringent biosafety measures to protect patients, staff, and communities.

iNGENū addresses this pain point with Rigorous Biosafety Protocols

Our team implements comprehensive infection control protocols aligned with global biosafety standards. We provide thorough training and continuous monitoring across all sites, ensuring the highest safety measures are consistently maintained throughout the trial.

Regulatory landscapes can rapidly change during infectious disease outbreaks, complicating trial design and execution.

iNGENū addresses this pain point with Expert Regulatory Navigation

Our regulatory experts possess deep knowledge of global and regional requirements for infectious disease trials. We provide agile and proactive regulatory support, ensuring compliance and facilitating timely approvals even amidst rapidly changing guidelines.

Infectious diseases often involve multifaceted outcome measures, including viral load, immune response, and clinical endpoints, complicating data collection and analysis.

iNGENū addresses this pain point with Comprehensive Outcome Assessment

We integrate robust methodologies for both clinical and laboratory outcome assessments. Our experienced clinical team and centralised laboratories ensure standardised, accurate, and timely data collection and analysis, simplifying complex trial outcomes.

Infectious disease outbreaks often require rapid response times, making swift patient recruitment and site activation critical.

iNGENū CRO addresses this pain point with Accelerated Recruitment and Activation

We maintain a global network of pre-qualified clinical sites with rapid start-up capabilities. Our advanced patient databases and strategic partnerships with infectious disease centres enable us to identify and enroll eligible patients quickly, ensuring timely trial initiation.

Trials involving novel therapies or vaccines for infectious diseases carry inherent safety risks that require vigilant monitoring and rapid response capabilities.

iNGENū addresses this pain point with Enhanced Safety Monitoring

We employ advanced safety monitoring systems and real-time data analytics. Our dedicated safety board proactively reviews data to swiftly identify and manage potential adverse events, ensuring participant safety and maintaining trial integrity.

Infectious Diseases Clinical Trial Resources

Infectious Diseases - iNGENū CRO

HIV/AIDS

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Read our whitepaper

The iNGENū CRO Difference

iNGENu - FDA
Local Trials, Global Approvals

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

iNGENu - cost efficient
Disciplined, Cost-Efficient Execution

iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes. Our trials are designed with efficiency in mind, eliminating unnecessary costs while maintaining the highest scientific and regulatory standards.

iNGENu - APAC
Australian-Headquartered, Asia-Pacific Reach

We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless combination of cost-efficiency and high-quality clinical trials. We leverage the region's competitive pricing while maintaining rigorous Australian-based project management and clinical oversight.

"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.

We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."

Giles Moss
Chief Executive Officer

iNGENu testimonial-logos-monotone-1

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