Gynaecology

Conducting clinical trials in gynaecology demands deep sensitivity to patient needs, comprehensive understanding of women's health issues, and a precise approach to hormonal and reproductive biology.

Gynaecology clinical trials often involve addressing conditions that significantly impact quality of life and require patient-centred methodologies to ensure comfort, compliance, and accurate data collection. iNGENū CRO provides high-quality, patient-centric solutions that address these unique challenges effectively and efficiently.

Common Gynaecology indications in which we have experience include:
  • Endometriosis
  • Uterine fibroids
  • Polycystic Ovary Syndrome (PCOS)
  • Menopause and hormonal therapies

We engage deeply with women's health specialists, advocacy groups, and patient communities to design and implement studies that are scientifically rigorous yet sensitive to participant experiences.

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 Gynaecology Clinical Trials 

Recruiting patients for sensitive gynaecological conditions can be challenging.

iNGENū CRO addresses this pain point with Tailored Recruitment Strategies

We employ sensitive, patient-centric recruitment approaches, including partnerships with women's health clinics and advocacy groups, and telemedicine platforms to ensure comfort and engagement.

Gynaecological conditions often rely on patient-reported outcomes (PROs), which can introduce variability.

iNGENū addresses this pain point with Standardised PRO Tools

We implement validated, standardised PRO instruments and provide thorough training to clinical staff, ensuring consistency and accuracy in data collection.

Strong placebo effects can complicate the interpretation of trial results in hormonal treatments.

iNGENū addresses this pain point with Robust Blinding Methods

We design trials with rigorous blinding procedures and use advanced statistical analyses to account for placebo responses.

Hormonal treatments require vigilant safety monitoring for potential adverse effects.

iNGENū addresses this pain point with Comprehensive Safety Protocols

We utilise advanced monitoring systems and real-time safety reviews to promptly identify and manage adverse events, prioritizing patient well-being.

Gynaecology Clinical Trial Resources

Menopausal Insomnia Clinical Trials_ Overcoming Barriers in Endpoints and Safety to Improve Outcomes

Menopausal Insomnia

Overcoming Barriers in Endpoints and Safety to Improve Outcomes in Menopausal Insomnia Clinical Trials

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

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