Psychiatry
Our team is adept at ensuring data quality in these complex scenarios, utilising expert psychiatric evaluators and advanced data capture technologies.
Mental health clinical trials pose challenges from multiple perspectives. A CRO must ensure that it has the requisite skills to allow recruitment of the correct population, minimise placebo effects, standardise (subjective) rating scales, and ensure patient safety. We help design studies that consider the unique nature of psychiatric assessments, which often rely on patient-reported outcomes and observer ratings. Strategies to minimise placebo effect and neurobehavioural biases are always built into all our mental health trials.
Our expertise extends to various conditions, including:
- Depression
- Anxiety Disorders
- Schizophrenia
- Bipolar Disorder
- Psychedelic Clinical Trials, where we are considered global leaders
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
Psychiatry Clinical Trial Resources
ADHD
Bridging the Past and Future of Treatment Strategies. From pivotal endpoints to enhancing trial success.
Bipolar Disorder
Read our whitepaper on epidemiology, clinical implications, and strategies for clinical trial success.
Schizophrenia
Evolving Insights into Schizophrenia Diagnosis and Treatments. Understanding clinical trial strategies.
Binge Eating Disorder
Optimizing clinical trial design for Binge Eating Disorder.
Panic Disorder
Explore insights into Panic Disorder clinical trial design, from FDA approvals to improved protocols.
Addressing Common Pain Points Associated with Psychiatry Clinical Trials
Subjectivity of Assessments
Problem:
Many psychiatric symptoms are self-reported, leading to potential biases and variability in data.
iNGENū CRO addresses this pain point with Objective Biomarkers:
iNGENū CRO is at the forefront of developing and implementing objective biomarkers, such as advanced imaging techniques and blood-based diagnostics, to reduce reliance on subjective self-reports and improve the accuracy of psychiatric disorder assessments.
Heterogeneity of Disorders
Problem:
There’s often a wide range of symptoms within a single diagnosis, making it challenging to assess treatment effects across a broad patient population.
iNGENū CRO addresses this pain point with Stratified and Personalised Medicine:
iNGENū CRO employs advanced patient stratification techniques to identify specific subtypes within psychiatric disorders, allowing for targeted therapeutic interventions that lead to more precise and meaningful clinical outcomes.
Placebo Effect
Problem:
Psychiatric trials frequently experience strong placebo responses, making it difficult to demonstrate the true efficacy of an investigational treatment.
iNGENū CRO addresses this pain point with Adaptive Trial Designs:
To counteract placebo effects, iNGENū CRO utilises adaptive trial designs that allow real-time modifications based on interim data. These designs enhance trial efficiency while improving the ability to detect genuine treatment responses.
Recruitment Challenges
Problem:
Psychiatric studies often face recruitment and retention difficulties due to stigma, symptom severity, or concerns about experimental treatments.
iNGENū CRO addresses this pain point with Patient Engagement Strategies:
iNGENū CRO collaborates closely with patient advocacy groups, integrates digital recruitment methods, and offers decentralised trial options to improve accessibility, enhance patient comfort, and optimise retention rates.
Ethical Concerns
Problem:
Balancing the risks and benefits of psychiatric trials – particularly for vulnerable populations or novel therapies – can be complex.
iNGENū CRO addresses this pain point with Rigorous Ethical Framework & Patient-Centric Approach:
iNGENū CRO ensures strict adherence to ethical guidelines, working closely with ethics committees and implementing patient-centric methodologies to protect participant wellbeing while facilitating scientific progress.
The iNGENū CRO Difference
Local Trials, Global Approvals
We uniquely combine Australian expertise with direct FDA submission capabilities.
Disciplined, Cost-Efficient Execution
iNGENū CRO takes a highly strategic approach to clinical research.
Australian-Headquartered, Asia-Pacific Reach
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.
Ready to discuss your Psychiatry Clinical Trial?