Clinical Trial Services

We provide comprehensive consulting services in essential aspects of psychiatric clinical research. Our expertise spans a number of treatments, indications, scientific approaches.

We offer a range of clinical trial services in the area of psychiatric drug development, neuroscience, and mental health, including studies of medical devices. We bring a wealth of experience to the specific requirements of conducting high-quality research in the challenging area of mental health. Our approach involves close collaboration with academic institutions and engagement of Key Opinion Leaders at UK Universities, whilst conducting clinical trials to high commercial standards. This allows us to both leverage cutting-edge academic research science and meet the quality and regulatory requirements of our clients.

Our services cover all essential aspects of clinical research including study design, clinical study management, and monitoring. We also have specialized expertise in the development and validation of biomarkers.

Study design services

• Literature searches and reviews
• Protocol writing
• Sample size calculations and power analyses
• Randomisation scheduling
• Statistical analysis consultation and SAP writing

Clinical study management

• Data and database management
• Site feasibility assessments, selection, and initiation
• Site management
• Recruitment management
• Clinical monitoring
• Study closeout
• Data analysis, including creation and validation of datasets, tables, and listings
• Clinical study report preparation
• Expertise in conducting both drug intervention studies and medical device trials

Biomarker development and validation

• Cognitive and imaging (e.g. MRI) biomarker development in consultation with experts from industry and academia
• Machine learning and big data approaches
• Software built to commercial regulatory standards
• Validation studies in healthy populations and target indications

DISEASE AREA	SIGN or SYMPTOM	CONSTRUCT	PARADIGM / TASK
Depression	Depressed mood	Attentional bias to negative information; visual perception; declarative memory; cognitive control; social communication	ETB tasks (e.g. Emotional Categorization, Emotional Memory, Facial Expression Recognition; Faces Dot Probe).    Emotional fMRI (e.g. Facial Emotion Processing; Emotional Counting Stroop; Emotional Encoding)
Depression	Depressed mood, Decreased interest or pleasure (anhedonia)	Initial Responsiveness to Reward Attainment	Monetary Incentive Delay task (neuro-cognitive fMRI; blunted response to reward)
Anxiety, Depression	Anxiety	Acute threat (fear) and Arousal	CO2 challenge and Emotion Potentiated Startle
Alzheimer’s Disease (and other forms of Dementia)	Cognitive deficiets; Memory loss	Declarative memory	Arena Virtual Maze (behavioural or neuro-cognitive with fMRI)
Schizophrenia (/schizotypy), Dementia	Cognitive impairment	Working memory	N-back task
Schizophrenia (/schizotypy)	Hallucinations, delusions	Auditory Perception	Signal Detection Task (see also Schizotypy Model)
Schizophrenia (/schizotypy)	Negative symptoms of Schizophrenia	Expectancy	Monetary Incentive Delay task (neuro-cognitive fMRI; blunted anticipation of reward)
Obesity	Over-eating	Satiety	Universal Eating Monitor
Various, including Depression, Schizotypy and Dementia	Cognitive Impairment	Reward Learning; Habit	Reversal Learning Task

Drug targets

The drug studies in our clinical studies have included:

• Adenosine receptors
• Cannabinoid receptors
• Dopamine receptors
• GABA receptors
• Glutamate receptors
• 5-HT receptors
• Neuropeptide receptors