Psychiatry CRO

Extensive Experience and Comprehensive Services for Psychiatric Clinical Development

Developing medical therapeutics for psychiatric diseases requires a specialized CRO partner. Lotus brings extensive experience, scientific acumen, comprehensive services including rater training and Placebo Response Mitigation, and access to investigational sites with exceptional psychiatric expertise. From early phase through phase IV, Lotus can help accelerate your psychiatric clinical development.

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Psychiatry Studies

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Schizophrenia and Depression Studies

Portfolio Sites with Psychiatric Expertise

Note: Statistics combine experience from both Lotus Clinical Research and Evolution Research Group’s network of clinical research sites

Demonstrated Expertise in Key Indications

ADHD
Anxiety Disorders
Bipolar Disorder
Eating Disorders
Depressive Disorders
Obsessive Compulsive Disorder
Opioid Use Disorder
Post-Traumatic Stress Disorder
Schizoaffective Disorder
Schizophrenia
Sleep Disorders as a secondary endpoint

Independent ratings and independent quality reviews can mitigate the risks of bias, variability, and human error.

Improve data quality

Maximize signal detection

Reduce variability

Ensure consistency

Specialized Services and Training to Support Psychiatric Clinical Research

Clinical Rating Scales and Screening Tools

Our expertise with clinical rating scales and screening tools allows us to accurately assess and evaluate patient responses and outcomes during clinical trials.

Global Rater Training & Certification

Consistency and reliability in assessments is critical to the success of psychiatric trials. Our rater training programs go beyond the usual technical “how to” approach. We assist raters in understanding the underlying rationale and rating conventions of each rating scale in a manner that is proven to maximize inter-rater reliability across raters, studies, and cultures.

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Placebo Response Mitigation (PRM)

Carefully designed to reduce variability and placebo response without diminishing treatment response, Lotus’ proprietary PRM program has become the industry standard and the most widely deployed program of its kind.

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Adjudication and Surveillance Services

Our team provides adjudication and surveillance services, ensuring the integrity and quality of your clinical trial data. We maintain a vigilant approach to uphold the highest standards throughout the research process.

Ensuring Data Quality in Psychiatric Clinical Studies

Rater Qualification

Analysis of rater education and experience to ensure qualified raters train on scales.

Rater Training

Conceptual knowledge via didactic training.

Rater Certification

Raters are calibrated via gold-star standard scoring criterion for all key inclusion and efficacy scales.

Adjudication

Centralized review of study data and baseline rating scales to ensure proper subjects are enrolled in trials to prevent rate inflation and other errors.

Surveillance

Centralized review of rater data throughout study to prevent rater inflation and enhance quality of ratings.

Recalibration

Recertification on standardized scores during the course of long trials to ensure continued inter-rater reliability.

The Lotus-ERG Advantage in Psychiatric Studies

For US-based studies, Lotus is able to leverage its affiliation with ERG, providing access to experienced sites and Principal Investigators in psychiatric clinical development. At ERG, raters average 20 years of clinical experience and are certified by industry-recognized psychiatric rating experts while back-up raters provide consistency across studies. Critically, both raters and site staff receive extensive training on mitigating placebo response which augments sponsor-provided instruction.

Specialized Equipment and Staff Expertise for Psychiatric Research Studies

ERG sites have access to a full suite of neuroimaging for psychiatric studies as well as other testing, services, and expertise including:

Functional magnetic resonance imaging (fMRI)
Magnetic resonance imaging (MRI)
Positron emission tomography (PET) scans
On-site Polysomnogram (PSG) equipment, enabling overnight sleep studies without needing to disrupt patients.
Electroencephalography/quantitative electroencephalography (EEG EEG/qEEG) experience
Other specialized testing such as ophthalmologic exams, gynecological procedures, and surgical implants
On-site staff prepare investigational products for all routes of administration, including compounding, encapsulation, and IV infusion. Sites engage in regular mock dosing to ensure that all time points are met, including pharmacokinetics (PK)
Rigorous quality reviews are conducted by full-time quality assurance and quality control staff to ensure optimal outcomes for your study—and ample inpatient beds to accommodate complex study designs and provide the flexibility to separate populations

Targeted Patient Recruitment

The target patient population for psychiatric clinical trials is often misdiagnosed—or even undiagnosed—making these trials challenging to recruit, manage and assess. Sponsors then frequently seek specific traits, from age and gender to BMI or symptomatology. ERG’s signature patient strategies include sophisticated patient recruitment and retention practices deployed across the entire site network. They begin with large patient databases and local partnerships, then carefully prescreen, screen and enroll to gather the optimal patient cohort for your trial.

In a recent rescue study of a schizophrenia therapy, ERG completed study start-up (contracting, regulatory and site initiation) in 48 hours—and was the top-enrolling site in the study.