Rho has contributed CRO services in 50+ psychiatric disorder studies to date and our staff has over 125 total years’ experience with psychiatric disorders, including a psychiatrist on staff with 30+ years clinical research experience. We have experience in a wide range of indications, including:
- Bipolar disorder
- Seasonal affective disorder
- Childhood disorders including autism and autism spectrum disorders
We have extensive experience with a number of commonly used scales, including:
- Depression rating scales (HAM-D, MADRS, BDI)
- Suicide rating scales (C-SSRS, STS)
- Bipolar & schizophrenia scales (BPRS, YMRS, PANSS, SAPS/SANS)
- Quality of life scales (Q-LES-Q)
- Anxiety rating scales (e.g. HAM-A, STAI, Y-BOCS)
- Cognitive rating scales (ADAS-cog, BLS-D, MMSE)
- Rating scales for children (CBCL, SKAMP, CRS)
- Diagnostic scales (e.g., DIS, SCID, MINI)
A few key facts:
- We have a psychiatrist on staff with 35 years of clinical research experience, including a clinical focus on diagnosing and treating patients with severe depressive and anxiety disorders. He also led an antidepressant development and medical affairs group, responsible for phase 2-4 clinical trials as well as market support for two approved antidepressants.
- We have several project directors with recent and extensive experience in drug trials for psychiatric products.
- We have strong relationships with successful sites that will help you meet your enrollment goals. Rho has been awarded a number of studies based on references from sites.
- We have expertise managing Schedule II drugs.
- Rho has made significant contributions to several successful 505(b)(1) NDA submissions as well as recent experience on three 505(b)(2) submissions to the FDA Division of Anesthesia, Analgesia, and Addiction Products (DAAAP).
- Rho has published more than a dozen articles in the area of CNS in prestigious peer-reviewed journals, including The Journal of the American Medical Association (JAMA), The Lancet Neurology, The Journal of Pediatric Psychology, and The Journal of the Neuropsychological Society.
Rho's CRO Services
- Integrated product development
- Clinical operations and monitoring
- Project management
- Medical monitoring
- Product safety and pharmacovigilance
- Biostatistics and statistical programming
- Clinical data management
- Regulatory operations
- Data standards and CDISC
- Regulatory and medical writing
- Quality assurance