CNS, Psychiatry & Neurology
Dr. Vince Clinical Research (DVCR) has extensive experience in evaluating investigational products for psychiatric and neurologic indications. Over the past 25 years, investigators on our team have participated in hundreds of clinical studies for these indications across all phases of research. Our medical, scientific, clinical operations and project management teams possess a deep understanding of the unique procedures, assessments, patient populations and questionnaires associated with CNS clinical trials.
Capabilities
As a CRO with significant expertise in psychiatry and neurology, DVCR provides a full-service solution from protocol writing through CSR publishing for the following study types in both healthy volunteers and patient populations. We conduct the following studies at our physician-led Phase 1 clinical pharmacology unit and at our global network of strategic site partners:
- ï„‘First-in-Human (FIH):
- KSingle Ascending Dose (SAD) which may include:
- [Early QT/cardiac safety in partnership with Clario
- [Food Effect cohort
- KMultiple Ascending Dose (MAD) which may include:
- [Patient cohorts
- KCombined SAD/MAD which may include:
- [Patient cohorts
- ï„‘NDA-enabling clinical pharmacology studies:
- KDrug-Drug Interaction
- KThorough QT/QTc in partnership with Clario
- KFood Effect
- KBioavailability/Bioequivalence
- KPharmacokinetic/Pharmacodynamic
- KRenal Impairment
- KHepatic Impairment
- ï„‘Human Abuse Potential (HAP)/Human Abuse Liability (HAL)
- ï„‘Phase Ib/IIa Proof-of-Concept (POC)
- ï„‘Phase II multi-site patient trials
- ï„‘Analog classroom studies for ADHD
Click below to receive more information on how our CRO can support your upcoming CNS trial.
Many of these trial types involve procedures, assessments and questionnaires which are specific to CNS, psychiatry and neurology such as:
- ï„‘Visual Analog Scales (VAS)
- ï„‘Cerebrospinal fluid (CSF) sampling/Lumbar puncture
- ï„‘Polysomnography (PSG)
- ï„‘Electroencephalogram (EEG)
- ï„‘Columbia-Suicide Severity Rating Scale (C-SSRS)
- ï„‘Clinician-Administered Dissociative States Scale (CADSS)
- ï„‘Brief Psychiatric Rating Scale (BPRS)
- Modified Observer’s Assessment of Alertness/Sedation Scale (MOAA/S)
- ï„‘Hamilton Depression Rating Scale (HAM-D)
- ï„‘Montgomery-Asberg Depression Rating Scale (MADRS)
- ï„‘Positive and Negative Syndrome Scale (PANSS)
- Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
- ï„‘ADHD Ratings Scale (ADHD-RS)
- ï„‘Clinical Global Impressions (CGI)
- ï„‘Patient Health Questionnaire-9 (PHQ-9)
Click below to receive more information on how our CRO can support your upcoming CNS trial.
Indications
DVCR’s medical, scientific, clinical operations and project management teams have participated in CNS clinical trials across multiple psychiatric and neurologic indications. Additionally, for multi-site trials, DVCR has built a global network of strategic site partners who have vast experience enrolling patient populations such as:
Depression (TRD, MDD)
Bipolar disorder
Schizophrenia
ADHD (adult, pediatric)
Substance Use Disorders (SUD) & Addiction
Epilepsy
Alzheimer’s Disease/Dementia
Parkinson’s Disease
Indications
DVCR’s medical, scientific, clinical operations and project management teams have participated in CNS clinical trials across multiple psychiatric and neurologic indications. Additionally, for multi-site trials, DVCR has built a global network of strategic site partners who have vast experience enrolling patient populations such as:
Depression (TRD, MDD)
Bipolar disorder
ADHD (adult, pediatric)
Schizophrenia
Substance Use Disorders (SUD) & Addiction
Epilepsy
Alzheimer’s Disease/Dementia
Parkinson’s Disease
Indications
DVCR’s medical, scientific, clinical operations and project management teams have participated in CNS clinical trials across multiple psychiatric and neurologic indications. Additionally, for multi-site trials, DVCR has built a global network of strategic site partners who have vast experience enrolling patient populations such as:
Depression (TRD, MDD)
Bipolar disorder
ADHD (adult, pediatric)
Schizophrenia
Substance Use Disorders (SUD) & Addiction
Epilepsy
Alzheimer’s Disease/Dementia
Parkinson’s Disease
Meet Our Experts
DVCR prioritizes scientific and medical considerations over commercial interests and is therefore committed to having a research team who is familiar with the drug classes, mechanisms of action, patient populations, procedures and assessments specific to CNS clinical trials. The following members of our company are involved in the oversight, planning and day-to-day conduct of clinical studies:
Bradley D. Vince, DO
CEO & Chief Medical Officer
Bio
With 25 years of experience in the clinical research industry, Dr. Brad Vince has served as an Investigator in over 700 clinical trials and authored numerous scientific publications. He also has deep industry experience in government studies, including acting as Principal Investigator for various FDA and NIH trials. In addition to founding Vince & Associates Clinical Research in 2001 and serving as president for nearly two decades, Dr. Vince has consulted for sites, CROs and biopharmaceutical companies. He is well-known in the clinical research industry for his passion, energy and 24/7/365 availability.
Sheldon Preskorn, MD
Senior Vice President, Neuroscience
Bio
Dr. Preskorn is an academic physician, psychiatrist, clinical researcher, neuropsychopharmacologist and medical educator. He has worked with over 140 pharmaceutical, biotech, device and diagnostic companies and has worked on 16 successful New Drug Applications. His publications include over 500 medical papers, books and book chapters. Further, he has been cited in medical literature over 18,000 times. Dr. Preskorn has served as a consultant to the FDA, EMA and NIH and has lectured in 55 countries and at most medical schools in the US and throughout the world.
Lynn Webster, MD
Executive Vice President, Scientific Affairs
Bio
Korey Nevitt
Executive Director, Site Partnerships
Bio
Korey Nevitt, Executive Director of Site Partnerships, has been in clinical research for over two decades with robust experience in operations, commercial strategy and planning and global site partnerships. Korey is responsible for the growth and expansion of our strategically aligned site partners ensuring our multi-site studies are conducted by the most capable investigators that they are aligned with our commitment to speed, customer service and delivering the highest quality data possible to our biopharmaceutical clients.
Rose Gerringer
Ratings Manager
Meet Our Experts
DVCR prioritizes scientific and medical considerations over commercial interests and is therefore committed to having a research team who is familiar with the drug classes, mechanisms of action, patient populations, procedures and assessments specific to CNS clinical trials. The following members of our company are involved in the oversight, planning and day-to-day conduct of clinical studies:
Bradley D. Vince, DO
CEO & Chief Medical Officer
Bio
With 25 years of experience in the clinical research industry, Dr. Brad Vince has served as an Investigator in over 700 clinical trials and authored numerous scientific publications. He also has deep industry experience in government studies, including acting as Principal Investigator for various FDA and NIH trials. In addition to founding Vince & Associates Clinical Research in 2001 and serving as president for nearly two decades, Dr. Vince has consulted for sites, CROs and biopharmaceutical companies. He is well-known in the clinical research industry for his passion, energy and 24/7/365 availability.
Sheldon Preskorn, MD
Senior Vice President, Neuroscience
Bio
Dr. Preskorn is an academic physician, psychiatrist, clinical researcher, neuropsychopharmacologist and medical educator. He has worked with over 140 pharmaceutical, biotech, device and diagnostic companies and has worked on 16 successful New Drug Applications. His publications include over 500 medical papers, books and book chapters. Further, he has been cited in medical literature over 18,000 times. Dr. Preskorn has served as a consultant to the FDA, EMA and NIH and has lectured in 55 countries and at most medical schools in the US and throughout the world.
Lynn Webster, MD
Executive Vice President, Scientific Affairs
Bio
Korey Nevitt
Executive Director, Site Partnerships
Bio
Korey Nevitt, Executive Director of Site Partnerships, has been in clinical research for over two decades with robust experience in operations, commercial strategy and planning and global site partnerships. Korey is responsible for the growth and expansion of our strategically aligned site partners ensuring our multi-site studies are conducted by the most capable investigators that they are aligned with our commitment to speed, customer service and delivering the highest quality data possible to our biopharmaceutical clients.
Rose Gerringer
Ratings Manager
Meet Our Experts
DVCR prioritizes scientific and medical considerations over commercial interests and is therefore committed to having a research team who is familiar with the drug classes, mechanisms of action, patient populations, procedures and assessments specific to CNS clinical trials. The following members of our company are involved in the oversight, planning and day-to-day conduct of clinical studies:
Bradley D. Vince, DO
CEO & Chief Medical Officer
Bio
With 25 years of experience in the clinical research industry, Dr. Brad Vince has served as an Investigator in over 700 clinical trials and authored numerous scientific publications. He also has deep industry experience in government studies, including acting as Principal Investigator for various FDA and NIH trials. In addition to founding Vince & Associates Clinical Research in 2001 and serving as president for nearly two decades, Dr. Vince has consulted for sites, CROs and biopharmaceutical companies. He is well-known in the clinical research industry for his passion, energy and 24/7/365 availability.
Sheldon Preskorn, MD
Senior Vice President, Neuroscience
Bio
Dr. Preskorn is an academic physician, psychiatrist, clinical researcher, neuropsychopharmacologist and medical educator. He has worked with over 140 pharmaceutical, biotech, device and diagnostic companies and has worked on 16 successful New Drug Applications. His publications include over 500 medical papers, books and book chapters. Further, he has been cited in medical literature over 18,000 times. Dr. Preskorn has served as a consultant to the FDA, EMA and NIH and has lectured in 55 countries and at most medical schools in the US and throughout the world.
Lynn Webster, MD
Executive Vice President, Scientific Affairs
Bio
Korey Nevitt
Executive Director, Site Partnerships
Bio
Korey Nevitt, Executive Director of Site Partnerships, has been in clinical research for over two decades with robust experience in operations, commercial strategy and planning and global site partnerships. Korey is responsible for the growth and expansion of our strategically aligned site partners ensuring our multi-site studies are conducted by the most capable investigators that they are aligned with our commitment to speed, customer service and delivering the highest quality data possible to our biopharmaceutical clients.
Rose Gerringer
Ratings Manager
