RISE Institute · Consulting Services

Psychiatric Research & Development Consulting

RISE Institute offers specialized consulting services for organizations engaged in psychiatric drug development, clinical program design, and mental health research. Our team brings together world-leading expertise in mood disorders, psychopharmacology, and clinical trial methodology.

Our Approach

Science-Led. Clinically Grounded.

Our consultants are active researchers and clinicians with deep expertise across the full spectrum of psychiatric drug development — from early-phase study design through regulatory submission and interpretation of results.

We bring the scientific rigour of academic medicine together with the practical experience of clinical trial conduct, offering clients a rare combination of thought leadership and operational insight.

Who We Work With

Pharmaceutical and biotechnology sponsors developing CNS and psychiatric therapeutics
Academic institutions and research networks seeking scientific advisory support
Investment and venture firms requiring clinical and scientific due diligence
Healthcare organizations developing mental health programs and clinical pathways

Consulting Services

Our consulting engagements are tailored to each client's program and objectives. Core service areas include:

01
Clinical Development Strategy
End-to-end advisory support for psychiatric drug development programs, including indication selection, regulatory pathway planning, and go/no-go decision frameworks.
02
Protocol Design & Review
Scientific review and optimization of clinical trial protocols, including endpoint selection, outcome measure validation, and patient population definition for psychiatric indications.
03
Scientific & Medical Advisory
Strategic advisory board participation, regulatory meeting preparation (pre-IND, pre-CTA, Type B/C meetings), and scientific positioning for mood disorder and CNS programs.
04
Data Interpretation & Analysis
Expert review and clinical interpretation of trial results, biomarker data, and efficacy and safety outcomes in the context of current psychiatric research standards.
05
Due Diligence Support
Independent scientific assessment of psychiatric drug candidates, clinical data packages, and pipeline assets for licensing, acquisition, or investment purposes.
06
Medical Education & Publication
Development of scientific communications, clinical practice guidelines, continuing medical education content, and peer-reviewed publications in psychiatry and psychopharmacology.

Global Recognition

Our lead consultant is among the world's most cited researchers in psychiatry, recognized by Clarivate Analytics as one of "The World's Most Influential Scientific Minds."

Active Clinical Researchers

Our team conducts ongoing clinical research in mood disorders, treatment-resistant depression, and psychopharmacology — ensuring advice grounded in current evidence.

Regulatory Experience

Direct experience contributing to CANMAT, Florida Best Practice, and international clinical practice guidelines for the treatment of major depressive and bipolar disorders.

Meet the Team

Our consulting practice is led by internationally recognized experts in psychiatric research, clinical pharmacology, and mood disorder treatment.

Dr. Roger S. McIntyre
Lead Consultant

Dr. Roger S. McIntyre

MD, FRCPC

Professor of Psychiatry & Pharmacology, University of Toronto · Executive Director, Brain and Cognition Discovery Foundation

Dr. Roger S. McIntyre is one of the world's foremost authorities in mood disorders and psychopharmacology. He has authored or co-authored more than 1,000 peer-reviewed articles and has edited several textbooks on mood disorders. His research focuses on the phenomenology, neurobiology, and novel therapeutics of major depressive disorder and bipolar disorder, with particular emphasis on cognitive function and medical comorbidity.

Dr. McIntyre completed his medical degree at Dalhousie University and received his psychiatry residency training and Fellowship in Psychiatric Pharmacology at the University of Toronto. He is the lead author of the Florida Best Practice Psychotherapeutic Medication Guidelines for Adults with MDD and Bipolar Disorder, the International Expert Opinion on Ketamine and Esketamine in Mood Disorders, and a contributor to the CANMAT guidelines for the treatment of depressive and bipolar disorders.

Named one of "The World's Most Influential Scientific Minds" by Clarivate Analytics — 2014 through 2023
HG

Dr. Hartej Gill

PhD

University of Toronto

Dr. Hartej Gill is a researcher with over 100 publications and book chapters spanning various topics in psychiatry and neuroscience. With 10 years of experience and publications in top psychiatric journals, Dr. Gill has extensive knowledge developing clinical protocols and best practices for clinical research.

His research contributions include investigations into ketamine for treatment-resistant depression, novel therapeutic approaches in major depressive disorder and bipolar disorders, cognitive dysfunction, and the application of GLP-1 receptor agonists in psychiatric populations.

Mood Disorders Ketamine & TRD Bipolar Disorder Neuroinflammation GLP-1 Anhedonia
MS

Dr. Margarita Shekotikhina

MD, FRCPC

Lecturer, Department of Psychiatry, University of Toronto · Staff Psychiatrist, Trillium Health Partners

Dr. Margarita Shekotikhina is a staff psychiatrist at Trillium Health Partners and Lecturer in the Department of Psychiatry at the University of Toronto. Her clinical practice spans emergency psychiatry, inpatient psychiatric care, and shared care models, with a subspecialty focus on IV ketamine for treatment-resistant mood disorders.

Dr. Shekotikhina completed her MD at Poznan University of Medical Sciences and her psychiatry residency at the University of Ottawa, where she served as chief resident. She is actively involved in clinical research with publications focused on treatment-resistant mood disorders and is committed to evidence-based, patient-centred psychiatric care.

Emergency Psychiatry Treatment-Resistant Depression IV Ketamine Inpatient Psychiatry

Inquire About a Consulting Engagement

To discuss how RISE Institute's consulting team can support your research or development program, please reach out to us directly. We welcome inquiries from sponsors, academic institutions, and healthcare organizations.

Get in Touch