Our Proven Methodologies Give You Maximum Confidence
Proven Methodologies: We have Designed and Helped Implement Protocols for over 100 Trials, and Counting
Our study methodologies enhance signal detection and reduce sample size. Innovative protocol designs reduce the impact of placebo effect, measure novel outcomes to enhance signal detection, precisely assess side effect profiles, and exploit peripheral and neuroimaging biomarkers.
Maximum Confidence: Our Proof of Concept Trial Designs Span All Investigative Areas
Our extensive experience designing POC protocols extends to all CNS areas, including major depressive disorder, treatment resistant depression, post-traumatic stress disorder, obsessive compulsive disorder, ADHD, schizophrenia, bipolar disorder and women’s mental health.
SAFER Remote Interviews Ensure Best-Fit Patients For Your Trials
Our remote raters are rigorously trained, experienced psychiatrists and psychologists with real-world research and clinical experience. They are highly qualified to ensure best-fit patients are enrolled in your trial. We use the SAFER methodology in interviews to verify diagnoses and the appropriateness of the patient sample, and verify severity of illness and treatment history to match your requirements and study parameters. An internal review process is available to determine enrollment status in complex situations.
Keeping Excellence in "Site" at Every Step
Trial-Specific Training for Site Raters Is Key
Well-trained site raters are crucial to success. We develop training programs on a trial-specific basis and load them into our custom-built Learning Management System. Training covers all study scales, includes recorded mock interviews and skill demonstrations. Available to investigators in the U.S. Japan, Europe, South Africa, and South America.
Our Site Selection Database Drives High Trial Quality
We assess and recommend only the highest-quality sites that meet your strict demands. We maintain performance metrics on 250+ U.S. and hundreds of global sites, so we can fill specific needs, such as identification of sites with experience in specific indications, the ability to use a central IRB, skill level sufficient to start up a study, recruitment success, and much more.
Clinical Medical Monitoring by Board Certified Psychiatrists Ensures Safety and Integrity
We provide medical review and management of clinical trial activities, collaborating with site principal investigators and the sponsor to ensure patient safety and trial integrity. Our Medical Monitors are board certified psychiatrists with an average of over 10 years clinical trial experience as principal investigators of NIH funded trials and site investigators for industry trials. Our Medical Monitors also have many years of clinical experience in the treatment of patients with psychiatric disorders.
Staff Your Scientific Advisory Boards and Consultations with Internationally Recognized Experts
MGH provides access to highly experienced researchers who are recognized world leaders in many areas of psychiatric research, including anxiety, depression, bipolar disorder, women’s mental health, schizophrenia, geriatrics/ Alzheimer’s disease, pharmacogenetics, neuroimaging, OCD, ADHD, PTSD, and pediatric psychopharmacology. Our long-standing relationships with investigators from many institutions enables us to set up knowledgeable, top-flight Scientific Advisory Boards to review of Clinical Development Plans, POC trial designs, and compound libraries.
