At Asclepes Research, we provide Phase I-IV clinical trials (both inpatient & outpatient) with a focus on CNS studies.
We endeavor to provide customer service at a level beyond client expectations and exceed the minimum standards of federal and state regulations to safeguard research participants.
The Asclepes Advantage
Within the network sites can provide:
- Psychiatry (Adult & Adolescence/Pediatric)
- General Medicine (Internal, medicine cardiology, Neurology, Pain, Addiction, Immunology)
- Bio – Markers
- (PSG / EEG / qEEG)
- Imaging (PET, fMRI, sMRI, fcMRI)
- Pharmacology (PD/PK, CSF)
- Psych / Motor Scales
- Cognitive Testing
Beyond study conduct and site selection, ASCLEPES can provide:
- Protocol writing
- Research and Study Design including operationalization of methods
- Thought leaders and expert consultants
- Ancillary Services, if required: IRB, Protocol writing and design, Report writing (CSR), Monitoring, Project Management, Statistical Analysis and Data Management through affiliated companies.
Experience
More than 50 years of collective clinical research experience with expert physician investigators and research staff
Anil Sharma MD, MBA
Chief Operating Officer
- Over 15 years of clinical research experience
- Board Certified Psychiatry and Neurology
- UCLA-NIH trained Clinical Research Pharmacologist
- UCLA-NIH trained Translational Research
- More than 7 years of IRB/Regulatory experience as CEO & Medical Director, IRB Company, Inc. – AAHRPP
- Owner of Accredited Independent Central IRB
- More than 5 years of Academic research experience at UCLA
Mitali Wadekar MD, CIP
Medical Director ASCLEPES Research Centers
- Over 10 years of clinical research experience
- Board Certified Adult, Child and Adolescent Psychiatry
- More than 7 years of IRB/Regulatory experience as Associate Medical Director, IRB Company, Inc.
- AAHRPP Accredited Independent Central IRB
- More than 5 years of Academic research experience at UCLA
Elizabeth Zarate-Rowell, MD
Medical Director Alliance Research
- Board Certified Psychiatry and Neurology
- DEA License
- Extensive Rating scale experience
- Experience with Child and Adolescent psychiatry
- Over 15 years of clinical research experience
- Recognized community thought leader or aging and Dementia
- Experience with Anti-aging medicine and Research
Timothy Welke, MA
Chief Operating Officer / VP Clinical Operations
- Ran Major Phase I Unit for Global CRO
- Built and implemented research processes on a local and national basis
- Managed national and international groups for Global CRO
- Over 27 years of clinical research and management experience
- Multiple years of financial, forecasting and accounting experience
- Operational experience with early and late phase programs, including ratings and study design
ASCLEPES RESEARCH CENTERS (ARC) provides support services for both established clinical research sites, as well as, new research sites just starting out. ARC is comprised of wholly owned, network managed and affiliated sites.
ASCLEPES Research Centers provides standard site management services (one budget, contract and invoice), quick feasibility, GCP trained staff and investigators, regulatory start up, coordinated recruitment and Quality Assurance. What makes ASCLEPES different; Unlike a traditional SMO, as a Managed Network Organization (MNO), ASCLEPES provides expanded and continual training programs, management oversight and escalation points, harmonization on research policies and COG’s / SOP’s between sites, standardization of source, access to long standing relationships of study providers and consultants, dedicated and experienced ASCLEPES research staff at each site and a network of CNS/Primary Medicine sites all following the above operational guidelines. Regional and Corporate oversight and escalation of issues will also be provided.
How we differ from SMO
SERVICES
Asclepes Research Centers
Traditional SMO
SERVICES
Asclepes Research Centers
Traditional SMO
Study Identification
Centralized Administration
– Contract Negotiations
– Contracts
– Budget Negotiations
– Budgets
– Study Payments (AP)
– Receivables Management
– Regulatory Documents
– Regulatory Submission
– Standard Study Source
Subject Recruitment
Call Center
Recruiting Database
Recruiting Website
Social Media Platform
Ongoing Study Management
PI/Site General Training
Advanced Trials Training
Inter-rater Reliability Program
Staffing
On-site Embedded CRC
Technical Systems to Measure Key Performance Metrics
Harmonized SOP’s
Corporate Support
Diverse Network of Medical Consultants
Vendor Support
Escalation contact for sponsors / CRO’s
Quality Control Program – Local
Quality Assurance Program – Network
Internal IRB Assistance and Review
Therapeutic Areas
NEUROLOGY
Alzheimer’s Disease
Parkinson’s Disease
Restless Leg Syndrome
Fibromyalgia
Migraine
Insomnia
PSYCHIATRY
Anxiety Disorders
Depression
OCD
Eating Disorders
Bipolar Disorder
Alzheimer’s Disease
Parkinson’s Disease
Schizophrenia
Schizoaffective Disorder
ADHD & Learning Disorders
Post Traumatic Stress Disorder
Tardive Dyskinesia
Addiction Medicine
Autism Spectrum Disorders
Tic Disorder & Tourette Syndrome
OTHERS
Chronic Pain Syndromes
Smoking Cessation
Metabolic Syndrome
Healthy Volunteers