clinical trial centers alliance...2016/10/17 · clinical trial centers alliance is a unique group...
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Clinical Trial Centers Alliance
offering specialized expertise to fit the unique needs of each client
Bobbie Theodore, M.S. Alliance Director
[email protected] www.alliancesites.com
The Alliance
Executive Summary
Site Locations
Staff Highlights
Capabilities
Therapeutic Areas
Recruitment and Retention
Advantages
Sample Metrics – Phase I-IIa
Sample Metrics – Phase II-IV
Curricula Vitae
Contact
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Table of Contents
www.alliancesites.com
The Alliance
Clinical Trial Centers Alliance is a unique group of specialty research clinics and gold standard service providers that share a sponsor relations team, best practices and the common goal of providing quality data and enrollment. We specialize in phase I-IV trial design, conduct and management to support a full clinical program.
Jeanette Caruso Bobbie Theodore Annie Speno Project Manager Alliance Director Operations Director
www.alliancesites.com
Executive Summary
Our Alliance can address all stages of clinical research activities. We propose flexible options to serve your needs as follows:
A menu of services under one liaison
Expertise across a range of therapeutic areas, phase I through post-marketing
Integrated services including clinical site conduct, with or without bundled vendor or CRO services such as protocol development, trial management, data management, statistical analysis, monitoring, rater training, translations – any or all to meet your clinical program needs Central IRB Large patient databases, affiliated medical practices and proven recruitment and retention methods
Click links below to download fact sheets for each of our sites and services: Collaborative Neuroscience Network, LLC., Phase I Unit—Long Beach, CA Collaborative Neuroscience Network, LLC.—Torrance & Garden Grove CA Pacific Research Partners, LLC.—Oakland, CA Oregon Center for Clinical Investigations, Inc.—Portland & Salem, OR Clinical Trials of the Rockies—Denver, CO Albuquerque Neuroscience, Inc.—Albuquerque, NM FutureSearch Trials of Neurology and Sleep Medicine, L.P.—Austin, TX FutureSearch Trials of Dallas, L.P.—Dallas, TX Synapse Clinical Research, LLC.—Durham, Hillsborough, & Pinehurst, NC Hassman Research Institute, LLC. — Berlin, NJ
www.alliancesites.com
Site Staff Highlights
Full-Time Dedicated And Highly Experienced Staff
Investigators are Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Addiction Medicine, Endocrinology, Pulmonology, and Licensed Clinical Psychologists
Protocol consultants to sponsors and CROs, and experts in psychiatry, cognition, neurology, addictions and phase I study designs
Full-time certified, psychometric clinical raters – doctorate and M.A.-level with up to 20+ years rating experience
Multiple full-time study coordinators including CCRCs, RNs, and LVNs
Dedicated recruitment and outreach specialists with established referral networks in their communities
Regulatory, QA, training and IT personnel
www.alliancesites.com
Site Capabilities
Specialized Capabilities and Experience
State-of-the-art Clinical Pharmacology Units (CPU) CNS Biomarkers:
EEG and qEEG with evoked potentials Imaging, 1.5 and 3T MRI, PET and fMRI Lumbar puncture and CSF collection Occular Assessments Psychomotor Testing
Human Abuse Liability and Hepatic and Renal Impairment Units 24 hour monitoring – cardiac, and PSG (polysomnography) Serial PK and ECG Compounding drug Infusion, injection, oral, sublingual, device, implant and transdermal patch delivery systems Software / Neurogaming Product Validation
www.alliancesites.com
Therapeutic Areas Psychiatry Phase I-IV
Abuse liability/deterrent (HAL)
Addictions – smoking cessation, alcohol dependence, binge eating, opioid, drug
ADHD – adult and child, including analog classroom, adult workplace
Anxiety – GAD, PTSD, OCD
Bipolar – bipolar depression, mania, mixed
Cognition and cognitive impairment
Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction
Schizophrenia and schizoaffective disorders – acute, stable, cognitive dysfunction, negative symptoms
General Medical Phase I-IV Asthma, COPD
Constipation and irritable bowel
Dermatology
Diabetes
Hypercholesterolemia
Hypertension
Nutraceuticals
Obesity
Ophthalmology
Vaccines
Women’s health
Special Patient Populations Healthy and healthy elderly Asian bridging
Renal and hepatic impaired
Pain Phase I-IV Acute and chronic pain
Fibromyalgia
Episodic and chronic migraine
Neuropathic pain
Osteoarthritis
Post herpetic neuralgia
Neurology Phase I-IV Alzheimer’s – MCI, prodromal, mild, moderate, and severe with agitation
Multiple Sclerosis – relapsing remitting
Parkinson’s – early stage to advanced
Post-stroke, movement disorders
Sleep– insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea, maintenance
www.alliancesites.com
Recruitment and Retention Recruitment
Full-time dedicated recruitment and outreach specialists on staff Extensive databases Affiliated Investigator private and group practices (psychiatry, neurology, family practice, sleep, endocrinology, ophthalmology, dermatology, gastroenterology, cardiology, urology and pain) Established relationships with physician networks for patient referrals Outreach to and relationships with residential facilities, board and cares, senior communities, Japanese communities Participation in community events and support groups – providing free seminars, lunch and learns History of successful advertising - traditional and social media Ability to pre-qualify patients via IRB-approved pre-screen consent form
Retention Modern inpatient facilities, some with private and semi-private rooms for caregivers Site-provided patient transportation Full-time dedicated staff for regular communication with patient, family and caregiver, reminder and follow-up phone calls Thorough pre-screening Treating physicians allow for ease in transition and follow-up
www.alliancesites.com
Alliance Advantages
Advantages and Expertise
Geographically and therapeutically diverse sites
Menu of site and study management services based on sponsor need
Responsiveness and ease of single point of contact for all
Dedicated regulatory, and budget and contract staff for quick turnaround
Central IRB of sponsor’s choice
Best clinical and operational practices shared across sites
Thought leaders in CNS and Phase I designs
Multiple publications and advisory board memberships
Established vendor relationships for seamless execution
Protocol and budget development and consulting
Proven separation data
www.alliancesites.com
Sample Metrics - Phase I & IIa Study Title # of Patients Contracted/Screened/Enrolled Year Status
A Phase IIa, Multiple Oral Doses , in Healthy Elderly Subjects (incl. 3 Lumbar Punctures)
Contracted for 30,
Screened 37, Enrolled 15 in 1 month, single site
2016 Closed
Phase I, Online Neurocognitive test battery, Normal healthy adults and healthy elderly
Contracted for 280 across 3 sites
Screened 250 , Enrolled 227 so far in 5 months, across 3 Alliance sites
2016 Enrolling
Phase I, OL, Multiple Dose, Chronic, Stable Schizophrenia or Schizoaffective Disorder
Contracted for 4 cohorts of 10 (40)
Screened 116, 60 patients plus back up subjects in 3 months, single site
2015 Closed
Phase I, Single and Multiple Rising Dose, Healthy Smokers
Contracted for 1 cohort of 5 and 2 cohorts of 8 (21)
Screened 50, Enrolled 21 in 3 ½ months, single site
2015 RESCUE SITE
Phase I, Single and Multiple Dose, Healthy Adult Japanese Subjects - Part I and II
Contracted for 2 cohorts of 8 (16)
Screened 36, Enrolled 16 in < 2 months over the holidays, single site
Nov-Dec 2014
Closed
Phase I, Escalating, Single-dose, Healthy, Male Subjects
Contracted for 5 cohorts of 12 (60)
Screened 110, Enrolled 60 plus back up subjects in 5 months, single site
2013
2014
Closed
Phase I, Single Oral Dose AND Ascending Multiple Oral Dose, Schizophrenia
Contracted for 7 cohorts of 15 (105)
Screened 128, Enrolled 93 plus back up subjects in 3 months, single site
2014 RESCUE SITE
Phase I, Single and Multiple Ascending Dose, Intravenous Infusions, Mild to Moderate Alzheimer’s Disease
Study design 5 cohorts; 1 pt/cohort from ea site
Screened 35, 20 patients enrolled (2 cohorts of 10 each) in 12 months, multi-site
2012
2013
TOP ENROLLER
Phase I, Major Depressive Disorder - (Extensive PKs & multiple ECGs)
Contracted for 38
Screened 38, Enrolled 22 in 6 weeks, across 2 Alliance sites
2011 TOP ENROLLER
www.alliancesites.com
Sample Metrics Phase II-IV Study Title
# of Patients Screened
# of Patients Randomized
Length of Enrollment Year Status
Phase III, Inpatient, antipsychotic efficacy, Schizophrenia 94 64 8 months 2016 Enrolling
Game-play, ADHD in children ages 6 to 12 years old 63 62 5 months, across 2 Alliance sites
2014 Closed
Phase II, Multiple Dose, POC, Cognition in Stable Schizophrenia 66 41 10 months, across 2 Alliance sites
2013 Closed
Flexible-Dose, Generalized Anxiety Disorder 43 22 6 months, across 2 Alliance sites
2013 Closed
Phase III, Mild to Moderate Alzheimer’s Disease (includes IGIV, and infusion)
15 10 14 months 2013 TOP ENROLLER
OL, Daily Subcutaneous Injections, Relapsing-Remitting Multiple Sclerosis
7 6 2 weeks 2013 Closed
Phase III, OL, Moderate to Severe Chronic Nonmalignant and Non-neuropathic Pain
22 20 3 months 2012 Closed
Phase IV, Smoking Cessation 58 45 2 months 2011 Closed
Phase III, Bipolar I Disorder 23 16 9 months 2011 TOP ENROLLER
Phase III, Once Daily Controlled Release, Fibromyalgia (includes Actigraphy, PK, Multiple Psychiatric, Sleep & Pain Assessments, and Diary)
49 33 7 months 2011 TOP ENROLLER
Phase III, OL, Single-Arm, ER Capsules, Moderate to Severe Chronic Non-cancer Pain
28 24 3 months 2011 TOP ENROLLER
Phase IIa, Two Dose Regimens, Parkinson's Disease 11 10 1 month 2010 RESCUE SITE
www.alliancesites.com
Curricula Vitae
CNS, LLC. David P. Walling, Ph.D. Armen K. Goenjian, M.D. Lara Shirikjian, D.O. Omid Omidvar, M.D. Nirav S. Patel, M.D. Steven Reynolds, D.O. Mark Leibowitz, M.D.
Pacific Research Partners, LLC.
Ira D. Glick, M.D. Anand Mehta, M.D. Corinna Gamez, M.D.
FutureSearch Trials, L.P.
John Douglas Hudson, M.D. Edward Ortiz, M.D. Michael Downing, M.D.
Oregon Center for Clinical Investigations, Inc. Beal Essink, M.D. Alexander Horwitz, M.D. Drissana Tran, M.D.
Click on name below to download CV
Hassman Research Institute, LLC. Howard Hassman, D.O. Michael Hassman, D.O. Roberta Ball, D.O. Elissa Hassman, D.O. Shawn Hossain, D.O. Joseph Savon, M.D.
Synapse Clinical Research, LLC.
Robert Millet, M.D. Hansen Su, M.D. Gary Clary, M.D.
Albuquerque Neuroscience, Inc.
Glenn Michael Dempsey, M.D. Paula Lane, M.D.
Clinical Trials of the Rockies
Jennifer Lytle, M.D. David Weiss, M.D.
www.alliancesites.com
Contact
For further information on Alliance
services contact:
Bobbie Theodore, M.S. (916) 939-6696
[email protected] www.alliancesites.com