clinical trial centers alliance · 2016. 4. 27. · health clinics. oregon center for clinical...

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

Executive Summary

Locations

Facilities

California

Texas

Florida

New Mexico

Colorado

New Jersey

North Carolina

Oregon

Staff Highlights

Capabilities

Therapeutic Areas

Recruitment and Retention

Affiliated Practices

Advantages

Testimonials

Sample Metrics

Cognitive Research Corporation

Curricula Vitae

Contact

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Table of Contents

www.alliancesites.com

Executive Summary

Our Alliance of experienced research sites and services can address all stages of clinical research activities. We propose flexible options to serve your clinical development needs as follows:

A menu of services under one liaison and contract

Expertise across a range of therapeutic areas, phase I through post-marketing

Integrated services including clinical site conduct, with or without bundled CRO services such as protocol development, trial management, data management, statistical analysis, monitoring, rater training – any or all to meet your clinical program needs

Independent (Non-SMO) entities in California, Texas, Florida, New Mexico, Colorado, New Jersey, North Carolina, and Oregon comprise the Alliance Combined 2,000+ clinical trials conducted, phases I-IV Central IRB Large patient databases, affiliated medical practices and proven recruitment methods


Alliance Facilities – CALIFORNIA

Clinical Pharmacology Unit: 2600 Redondo Avenue, Suite 500, Long Beach, CA 90806 Principal Investigators: David Walling, Ph.D., (CEO) Psychologist Mark Leibowitz, M.D, (Early Phase Medical Director) Board Certified Internist Armen Goenjian, M.D, (Medical Director) Board Certified Psychiatrist Omid Omidvar, M.D., Board Certified Neurologist Nirav Patel, M.D., Board Certified Neurologist Steven Reynolds, D.O., Board Certified Family Practitioner

50+ bed CPU – healthy subjects, and stable psychiatry, neurology, pain, medical and ethno-bridging trials 20+ bed licensed psychiatric hospital (JCAHO accredited) – acute psychiatry trials Outpatient offices – Alzheimer’s, neurology, pain, and medical trials

Collaborative Neuroscience Network, LLC. (CNS)

https://app.box.com/shared/static/k6n4lnkczn3htam3bv0u.ppsx



CNS Continued: 12772 Valley View Street, Suite 3, Garden Grove, CA 92845 Principal Investigator: David Walling, Ph.D. 19401 S. Vermont Avenue, Suite F-100, Torrance, CA 90502 Principal Investigators: Armen Goenjian, M.D., Board Certified Psychiatrist Lara Shirikjian, D.O., Board Certified Psychiatrist

Outpatient – psychiatry trials



Pacific Research Partners, LLC. 901 Clay Street, Oakland, CA 94607 (San Francisco Bay area) Principal Investigators: Ira Glick, M.D., Board Certified Psychiatrist Anand Mehta, M.D., Double Boarded in Internal Medicine and Endocrinology Simret Nanda, M.D., Board Certified Psychiatrist Corinna Gamez, M.D., Board Certified Psychiatrist Inpatient and Outpatient –adult psychiatry trials Outpatient – Alzheimer’s, pain, and general medical trials


Alliance Facilities - TEXAS

FutureSearch Trials of Neurology, L.P.

5508 Parkcrest Dr., Ste. 300, Austin, TX 78731 Principal Investigators: John D. Hudson, M.D., Double Boarded in Neurology and Sleep Medicine Edward H. Ortiz, M.D., Double Boarded in Pulmonary and Sleep Medicine

Outpatient – Sleep, pain, neurology, respiratory, and general medical disorders Inpatient – 6 bed sleep lab for PSG and sleep trials

https://www.box.com/shared/static/gm85rtss97g0pyvodl7k.ppsx


Alliance Facilities - TEXAS

Inpatient and Outpatient – adult psychiatry trials Outpatient – Alzheimer's, sleep and pain trials

FutureSearch Trials of Dallas, L.P.

5445 La Sierra Drive, Suite 101, Dallas, TX 75231 Principal Investigator: Michael Downing, M.D., Board Certified Psychiatrist


Alliance Facilities – FLORIDA

Meriden Research (formerly FCRC – Bradenton)

8043 Cooper Creek Blvd., Suite 107, Bradenton, Florida 34201 Principal Investigators: Andrew J. Cutler, M.D., (CEO) Double Board Certified in Psychiatry and Internal Medicine Jose T. Zaglul, M.D., Board Certified Psychiatrist and Child Psychiatrist Conrado O. Beckles, Ph.D.

Inpatient and Outpatient –psychiatry, Alzheimer’s, sleep, pain and general medical trials


Alliance Facilities – FLORIDA

Florida Clinical Research Center, LLC.

2300 Maitland Center Parkway, Suite 230, Maitland, FL 32751 Principal Investigators: Martin S. Kane, M.D., Board Certified Psychiatry and Neurology Richard D. Knapp, D.O., Board Certified Psychiatry and Addictions Andrea Marraffino, Ph.D.

Inpatient and Outpatient – psychiatry trials Outpatient – child to adult psychiatry, Alzheimer’s, sleep and pain trials


Alliance Facilities – NEW MEXICO

Albuquerque Neuroscience, Inc.

101 Hospital Loop NE, Suite 209, Albuquerque, NM 87109 Principal Investigators: Glenn Michael Dempsey, M.D., (President) Board Certified Psychiatrist Paula J. Lane, M.D., Family Practice

Outpatient – child to adult psychiatry, Alzheimer's, sleep, pain and general medical trials


Alliance Facilities – COLORADO

Clinical Trials of the Rockies

3955 E. Exposition Avenue, Suite #104, Denver, CO 80209 Principal Investigators: Jennifer Lytle, M.D., Board Certified Psychiatrist David Weiss, M.D., Board Certified Psychiatrist

Outpatient – Psychiatry, addiction, medical devices, sleep, and pain trials


Alliance Facilities – NEW JERSEY

Hassman Research Institute, LLC.

175 Cross Keys Road, Berlin, NJ 08009 Principal Investigators: Howard Hassman, D.O., Board Certified in Family Practice Michael Hassman, D.O., Board Certified in Family Practice Roberta Ball, D.O., Board Certified Psychiatrist

Inpatient and Outpatient – Psychiatry, neurology, cardiology, dermatology, endocrinology, ENT, gastroenterology, internal medicine, OB-GYN, ophthalmology, pain, renal/ hepatic impaired, and human abuse liability trials


Alliance Facilities – NORTH CAROLINA

Synapse Clinical Research, LLC.

4102 Ben Franklin Blvd., Durham, NC 27704 Principal Investigator: Robert A. Millet, M.D., CEO & CSO 209 Millstone Drive, Suite B, Hillsborough, NC 27278 Principal Investigator: Hansen Su, M.D. 289 Olmsted Blvd., Suite 1, Pinehurst, NC 28374 Principal Investigator: Greg Clary, M.D.

Outpatient – psychiatry, Alzheimer’s, and addiction trials


Alliance Facilities – OREGON

Oregon Center for Clinical Investigations, Inc.

905 SE 14th Avenue, Portland, OR 97214 Principal Investigator: Beal G. Essink, M.D., Board Certified in Psychiatry and Sleep Medicine

702 Church Street NE, Salem, OR 97301 Principal Investigators: Alexander E. Horwitz, M.D., Board Certified in Psychiatry and Forensic Psychiatry Drissana Tran, M.D., Board Eligible in Internal Medicine Outpatient – Psychiatry, Alzheimer’s, eating disorders, general medical, and sleep trials


Alliance Staff Highlights

Full-Time Dedicated And Highly Experienced Staff

Investigators are Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Family Practice, Endocrinology, Pulmonology, and Licensed Clinical Psychologists

Protocol consultants to sponsors and CROs, and thought leaders in psychiatry, neurology, sleep 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


Alliance Capabilities

Specialized Capabilities and Experience

Dedicated Clinical Pharmacology Unit (CPU) Healthy subjects Special patient populations including Asian bridging, renal and hepatic impaired, and abuse liability Telemetry and holter cardiac monitoring QTc and TQTc EEG and qEEG evoked potentials Serial PK and ECG Imaging, 1.5 and 3T MRI, and fMRI Lumbar puncture and CSF collection PSG (polysomnography) Infusion, injection, oral, device, implant and transdermal patch delivery systems Software / Neurogaming Product Validation


Alliance Therapeutic Areas

Psychiatry Phase I-IV Addictions – smoking cessation, alcohol dependence, binge eating, opioid, drug, human abuse liability

ADHD – adult and child, including analog classroom

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

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


Alliance Therapeutic Areas cont’d

Pain Phase I-IV Chronic pain

Fibromyalgia

Migraine

Neuropathic Pain

Osteoarthritis

Post herpetic neuralgia

General Medical Phase I-IV Asthma, COPD

Diabetes

Hypercholesterolemia

Hypertension

Obesity

Constipation and opioid induced constipation

Dermatology

Neutraceuticals

Vaccines

Women’s health


Alliance Recruitment and Retention

Recruitment Full-time dedicated recruitment and outreach specialists on staff Extensive databases across all indications Affiliated PI private and group practices (psychiatry, neurology, family practice, sleep, endocrinology) 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 Relationships with media buyers for discounted advertising rates and preferred placement Ability to pre-qualify patients via IRB-approved pre-screen consent form

Retention Inpatient facilities have private and semi-private rooms, double occupancy for caregivers or loved ones as needed Site-provided patient transportation as needed 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


Alliance Affiliated Practices Affiliated Medical Practices

Collaborative Neuroscience Network, LLC., CA is aligned with Drs. Goenjian, Omidvar, Patel and Reynold’s large psychiatry, neurology and family group practices respectively in the LA and Orange County regions.

Pacific Research Partners, LLC., CA has exclusive relationship with the largest mental health clinics in the San Francisco Bay Area regions, as well as Dr. Mehta’s Bay Area Medical multi-specialty group practice.

FutureSearch Trials of Neurology, L.P., Austin, TX is aligned with Dr. Hudson’s large sleep medicine practice with 6 bed sleep lab on premises of research facility.

FutureSearch Trials of Dallas, L.P., Dallas, TX has Dr. Downing‘s psychiatry practice onsite.

Florida Clinical Research Center, LLC. and Meridien Research (formerly FCRC – Bradenton), FL has exclusive relationships with local mental health clinics and hospitals.

Albuquerque Neuroscience, Inc., NM has relationships with local elderly facilities and community advocacy groups, group psychiatric and medical practices and a large multi-specialty regional organization.

Clinical Trials of the Rockies, CO has Dr. Lytle’s private psychiatry practice onsite.

Hassman Research Institute, LLC., NJ is co-located with 17 multi-specialty practices within medical complex.

Synapse Clinical Research, LLC., NC is exclusively affiliated with Carolina Behavioral Care’s regional mental health clinics.

Oregon Center for Clinical Investigations, Inc., OR is affiliated with Dr. Tran who has been practicing for over 15 years and has been a staff physician at Salem Hospital since 2001 with strong ties to community practitioners and health care providers.


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 consulting

Excellent separation data


Alliance Testimonials Schizophrenia Study Sponsor

Annie [Clinical Trial Centers Alliance] represents several sites and PIs with extensive schizophrenia experience and an excellent track record of distinguishing placebo from active comparators.

Phase I Healthy Japanese Bridging Study Sponsor [Dr. Mark Leibowitz CNS] Congratulations on getting this study initiated so quickly! I heard that all eight subjects were successfully dosed today. Thank you for your hard work to achieve this milestone under such stringent timelines. We appreciate it greatly.

Phase I Schizophrenia Study CRO I wanted to extend an extra special thank you to your [Dr. David Walling][CNS] team. Without your help today we could not have achieved the soft lock milestone. The entire team came together to meet our deliverable. Your staff stayed late on Wednesday (before coordinator’s jury duty), organized the team today and helped with last minute queries. Again, thanks for your continued hard work on the project and it’s been a pleasure to work with the team. Thanks.

Depression Study Sponsor Dr. [Andrew] Cutler and Patricia, [Florida Clinical Research Center, LLC.] YOU are NUMBER 1. My sincere appreciation and my congratulations to you for screening the first subject in the XXX depression study. The ice is broken and the ship has now sailed. Thank You

Schizophrenia Study CRO Dr. [Armen] Goenjian, [CNS], Congratulations!! Your site is the first that has reached the recruitment cap of 18 patients randomized in the XXX Suboptimal study. On behalf of the team, I would like to thank you and your site staff for the hard work and for being the first site to reach this goal!!

http://www.clinicaltrialcenters.com/alliance/principal-investigators/







Alliance Testimonials cont'd ADHD Study Sponsor

Dr. [Andrew] Cutler, Patti, and Florida Clinical Research Center, LLC. staff have been wonderful throughout their work on our studies. The team exceeded their enrollment goal and closed the study with a remarkably low screen failure and early discontinuation rate. In addition, and the quality of their work on both studies has been exceptional – their source and CRF data have been clean resulting in cost and time savings for our monitoring and data management activities. Dr. Cutler has also been incredibly helpful by collaborating with our team on patient recruitment strategies, the appropriate use of our study diagnostic tool, and sharing his thoughts about future development work with the compound.

Alzheimer’s Study Sponsor Good afternoon Dr. [Omid] Omidvar, [CNS], I am writing to invite you to participate in a Phase IIb Alzheimer’s trial. You and your team were one of the top enrolling sites for the XXX Elderly MRD [memory-related disease] trial and we think that you and your team could be perfect for the trial.

Multiple Sclerosis Study Sponsor Hi all, XXX (Senior Director of Clinical Operations with XXX) came by to meet with Dr. [Nirav] Patel, Anne Cabral, and the [CNS] team to acknowledge the outstanding job we all did on the XXX (MS) spasticity study! According to some of his internal metrics, we were performing at 300+% compared to other sites. That is amazing!

Migraine Study Sponsor Dr. [John] Hudson and FutureSearch Trials of Neurology, L.P.] the XXX study team appreciates your efforts to reduce screen failures for this study. Currently, you have the lowest SF rate out of 40 US sites and the most randomized patients. XXX appreciates your efforts and expertise in this clinical trial.

Insomnia Sleep Sponsor Dear Dr. [John] Hudson, [FutureSearch Trials of Neurology, L.P.], I hope you are doing well. I was reviewing the XXX-sponsored trial enrollment numbers in my region, and was impressed with your enrollment numbers in the PSG study. I just wanted to say thank you so much for all of the hard work by you and your staff!












Alliance Sample Metrics

Study Title # of Patients

Screened # of Patients Randomized

Length of Enrollment Year Status

Phase I, Open-Label, Randomized, Multiple Dose, Safety and Pharmacokinetic Trial with Injectable XXX Compared to XXX in Patients with Chronic, Stable Schizophrenia or Schizoaffective Disorder

Contracted for 4 cohorts

of 10 (40)

Screened 116

60 patients

Plus back up subjects

3 months, single site

2015 Closed

Phase I, Rising Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXX in Healthy Adult Japanese Subjects - Part I and II


of 8 (16)

Enrolled 16 < 2 months over the holidays, single site

Nov-Dec

2014

Closed

Phase I, Prospective, Randomized, Double-blind, Placebo-controlled, Sequential-cohort, Escalating, Single-dose Study designed to determine the maximum tolerated oral dose of XXX in Healthy, Male volunteers – 3 days/2 overnights


of 12 (60)

Screened 110

Enrolled 60 plus back up

subjects


2013

2014

Closed

Phase I, Randomized Single-Blind, Placebo-Controlled, Ascending Single Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of XXX in Male and Female Subjects with Schizophrenia AND Ascending Multiple Oral Dose Study

Contracted for 7 cohorts of 15 (105)

Screened 128

Enrolled 93 plus back up

subjects


2014 RESCUE SITE

Phase I, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of XXX in Subjects With Mild to Moderate Alzheimer’s Disease

Study design 5 cohorts;

1 pt/cohort from ea site

20 patients enrolled (2

cohorts of 10 each)

12 months, multi-site

2012

2013

TOP ENROLLING

SITE


Sample Metrics cont’d




Phase II, 12 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose, Proof-of-Concept Study to Evaluate the Effects of XXX on Cognition in Stable Schizophrenia Patients

66 41 10 months,

across 2 Alliance sites

2013 Closed

Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX IM Depot Administered in the Deltoid Muscle in Adult Subjects with Schizophrenia

40 28 1 month,

single site

2013 Closed

Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder

43 22 6 months, across 2 Alliance

sites

2013 Closed

Phase IV, Multi-national, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX compared to Placebo for Smoking Cessation Through Reduction

58 45 2 months 2011 Closed

Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with Bipolar I Disorder

23 16 9 months 2011 TOP ENROLLING SITE

Phase I, Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of XXX in Major Depressive Disorder Subjects (Extensive PKs & multiple ECGs)

38 22 6 weeks,


2011 TOP ENROLLING SITE






Open Label Study to assess the feasibility of XXX, game-play, to engage subjects with Attention Deficit Hyperactivity Disorder (ADHD) and to evaluate interference cost in children ages 6 to 12 years old with ADHD compared to age-matched controls

63 42 5 months,


2013 Closed

Phase III, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of XXX for the Treatment of Mild to Moderate Alzheimer’s Disease (includes IGIV, and infusion)

15 10 14 months 2013 TOP ENROLLING

SITE

Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of XXX 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects with Relapsing-Remitting Multiple Sclerosis

7 6 2 weeks 2013 Closed

Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed-dose, Study to Assess Efficacy, Safety and Tolerability of XXX in Adults with Inattentive-Predominant Attention Deficit/ Hyperactivity Disorder (ADHD)


Phase IIa Randomized, Double-Blind, Cross over Study Comparing the Tolerability of Two Dose Regimens of XXX in Adult Patients with Parkinson's Disease who are receiving XXX

11 10 1 month 2010 RESCUE SITE






Phase III, Open-Label, Multicenter Study to Assess the Long -Term Safety of XXX Once-Daily in Subjects with Moderate to Severe Chronic Nonmalignant and Non-neuropathic Pain


Phase III, Double-blind, Randomized, Placebo-controlled, Safety and Efficacy Study of Once Daily Controlled Release XXX in the Treatment of Patients with Fibromyalgia (13-week single and double blind phases, outpatient study including Actigraphy, PK, Multiple Psychiatric, Sleep & Pain Assessments, and Diary)


SITES

Phase III, Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of XXX and XXX Extended-Release Capsules in Subjects With Moderate to Severe Chronic Non-cancer Pain


SITES

Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of XXX for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine

42 41 3 months,


2010 Closed


Alliance 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. Simret Nanda, M.D. Corinna Gamez, M.D.

FutureSearch Trials, L.P.

John Douglas Hudson, M.D. Edward Ortiz, M.D. Michael Downing, 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.

Synapse Clinical Research, LLC.

Robert Millet, M.D. Hansen Su, M.D. Gary Clary, M.D.

Oregon Center for Clinical Investigations, Inc.

Beal Essink, M.D. Alexander Horwitz, M.D. Drissana Tran, M.D.

Florida Clinical Research Center, LLC. Richard D. Knapp, D.O. Martin Kane, M.D. Andrea Marraffino, Ph.D.

Meridien Research

Andrew J. Cutler, M.D. Jose T. Zaglul, M.D. Conrado O. Beckles, Ph.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.

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Contact

For further information on Alliance

services contact:

Bobbie Theodore, M.S. (916) 939-6696

[email protected] www.alliancesites.com

mailto:[email protected]

http://www.clinicaltrialcenters.com/

clinical trial centers alliance · 2016. 4. 27. · health clinics. oregon center for clinical...

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