Clinical Trial Centers Alliance · Alliance Facilities - TEXAS Outpatient– child to adult...

Clinical Trial Centers Alliance

offering specialized expertise to fit the unique needs of each client

Bobbie Theodore Alliance Director

[email protected] www.clinicaltrialscenters.com

www.clinicaltrialcenters.com

Executive Summary

Our Alliance of experienced research sites and services can address portfolio 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 – any or all to meet your clinical program needs

Independent (Non-SMO) entities in California, Texas, Florida, and New Mexico comprise the Alliance Combined 1,000+ clinical trials conducted, phases I-IV Central IRB Large patient databases, affiliated medical practices and proven recruitment methods


Alliance Facilities –

CALIFORNIA

Principal Investigators:

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

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


Alliance Facilities – CALIFORNIA

CNS Continued: Outpatient psychiatry offices:

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 Investigator: Armen Goenjian, M.D.


Alliance Facilities – CALIFORNIA

Pacific Research Partners, LLC 1611 Telegraph Avenue, Suite 1550, Oakland, CA 94612 (San Francisco Bay area) Principal Investigators: Ira Glick, M.D., Psychiatrist and Anand Mehta, MD, Double Boarded in Internal Medicine and Endocrinology

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


Alliance Facilities - TEXAS

Outpatient– child to adult psychiatry, Alzheimer’s, MCI, sleep, pain trials Inpatient - 6 bed sleep lab for PSG and sleep trials

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

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

FutureSearch Trials, LP

5508 Parkcrest Dr., Ste. 300, Austin, TX 78731 Principal Investigators: Donald Garcia, M.D., Psychiatrist, Carmen Zegarra, M.,. Psychiatrist, And John D. Hudson, M.D., Double Boarded in Neurology and Sleep Medicine

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


Alliance Facilities – FLORIDA

Florida Clinical Research Center, LLC 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, and Jose T. Zaglul, M.D., Child Psychiatrist

Inpatient and Outpatient –psychiatry, Alzheimer’s, sleep, pain and general medical trials including targeted special phase I patient populations

2300 Maitland Center Pkwy, Ste. 230, Maitland, FL 32751 Principal Investigators: Martin S. Kane, M.D., Board Certified Psychiatry and Neurology, and Richard D. Knapp, D.O. Board Certified in Psychiatry and Addictions

Inpatient and Outpatient – psychiatry and addiction trials including targeted special phase I 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) Psychiatrist, and Paula J. Lane, Family Practice

Outpatient – child to adult psychiatry, Alzheimer's, sleep, pain and general medical 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, 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 50 bed Clinical Pharmacology Unit (CPU) Healthy subjects Special patient populations including Asian bridging 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


Alliance Therapeutic Areas

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

ADHD – adult and child, including analog classroom

Anxiety – GAD, PTSD

Bipolar – bipolar depression, mania, mixed

Cognitive dysfunction

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, Traumatic brain injury, 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 Osteoarthritis

Post herpetic neuralgia

General Medical Phase I-IV Asthma, COPD

Diabetes

Hypercholesterolemia

Hypertension

Obesity

OIC

Respiratory

Vaccines

Women’s health


Alliance Recruitment and Retention

Recruitment Full-time dedicated recruitment and outreach specialists on staff Extensive databases accumulated since 2000 across all indications Affiliated PI private and group practices (psychiatry, neurology, family practice, sleep) Established relationships with physician network 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 print, online, radio, and television advertising 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 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, 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, 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, Austin, TX is aligned with Dr. Hudson’s sleep medicine/neurology practice and sleep lab on premises of research facility.

FutureSearch Trials, Dallas, TX is aligned with Dr. Downing‘s psychiatry practice. Both Austin and Dallas sites have established community referral relationships with several residential facilities and mental health agencies.

Florida Clinical Research Center, FL is aligned with Dr. Zaglul’s large child and adult mental health agency and residential facilities. Drs. Knapp and Marraffino are aligned with The Center for Drug Free Living.

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


Alliance Advantages

Advantages and Expertise

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

Best clinical and operational practices shared across sites

Thought leaders in CNS and Phase I designs

Multiple publications and advisory board memberships

Protocol development feedback and clinical costs provided if needed

Established vendor relationships for seamless execution


Alliance Testimonials 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] 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!!

Schizophrenia Study Sponsor Dr. Ira Glick, [Pacific Research Partners] We are planning on closing the screening of potential subjects for Study XXX at the end of December. While this study has been challenging to enroll, you and your site staff have done a tremendous job, both in terms of enrollment (16 subjects screened, 7 randomized) and data quality.

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








Alliance Testimonials cont'd ADHD Study Sponsor

Dr. [Andrew] Cutler, Patti, and Florida Clinical Research Center 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 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] 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], 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 2015 Active

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

Contracted for 2 cohorts of 8

(16)

Enrolled 16 < 2 months over the holidays

Nov-Dec

2014

Active

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


12 (60)

Screened 110

Enrolled 60 plus back up

subjects

5 months 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


15 (105)

Screened 128

Enrolled 93 plus back up subjects

3 months 2014 RESCUE 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 (across 2 Alliance sites)

2011 TOP ENROLLING

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 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 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 III, Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Relapse Prevention Study with XXX in Out-Patient Adults with Major Depressive Disorder







Open Label Study to assess the feasibility of EVO, 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

(across 2 Alliance sites)

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)


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 I, Inpatient Open-Label, Randomized, Parallel Group, Crossover Study to Compare the Pharmacokinetcs of XXX in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period

54 20 (SFs due to pts not having a migraine in req’d window)

8 months 2012 TOP ENROLLING

SITE

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)


SITE

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


SITE

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

(across 2 Alliance

sites)

2010 Closed


Alliance PI's Curricula Vitae

Click on name below to download CV

David P. Walling, Ph.D. CEO and PI – CNS, LLC

Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS, LLC

Omid Omidvar, M.D. PI – CNS, LLC

Nirav S. Patel, M.D. PI – CNS, LLC

Steven Reynolds, D.O. PI – CNS, LLC

Mark Leibowitz, M.D. – PI – CNS, LLC

Ira D. Glick, M.D. PI – Pacific Research Partners, LLC

Anand Mehta, M.D. PI – Pacific Research Partners, LLC

John Douglas Hudson, M.D. PI– FutureSearch Trials of Neurology, LP

Michael Downing, M.D. PI– FutureSearch Trials of Dallas, LP

Andrew J. Cutler, M.D. CEO and PI – Florida Clinical Research Center, LLC

Jose T. Zaglul, M.D. PI – Florida Clinical Research Center, LLC

Richard D. Knapp, D.O. PI – Florida Clinical Research Center, LLC

Martin Kane, M.D. PI – Florida Clinical Research Center, LLC

Glenn Michael Dempsey, M.D. PI – Albuquerque Neuroscience, Inc

Paula J. Lane, M.D. PI – Albuquerque Neuroscience, Inc

http://www.box.net/shared/4aplmydtul

http://www.box.net/shared/4aplmydtul

http://www.box.net/shared/pg0tpq22n4





http://www.box.net/shared/bhbjb4yg42




http://www.box.net/shared/g1f959qym8



http://www.box.com/shared/gv5n105b2b

https://www.box.com/s/q7chloxcb405wywkwani



http://www.box.net/shared/421lnm4rcx

http://www.box.net/shared/static/421lnm4rcx.pdf

https://app.box.com/s/q97laysuk818lntc6uvr



http://www.box.net/shared/12hx6bkcs4

http://www.box.net/shared/aq4zkuqm0t

http://www.box.net/shared/t0yjfqi9u8

http://www.box.net/shared/yrplt95f1f



http://www.box.net/shared/8boqaxfyxx

http://www.box.net/shared/static/8boqaxfyxx.pdf

https://app.box.com/s/x2jezt5znfvf9v81porv

https://app.box.com/s/083yinhv2n36g02hz926cx4deo40pcyw

https://app.box.com/s/7baleclpig26dw533dtrd8xxu0tl2oqv


Contact

For further information on Alliance

services contact:

Bobbie Theodore (916) 939-6696

[email protected] www.clinicaltrialcenters.com

mailto:[email protected]

http://www.clinicaltrialcenters.com/

Clinical Trial Centers Alliance · Alliance Facilities - TEXAS Outpatient– child to adult...

Documents

Transcript of Clinical Trial Centers Alliance · Alliance Facilities - TEXAS Outpatient– child to adult...