Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique

Clinical Trial Centers Alliance

offering specialized expertise to fit the unique needs of each client

Bobbie TheodoreAlliance Director

[email protected]

www.clinicaltrialcenters.com

Executive Summary

Our Alliance of experienced research sites and services can address portfolio clinical research needs in one bundled package. 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-marketingIntegrated services including protocol development, study conduct, data analysis, monitoring – any or all to meet clinical program needs OR site-only services

Independent (Non-SMO) entities in California, Texas and Florida comprise the AllianceCombined 1,000+ clinical trials conducted, phases I-IVCentral IRBLarge patient databases, affiliated medical practices and proven recruitment methods


Alliance Facilities - CALIFORNIA

CNS, LLCLong Beach, CA – Dedicated 80 Bed specialty Phase I Unit / Inpatient / Outpatient

Principal Investigators: David Walling, PhD, CEO, Mark Leibowitz, MD, Medical Director, Armen Goenjian, MD, Omid Omidvar, MD, Nirav Patel, MD, Steven Reynolds, DO

60+ Bed Clinical Pharmacology Unit – stable psychiatric, CNS, targeted healthy normal volunteers, medical and ethno-bridging special patient population trials

20 Bed Psychiatric Health Facility – licensed psychiatric health care unit, private and semi-private rooms - inpatient acute psychiatric population trials

Outpatient Offices – neurology, pain, and general medical population trials

Garden Grove, CA – Outpatient psychiatry offices – Principal Investigator: David Walling, PhD

Torrance, CA – Outpatient psychiatry - Principal Investigator: Armen Goenjian, MD


Alliance Facilities - CALIFORNIA

Pacific Research Partners, LLC

San Francisco area, CA – Principal Investigator: Ira Glick, MDInpatient - psychiatry (10 beds with flexible capacity) patient population trialsOutpatient Offices – psychiatry, cognition, MCI, pain population trials


Alliance Facilities - TEXAS

FutureSearch Trials, LP

Austin, TX – Principal Investigators: Donald Garcia, Jr., MD, President, and John Hudson, MDInpatient and Outpatient - psychiatry (30 beds) including phase I special population trialsInpatient - 6 bed sleep lab for PSG and sleep trialsOutpatient Offices – sleep, neurology, Alzheimer’s and pain population trials

Dallas, TX – Principal Investigator: Michael Downing, MDInpatient - psychiatry (10 beds with flex capacity) population trialsOutpatient Offices – psychiatry, Alzheimer's disease, cognitive dysfunction, pain, and insomnia population trials

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Alliance Facilities - FLORIDA

Florida Clinical Research Center, LLC

Bradenton, FL – Principal Investigators: Andrew Cutler, MD, CEO, and Jose Zaglul, MDInpatient - psychiatry, pediatric - adult (10 beds with flexible capacity) including phase I population trialsOutpatient Offices – psychiatry, cognitive dysfunction, insomnia, and pain population trials

Maitland, FL – Principal Investigators: Martin Kane, MD, Richard Knapp, DO, and Joanne Northcutt, PhD Inpatient - psychiatry, pediatric – adult (30 beds with flex capacity) population trialsOutpatient Offices – psychiatry, pediatric – adults, cognitive dysfunction, insomnia, and pain population trials


Staff Highlights

Each Research Site Has Fulltime Dedicated and Highly Experienced Staff

Investigators Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Family Practice, and Licensed Clinical PsychologistsProtocol consultants to sponsors and CROs in psychiatry, neurology, sleep indications and phase I study designsFulltime certified psychometric clinical raters – M.D., Ph.D. and M.A.-level with up to 20+ years rating experience

Multiple fulltime study coordinators including CCRCs, RNs, and LVNsDedicated recruitment and outreach specialists with established referral networks in their communitiesRegulatory, QA, training and IT personnel


Specialized Capabilities and Experience

Dedicated 80 bed Clinical Pharmacology Unit (CPU) in Long Beach, CAHealthy subjects, and special patient populationsCardiac, telemetry and holter monitoringQTc and Thorough QTcEEG and qEEG Evoked potentialsSerial PK and ECG1.5 and 3T MRI, fMRI bold and 64-Slice PET/CT system imagingLumbar puncture and CSF collection PSG (polysomnography) Infusion, oral, device, and transdermal patch delivery systems


Phase I-IV Trial Experience

PsychiatryAddictions – smoking cessation, alcohol dependence, binge eatingADHD – adult and child, including classroom ADHDAnxiety – GAD, PTSDBipolar – bipolar depression, mania, mixedCognition – in schizophrenia, mild cognitive impairmentDepression – MDD, refractory/treatment resistant, depression with sexual dysfunctionSchizophrenia and schizoaffective disorders – acute, cognitive dysfunction, negative symptoms, stablePediatric psychiatry

NeurologyAlzheimer’s – MCI, prodromal, mild, moderate, and severeParkinson’s – early stage to advancedPost-strokeMultiple Sclerosis – relapsing remittingSleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea

PainChronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgia

General MedicalCOPD, asthma, hypercholesterolemia, hypertension, obesity, OIC, type 2 diabetes, women’s health


Recruitment and Retention

RecruitmentFull time dedicated recruitment and outreach specialists on staffLarge databases accumulated over 13+ years of research across all indicationsAffiliated PI physician private and group practice databasesEstablished relationships with network of physicians for additional patient referralsOutreach to and established relationships with residential facilities, board and cares, senior communitiesParticipation in community events and support groups – provide free seminars, lunch and learnsHistory of successful print, web, radio, and television advertising – recruitment departments have established relationships with media buyers for discounted advertising rates and preferred placementAbility to pre-qualify patients via IRB-approved pre-screen consent form

RetentionInpatient facilities have private rooms, double occupancy for caregivers or loved ones as neededSite-provided patient transportation as neededFulltime dedicated staff for regular communication with patient and family, reminder and follow-up phone callsMany of the study patients are treated in the Investigator’s practices allowing for ease in transition, follow up, and retention


Affiliated Practices

Affiliated Medical PracticesCNS, CA is aligned with Drs. Goenjian, Omidvar, Patel and Reynolds 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 Counties.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.


Alliance Advantages and Expertise

Menu of site and study management services based on sponsor needResponsiveness and ease of single point of contact with sponsor relations team Dedicated regulatory/budget/contract staff for quick turnaround times including use of Central IRBBest clinical and operational practices shared across sitesThought leaders in CNS and Phase I indications with multiple publications, and advisory board membershipsClinical, budget, and protocol feedback during development process, if neededEstablished vendor relationships for seamless execution


Psychiatry Sample Metrics

Study Title# of Patients

Screened# of Patients Randomized

Length of Enrollment Year Status

A 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 month(across 2 sites)

2013 Closed

A 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

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

43 22 6 months (across 2 sites)

2013 Active

A 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

A 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

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



Phase I Sample Metrics




A 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

Contracted for 5 cohorts

of 12 (60)Screened 90

enrolled 60 (5 cohorts of 12)

5 months 20132014

Active – 1 site

A Phase I, 2-part, Open Label, Inpatient Study to Assess the Safety and Tolerability of Multiple Ascending Doses of XXX in Subjects with Schizophrenia (Extensive PKs & multiple ECGs)


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

A Phase I, Inpatient Multicenter, Open-Label Study to Determine the Effects of XXX on Sleep in Healthy Subjects


SITE

A 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 sites)

2011 TOP ENROLLING

SITE

A 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 20122013

TOP ENROLLING

SITE


Neurology Sample Metrics




A 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

An 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 Active

Pilot Epilepsy Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data


A 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)


A 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


Pain Sample Metrics




A 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 Nonneuropathic Pain


A 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

A 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 Noncancer Pain


SITE

A Phase III, Safety and Tolerability Study Comparing XXX Given as an Oral Solution to a Single-blinded Combination of Oral Tablets plus Oral Solution in Subjects with Fibromyalgia


A Six Month 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 sites)

2010 Closed


Curriculum Vitae

Click on PI names to view CVs: 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, LLCMark Leibowitz, M.D. – PI – CNS, LLC Ira D. Glick, M.D. PI – Pacific Research Partners, LLCDonald J. Garcia, M.D. President and PI – FutureSearch Clinical Trials, LPJohn Douglas Hudson, M.D. PI– FutureSearch Trials of Neurology, LPMichael Downing, M.D. PI– FutureSearch Trials of Dallas, LPAndrew J. Cutler, M.D. CEO and PI – Florida Clinical Research Center, LLCJose T. Zaglul, M.D. PI – Florida Clinical Research Center, LLCRichard D. Knapp, D.O. PI – Florida Clinical Research Center, LLCJoanne Northcutt, Ph.D. PI – Florida Clinical Research Center, LLCMartin Kane, M.D. PI – Florida Clinical Research Center, LLC

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Conclusion

For further information on Alliance services contact:

Bobbie Theodore(916) 939-6696

[email protected] www.clinicaltrialcenters.com

mailto:[email protected]

http://www.clinicaltrialcenters.com/

Documents

Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique