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

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Presentation on theme: "Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique."— Presentation transcript:

1 Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique needs of each client Bobbie Theodore Alliance Director

2 Executive Summary Our Alliance of experienced research sites and services can address portfolio clinical research needs. 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

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

4 Alliance Facilities - C ALIFORNIA CNS, LLC Long Beach, CA – 25,000 sq ft Clinical Pharmacology Unit and Licensed Psychiatric HospitalClinical Pharmacology Unit PI’s: David Walling, PhD, CEO, Mark Leibowitz, MD, Early Phase Medical Director, Armen Goenjian, MD, Medical Director, Omid Omidvar, MD, Nirav Patel, MD, Steven Reynolds, DO Dedicated 60+ Bed Phase I Unit – stable psychiatric, CNS, targeted healthy normal volunteers, medical and ethno-bridging special patient population trials Dedicated 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 – PI: David Walling, PhD Torrance, CA – Outpatient psychiatry - PI: Armen Goenjian, MD

5 Alliance Facilities - C ALIFORNIA Pacific Research Partners, LLC San Francisco area, CA – Principal Investigator: Ira Glick, MD Inpatient - psychiatry patient population trials Outpatient – psychiatry, cognition, MCI, pain population trials

6 Alliance Facilities - T EXAS FutureSearch Trials, LP Austin, TX – PI’s: Donald Garcia, Jr., MD, President, and John Hudson, MD Inpatient and Outpatient - psychiatry including phase I special population trials, pediatric - adult Inpatient - 6 bed sleep lab for PSG and sleep trials6 bed sleep lab Outpatient – sleep, neurology, Alzheimer’s and pain population trials Dallas, TX – PI: Michael Downing, MD Inpatient - psychiatry (10 beds with flex capacity) population trials, pediatric - adult Outpatient – psychiatry, Alzheimer's disease, cognitive dysfunction, pain, and insomnia population trials

7 Alliance Facilities - F LORIDA Florida Clinical Research Center, LLC Bradenton, FL – PI’s: Andrew Cutler, MD, CEO, and Jose Zaglul, MD Inpatient - psychiatry, including targeted special phase I population trials, pediatric - adult Outpatient – psychiatry, cognitive dysfunction, insomnia, and pain population trials Maitland, FL – PI’s: Martin Kane, MD, Richard Knapp, DO, and Joanne Northcutt, PhD Inpatient – psychiatry population trials, pediatric - adult Outpatient – psychiatry, cognitive dysfunction, insomnia, and pain population trials, pediatric - adult

8 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 Psychologists Protocol consultants to sponsors and CROs in psychiatry, neurology, sleep indications and phase I study designs Fulltime 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 LVNs Dedicated recruitment and outreach specialists with established referral networks in their communities Regulatory, QA, training and IT personnel

9 Specialized Capabilities and Experience Dedicated Clinical Pharmacology Unit (CPU) in Long Beach, CA Healthy subjects, and special patient populations Cardiac, telemetry and holter monitoring QTc and TQTc EEG and qEEG Evoked potentials Serial PK and ECG 1.5 and 3T MRI, fMRI bold and 64-Slice PET/CT system imaging Lumbar puncture and CSF collection PSG (polysomnography) Infusion, injection, oral, device, and transdermal patch delivery systems

10 Phase I-IV Trial Experience Psychiatry Addictions – smoking cessation, alcohol dependence, binge eating ADHD – adult and child, including classroom ADHD Anxiety – GAD, PTSD Bipolar – bipolar depression, mania, mixed Cognition – in schizophrenia, mild cognitive impairment Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction Schizophrenia and schizoaffective disorders – acute, cognitive dysfunction, negative symptoms, stable Pediatric psychiatry Neurology Alzheimer’s – MCI, prodromal, mild, moderate, and severe Parkinson’s – early stage to advanced Post-stroke Multiple Sclerosis – relapsing remitting Sleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea Pain Chronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgia General Medical COPD, asthma, hypercholesterolemia, hypertension, obesity, OIC, type 2 diabetes, women’s health

11 Recruitment and Retention Recruitment Full time dedicated recruitment and outreach specialists on staff Large databases accumulated over 13+ years of research across all indications Affiliated PI physician private and group practice databases Established relationships with network of physicians for additional patient referrals Outreach to and established relationships with residential facilities, board and cares, senior communities Participation in community events and support groups – provide free seminars, lunch and learns History of successful print, web, radio, and television advertising – recruitment departments have established 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 Fulltime dedicated staff for regular communication with patient and family, reminder and follow- up phone calls Many of the study patients are treated in the Investigator’s practices allowing for ease in transition, follow up, and retention

12 Affiliated Practices Affiliated Medical Practices CNS, 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.

13 Alliance Advantages and Expertise Menu of site and study management services based on sponsor need Responsiveness and ease of single point of contact with sponsor relations team Dedicated regulatory/budget/contract staff for quick turnaround times including use of Central IRB Best clinical and operational practices shared across sites Thought leaders in CNS and Phase I indications with multiple publications, and advisory board memberships Clinical, budget, and protocol feedback during development process, if needed Established vendor relationships for seamless execution

14 Cognitive Research Corporation Collaboration Based on sponsor’s requests for full service proposals, now offering a streamlined solution that evolved from our expanded early phase capabilities Cognitive Research Corporation (CRC) is a boutique, full-service CRO with decades of clinical trial experience specializing in conducting drug, device, and nutraceutical trials from early development to final analysis Collaborative (non-exclusive) relationship with Alliance sites allows flexibility for CRO proposals, site-only services or bundled options per sponsor preference Menu of services Trial Design (Phase I-IV)Phase I-IV Clinical Trial Management Established network Investigators Data Management Biostatistics Medical Writing Regulatory Affairs Quality Assurance Early Drug Development (Phase I, healthy subjects, and specialty populations)Phase I, healthy subjects, and specialty populations Expertise in neuro-cognitive testing including state of art, world class driving simulation

15 Psychiatry Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus 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 month ( across 2 sites ) 2013Closed 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 month2013Closed A Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder months (across 2 sites) 2013Closed 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 months2011Closed A Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with Bipolar I Disorder months2011TOP 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 months2010Closed

16 Phase I Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus 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 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) months2012Closed 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 5420 (SFs due to pts not having a migraine in req’d window) 8 months2012 TOP ENROLLING SITE A Phase I, Inpatient Multicenter, Open-Label Study to Determine the Effects of XXX on Sleep in Healthy Subjects months2012 TOP ENROLLING 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) weeks (across 2 sites) 2011TOP 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 TOP ENROLLING SITE

17 Neurology Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus 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) months2013TOP ENROLLING 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 762 weeks2013Closed Pilot Epilepsy Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data 556 months2013Closed 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) months2012Closed 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 month2010RESCUE SITE

18 Pain Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus 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 months2012Closed 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) months2011TOP ENROLLING 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 months2011TOP ENROLLING 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 months2010Closed 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 months (across 2 sites) 2010Closed

19 Curriculum Vitae Click on PI names to view CVs: David P. Walling, Ph.D. 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. Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS, LLC Omid Omidvar, M.D. Omid Omidvar, M.D. PI – CNS, LLC Nirav S. Patel, M.D. Nirav S. Patel, M.D. PI – CNS, LLC Steven Reynolds, D.O.Steven Reynolds, D.O. PI – CNS, LLC Mark Leibowitz, M.D.Mark Leibowitz, M.D. – PI – CNS, LLC Ira D. Glick, M.D. Ira D. Glick, M.D. PI – Pacific Research Partners, LLC Donald J. Garcia, M.D. Donald J. Garcia, M.D. President and PI – FutureSearch Clinical Trials, LP John Douglas Hudson, M.D. John Douglas Hudson, M.D. PI– FutureSearch Trials of Neurology, LP Michael Downing, M.D. Michael Downing, M.D. PI– FutureSearch Trials of Dallas, LP Andrew J. Cutler, M.D. Andrew J. Cutler, M.D. CEO and PI – Florida Clinical Research Center, LLC Jose T. Zaglul, M.DJose T. Zaglul, M.D. PI – Florida Clinical Research Center, LLC Richard D. Knapp, D.O. Richard D. Knapp, D.O. PI – Florida Clinical Research Center, LLC Joanne Northcutt, Ph.D.Joanne Northcutt, Ph.D. PI – Florida Clinical Research Center, LLC Martin Kane, M.D.Martin Kane, M.D. PI – Florida Clinical Research Center, LLC

20 Contact For further information on Alliance services contact: Bobbie Theodore (916)


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