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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 clinicaltrials@btheodore.com www.clinicaltrialscenters.com

2 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- marketing Integrated services including protocol development, study conduct, data analysis, monitoring – any or all to meet clinical program needs OR site- only services

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 www.clinicaltrialcenters.com Alliance Facilities - C ALIFORNIA CNS, LLC Long 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

5 www.clinicaltrialcenters.com Alliance Facilities - C ALIFORNIA Pacific Research Partners, LLC San Francisco area, CA – Principal Investigator: Ira Glick, MD Inpatient - psychiatry (10 beds with flexible capacity) patient population trials Outpatient Offices – psychiatry, cognition, MCI, pain population trials

6 www.clinicaltrialcenters.com Alliance Facilities - T EXAS FutureSearch Trials, LP Austin, TX – Principal Investigators: Donald Garcia, Jr., MD, President, and John Hudson, MD Inpatient and Outpatient - psychiatry (30 beds) including phase I special population trials Inpatient - 6 bed sleep lab for PSG and sleep trials6 bed sleep lab Outpatient Offices – sleep, neurology, Alzheimers and pain population trials Dallas, TX – Principal Investigator: Michael Downing, MD Inpatient - psychiatry (10 beds with flex capacity) population trials Outpatient Offices – psychiatry, Alzheimer's disease, cognitive dysfunction, pain, and insomnia population trials

7 www.clinicaltrialcenters.com Alliance Facilities - F LORIDA Florida Clinical Research Center, LLC Bradenton, FL – Principal Investigators: Andrew Cutler, MD, CEO, and Jose Zaglul, MD Inpatient - psychiatry, pediatric - adult (10 beds with flexible capacity) including phase I population trials Outpatient 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 trials Outpatient Offices – psychiatry, pediatric – adults, cognitive dysfunction, insomnia, and pain population trials

8 www.clinicaltrialcenters.com 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 www.clinicaltrialcenters.com Specialized Capabilities and Experience Dedicated 80 bed Clinical Pharmacology Unit (CPU) in Long Beach, CA Healthy subjects, and special patient populations Cardiac, telemetry and holter monitoring QTc and Thorough QTc 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, oral, device, and transdermal patch delivery systems

10 www.clinicaltrialcenters.com 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 Alzheimers – MCI, prodromal, mild, moderate, and severe Parkinsons – 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, womens health

11 www.clinicaltrialcenters.com 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 Investigators practices allowing for ease in transition, follow up, and retention

12 www.clinicaltrialcenters.com 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. Hudsons sleep medicine/neurology practice and sleep lab on premises of research facility. FutureSearch Trials, Dallas, TX is aligned with Dr. Downings 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. Zagluls large child and adult mental health agency and residential facilities.

13 www.clinicaltrialcenters.com 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 www.clinicaltrialcenters.com 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 664110 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 40281 month2013Closed A Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder 43226 months (across 2 sites) 2013Active 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 58452 months2011Closed A Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with Bipolar I Disorder 23169 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 32243 months2010Closed

15 www.clinicaltrialcenters.com 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 months2013 2014 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) 62408 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 reqd 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 26135 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) 38226 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 Alzheimers Disease Study design 5 cohorts; 1 pt/cohort from ea site 20 patients enrolled (2 cohorts of 10 each) 12 months2012 2013 TOP ENROLLING SITE

16 www.clinicaltrialcenters.com 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 Alzheimers Disease (includes IGIV, and infusion) 151014 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 weeks2013Active 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) 32275 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 11101 month2010RESCUE SITE

17 www.clinicaltrialcenters.com 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 22203 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) 49337 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 28243 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 14122 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 42413 months (across 2 sites) 2010Closed

18 www.clinicaltrialcenters.com 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

19 www.clinicaltrialcenters.com Conclusion For further information on Alliance services contact: Bobbie Theodore (916) 939-6696 clinicaltrials@btheodore.com www.clinicaltrialcenters.com


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