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Clinical Trial Centers Alliance. Presented October 2013 Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com. Independent (Non-SMO) entities in California, Texas and Florida comprise the Alliance Combined 500+ clinical trials conducted, phases I-IV
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Clinical Trial Centers Alliance Presented October 2013 Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com
Independent (Non-SMO) entities in California, Texas and Florida comprise the Alliance • Combined 500+ clinical trials conducted, phases I-IV • Central IRB • Large patient databases, affiliated medical practices and proven recruitment methods
Alliance Facilities - California • 25,000 sq ft dedicated research facility • Clinical Pharmacology Unit – 60+ bed phase I unit for healthy subjects, and CNS, general medical, bioequivalence and ethno-bridging patient populations • Psychiatric Health Facility – separate 20 bed, private rooms, licensed psychiatric health care unit for inpatient psychiatric populations • Inpatient and outpatient neurology and general medical patient populations Garden Grove, and Torrance, CA • Outpatient psychiatry • Collaborative Neuroscience Network, LLC Long Beach, CA • Pacific Research Partners, LLC San Francisco area, CA • Inpatient and outpatient psychiatry (10 beds with flexible capacity)
Alliance Facilities - Texas • FutureSearch Trials, LP Austin, TX • Inpatient and outpatient psychiatry (30 beds) including phase I special populations • Inpatient and outpatient sleep disorders (6 bed sleep lab for PSG studies) • Outpatient general medical, neurology and pain disorders Dallas, TX • Inpatient and outpatient psychiatry (10 beds with flex capacity) • Outpatient Alzheimer's disease, cognitive dysfunction, pain, and insomnia disorders
Alliance Facilities - Florida • Outpatient Alzheimer’s, cognitive dysfunction, MCI, general medicine, and pain disorders • Florida Clinical Research Center, LLC Bradenton, FL • Inpatient and outpatient psychiatry, pediatric - adult (10 beds with flexible capacity) • Outpatient general medicine and pain disorders Maitland, FL • Inpatient and outpatient psychiatry, pediatric – adult (30 beds with flex capacity)
CALIFORNIA TEXAS FLORIDA David Walling, PhD ArmenGoenjian, MD Donald Garcia, MD Andrew Cutler, MD Richard Knapp, DO OmidOmidvar, MD Mark Leibowitz, MD Michael Downing, MD Joanne Northcutt, PhD Jose Zaglul, MD Ira Glick, MD Steven Reynolds, DO Nirav Patel, MD John D. Hudson, MD
Curriculum Vitae • Click on names to view CVs: • David P. Walling, Ph.D. CEO and PI – CNS Network, LLC • Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS Network, LLC • OmidOmidvar, M.D. PI – CNS Network, LLC • Nirav S. Patel, M.D. PI – CNS Network, LLC • Steven Reynolds, D.O. PI – CNS Network, LLC • Mark Leibowitz, M.D. – PI – CNS Network, LLC • Ira D. Glick, M.D.PI – Pacific Research Partners, LLC • Donald J. Garcia, M.D. President and PI – FutureSearch Clinical Trials, LP • 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 • Joanne Northcutt, Ph.D. PI – Florida Clinical Research Center, LLC
Site Highlights • 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 and sleep indications • Fulltime certified psychometric and clinical raters – M.D., Ph.D. and M.A.-level with 3-10+ years rating experience • Multiple fulltime study coordinators including CCRCs, RNs, and LVNs • Dedicated recruitment specialists with established referral networks in their communities • Regulatory, QA, training and IT personnel
Specialized Capabilities and Experience • Dedicated 25,000 sq ft Clinical Pharmacology Unit in Long Beach, CA • Cardiac telemetry and holter monitoring • QTc and TQT • EEG and qEEG • Evoked potentials • Extensive PK sampling • Imaging: 3T MRI Scanner capable of 3.0 Tesla fMRI procedures • 64-Slice PET/CT system • Lumbar puncture and CSF collection • PSG (polysomnography) • IV infusion, oral, device, and transdermal patch delivery systems
Phase I-IV Trial Experience • Psychiatry • Addictions – smoking cessation, alcohol dependence, and binge eating • ADHD – adult and child, including classroom ADHD studies • 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, cognition, negative symptoms, stable • Pediatric psychiatry • Neurology • Alzheimer’s – MCI, mild-to-moderate, prodromal, and severe • Pain – chronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgia • Parkinson’s – early stage to advanced • Post-stroke • Multiple Sclerosis – relapsing remitting • Sleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea • General Medical • COPD, asthma, hypercholesterolemia, hypertension, obesity, type 2 diabetes, women’s health
Recruitment and Retention • Recruitment • Full time dedicated recruitment and outreach specialists on staff • Large site databases accumulated over 13+ years of research across all indications • Affiliated PI physician 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 – outreach specialists provide free seminars, lunch and learns, distribute flyers and posters • History of successful print, web, radio, and television advertising – recruitment departments have established relationships with media buyers for discounted advertising rates and 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 contact with patient and family • Reminder and follow-up phone calls • Many of the study patients are treated in the PIs and Sub-Is practices allowing for ease in transition, follow up and retention
Affiliated Practices • Affiliated Medical Practices • Collaborative Neuroscience Network is aligned with largest psychiatry, neurology and family group practices in the LA and Orange County regions.Pacific Research Partners has exclusive relationship with largest mental health clinics in the San Francisco Bay Area. • FutureSearch Trials in Austin is aligned with Neurologist/Sleep Medicine PI, Dr. Hudson’s large sleep medicine practice and sleep lab on premises of research facility. FutureSearch Trials in Dallasaligned with Dr. Downing‘s psychiatric practice. Both Austin and Dallas have community referral relationships with residential facilities and mental health agencies. • Florida Clinical Research Center is aligned with Child Psychiatrist PI, Dr. Jose Zaglul. Child and Adult Psychiatrist Jose T. Zaglul, MD has joined Florida Clinical Research Center in a fulltime capacity while continuing to maintain his professional relationship with a large community mental health system in Bradenton, FL where he has been Chief Medical Officer for many years. He is now Medical Director for Florida Clinical Research Center and the primary PI for all inpatient studies and several outpatient studies.
Alliance Advantages and Expertise • Central IRB • Responsiveness and ease of single point of contact with site relations team for rapid turnaround on site selection coordination and communications • Dedicated regulatory and budget and contract staff for quick turnaround times • Collaborative relationship with many CROs, including partnerships for monitoring and data management capabilities, if requested • Share best clinical and operational practices across sites • Site-based internal training programs • Publications and advisory board memberships • Clinical feedback and protocol consulting during development process, if needed • Affiliation with full-service, boutique CRO for any combination of the following: protocol writing, data management, statistical analysis, vendor coordination, monitoring, general study management - can be utilized for stand-alone services or as sub-contractor to clinical trial site
Preferred Relationships with Sponsors and CROs • Protocol review • Pre-feasibility assessment • Budget estimates • Master agreements in place • Rapid start-up and first-patient-in
Rating Scale Experience: Certified, experienced raters, including M.D., Ph.D. and M.A.-level
Sponsor Relations Team • Jeanette Caruso • Finance Manager Bobbie Theodore Alliance Director clinicaltrials@btheodore.com (866) 669-0234 Annie Speno Operations Manager Expedited feasibility and budget/contract negotiation handled by single point of contact with Sponsor Relations Team. Our team is responsible for handling the business development needs of the group, sponsor and CRO relations, facilitating the site selection process (CDAs, feasibility questionnaires, CVs, site capabilities information), budgets and contracts, keeping in regular contact for feedback and garnering new study opportunities so the site personnel can focus on their studies in process. There is no charge to sponsors or CROs for these services.
