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Executive Summary Clinical Trial Centers Alliance. Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com. Site Locations . Serving large urban and suburban population areas in diversified geographic regions.
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Executive SummaryClinical Trial CentersAlliance Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com
Site Locations Serving large urban and suburban population areas in diversified geographic regions Collaborative Neuroscience Network, Inc. Garden Grove, CA - Outpatient psychiatry Torrance, CA - Outpatient psychiatry Long Beach, CA -Clinical Pharmacology Unit • Phase I healthy, psychiatry, neurology, pain, medical special patient populations, and Asian bridging San Francisco area, CA - Inpatient and outpatient psychiatry
Site Locations(cont’d) FutureSearch Trials, L.P. Florida Clinical Research Center, LLC Bradenton, FL - Inpatient and outpatient psychiatry and general medical Maitland, FL - Inpatient and outpatient psychiatry, pain, and Phase I healthy and special patient populations Austin, TX - Inpatient and outpatient psychiatry, neurology, pain, and Phase I special patient populations Dallas, TX - Inpatient and outpatient psychiatry Serving large urban and suburban population areas in diversified geographic regions
Site Highlights • Dedicated Research Sites • 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 • Inpatient and outpatient facilities, as well as a specialized clinical pharmacology unit • Fulltime Dedicated and Highly Experienced Staff • Investigators Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Osteopathic Medicine and Licensed Clinical Psychologists • Thought Leaders in Psychiatry and Sleep Disorders • CCRCs and Clinical Raters – MD, PhD and MA-level with 3-10+ years experience • Recruitment Specialists with established referral networks in their communities • Regulatory, QA, training and IT personnel • Affiliated Medical Practices • CNS Network aligned with largest Psychiatry and Neurology Group Practices in the LA and Orange County regions as well as the San Francisco Bay Area • FutureSearch Trials aligned with Dr. Hudson’s Sleep Medicine Practice and Sleep Lab on premises of research facility • Florida Clinical Research aligned with largest Psychiatry Group Practice in the region
Specialized Capabilities • 3T MRI Scanner capable of FMRI Procedures • 64-Slice PET/CT System • Cardiac Telemetry and Holter Monitoring • QTc and TQT • EEG/qEEG • Evoked potentials • Extensive PKs • Infusions • Lumbar Puncture/Continuous CSF Collection • PSG (polysomnography) • Device
Phase I-IV Trial Experience/Capabilities • Psychiatry • Schizophrenia and schizoaffective disorders - acute, negative symptoms, stable, cognition • Bipolar – mania, mixed, bipolar depression • Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction • ADHD – adult and child, including classroom ADHD studies • Cognition – in schizophrenia, mild cognitive impairment • Other indications - anxiety, PTSD, addictions, pediatric psychiatry • Neurology • Parkinson’s - early stage and advanced • Alzheimer’s – MCI, prodromal, mild-to-moderate, severe • Pain - migraine, diabetic neuropathy, osteoarthritis, chronic pain, fibromyalgia • Sleep disorders – insomnia, Restless Legs Syndrome, narcolepsy, shift worker, sleep apnea • Epilepsy - adjunctive therapy and monotherapy • General Medical • Type 2 Diabetes, NOH (hypotension), Obesity, COPD
Recruitment and Retention • Recruitment: • Full time dedicated Recruitment and Outreach Specialists • Maintain established relationships with network of physicians (Neurologists, Psychiatrists and Internists) with access to patient databases for referrals • Community Outreach includes visiting residential facilities, senior communities and community events, providing free seminars, lunch and learns, and distributing flyers • Large Site Databases and affiliated Psychiatrist’s and Neurologist’s practice databases across all indications accumulated over 10 years • Ability to pre-qualify patients via IRB-approved pre-screen consent form for queries allowing non-evasive procedures • Established relationships with Media Buyers for history of successful advertising • High Retention / Low Drop Out: • Private rooms for caregiver accommodations if needed • TVs in each room and in community areas • Wireless Internet and community computers allows patients to keep in touch • Recreation Therapist provides ongoing activities for longer inpatient stays • Dietician • Site provides patient transportation when needed • Dedicated staff for regular contact with patient and family to promote retention • Reminder and follow up phone calls • Many of the study patients are treated in PIs / Sub-Is practices allowing for ease in transition, follow up and retention
Alliance Advantages and Expertise • Responsiveness and ease of single point of contact with Site Relations Team for rapid turnaround on start-up • Budget/Contract matched for all selected PIs • Central IRB • Collaborative relationship with many CROs, including partnerships for monitoring and data management capabilities, if requested • Dedicated internal QA function at each site • Share best practices across sites • Site-based internal training programs • Publications and advisory board membership • PIs provide clinical feedback and protocol consulting during development process, if needed • Part of Pharmas and CROs site preferred partner programs • Dedicated Staff Trainer • Site-level Rater Training program
Cognition in Schizophrenia and Schizophrenia Sample Metrics (cont’d)
ADHD Sample Metrics *Top enrolling sites
Contact Info • Website: www.clinicaltrialcenters.com • For more information or to arrange a site visit, please contact Alliance Team: Bobbie Theodore – Alliance Director clinicaltrials@btheodore.com email (866) 669-0234 or (916) 939-6696 Annie Speno – Operations Manager annie@btheodore.com email 916-934-0569 phone / 866-745-8708 fax Jeanette Caruso – Site Liaison & Budgets/Contracts Manager jeanette@btheodore.com email 916-933-3023 phone / 916-933-3097 fax