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Executive Summary Clinical Trial Centers Alliance

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 Summary Clinical Trial Centers Alliance

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  1. Executive SummaryClinical Trial CentersAlliance Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Phase I Special Populations Sample Metrics

  10. Phase I Special Populations Sample Metrics (cont’d)

  11. Phase IIa Special Populations Sample Metrics

  12. Phase IIa Special Populations Sample Metrics (cont’d)

  13. Cognition in Schizophrenia and Schizophrenia Sample Metrics

  14. Cognition in Schizophrenia and Schizophrenia Sample Metrics (cont’d)

  15. Bipolar Sample Metrics

  16. Depression Sample Metrics

  17. ADHD Sample Metrics *Top enrolling sites

  18. ADHD Sample Metrics (cont’d)

  19. Anxiety Sample Metrics

  20. Neurology and Pain Sample Metrics

  21. Alzheimer’s Sample Metrics

  22. Sleep and RLS Sample Metrics

  23. Curriculum Vitae

  24. 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

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