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Clinical Trial Centers Alliance. Presented August 2012 Bobbie Theodore Alliance Director 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

Clinical Trial Centers Alliance

Presented August 2012

Bobbie Theodore

Alliance Director

Clinical trial centers alliance

Alliance facilities california
Alliance Facilities - Florida comprise the AllianceCalifornia

  • 25,000 sq ft dedicated Clinical Pharmacology Unit for inpatient psychiatry and inpatient / outpatient CNS and medical trials

    • 50 bed unit, private and semi-private rooms for phase I CNS and medical special patient populations, healthy and ethno-bridging

    • 14 bed licensed psychiatric health care unit for psychiatry special patient populations

      Garden Grove, and Torrance, CA

  • Outpatient psychiatry

  • Collaborative Neuroscience Network, Inc.

    Long Beach, CA - Click here for a video of the phase I unit

  • Pacific Research Partners, LLC

    San Francisco area, CA

    • Inpatient and outpatient psychiatry (10 beds with flexible capacity)

Alliance facilities texas
Alliance Facilities - Florida comprise the AllianceTexas

  • 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

      Dallas, TX

    • Inpatient and outpatient psychiatry (10 beds with flex capacity)

    • Outpatient Alzheimer's disease, cognitive dysfunction, pain, and insomnia

Alliance facilities florida
Alliance Facilities - Florida comprise the AllianceFlorida

  • Affiliate sleep lab for inpatient phase I healthy subjects, sleep disorders (PSG), and general medical specialty populations (14 rooms can accommodate up to 6 beds each for large cohorts)

  • Florida Clinical Research Center, LLC

    Bradenton, FL

    • Inpatient and outpatient psychiatry, pediatric - adult (10 beds with flexible capacity)

    • Outpatient general medicine, pain, and women’s health

      Maitland, FL

    • Inpatient and outpatient psychiatry, pediatric – adult (30 beds with flex capacity)

    • Outpatient Alzheimer’s,general medicine and pain

Clinical trial centers alliance


David Walling, PhD ArmenGoenjian, MD Omid Omidvar, MD Nirav Patel, MD Steven Reynolds, DO Ira Glick, MD

Donald Garcia, MD John D. Hudson, MD Michael Downing, MD

Andrew Cutler, MD Eduard Gfeller, MD Richard Knapp, DO Joanne Northcutt, PhD Jose Zaglul, MD Marissa Magsino, MD

Curriculum vitae
Curriculum Vitae CALIFORNIA

  • Click on names to view CVs:

    • David P. Walling, Ph.D. CEO and PI – CNS Network, Inc.

    • Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS Network, Inc.

    • OmidOmidvar, M.D. PI – CNS Network, Inc.

    • Nirav S. Patel, M.D. PI – CNS Network, Inc.

    • Steven Reynolds, D.O. PI – CNS Network, Inc.

    • 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

    • Eduard Gfeller, M.D. 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

    • Marissa E. Magsino, M.D. PI – Florida Clinical Research Center, LLC

Site highlights
Site Highlights CALIFORNIA

  • 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

    • Seasoned certified psychometric and clinical raters – M.D., Ph.D. and M.A.-level with 3-10+ years rating experience

  • Multiple fulltime study coordinators including CRCs, RNs, and LVNs

  • Recruitment specialists with established referral networks in their communities

  • Regulatory, QA, training and IT personnel

Specialized capabilities and experience
Specialized Capabilities and Experience CALIFORNIA

  • 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

  • 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
Phase I-IV Trial Experience CALIFORNIA

  • 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 and Retention CALIFORNIA

  • Recruitment

    • Full time dedicated recruitment and outreach specialists

    • Large site databases accumulated over 11+ 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, providing free seminars, lunch and learns, and distributing flyers

    • History of successful print, web and radio advertising

    • Ability to pre-qualify patients via IRB-approved pre-screen consent form

  • Retention

    • Inpatient facilities have private rooms and can accommodate caregivers 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 Practices CALIFORNIA

  • Affiliated Medical Practices

    • CNS 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. Zaglul’s large psychiatry group practice in Bradenton, FL and Internist PI Dr. Magsino’s private practice in the Orlando area.

Alliance advantages and expertise
Alliance Advantages and Expertise CALIFORNIA

  • Central IRB for all sites

  • Responsiveness and ease of single point of contact with site relations team for rapid turnaround on start-up

  • Quick turnaround times on regulatory and budgets and contracts

  • 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

Preferred relationships with sponsors and cros
Preferred Relationships with Sponsors and CROs CALIFORNIA

  • Protocol review

  • Pre-feasibility assessment

  • Budget estimates

  • Master CDAs and agreements in place

  • Rapid start-up and first-patient-in

Rating scale experience
Rating CALIFORNIAScale Experience:

Certified, experienced raters, including M.D., Ph.D. and M.A.-level

Phase i special populations sample metrics
Phase I Special Populations CALIFORNIASample Metrics

Phase i special populations sample metrics cont d
Phase I Special Populations CALIFORNIASample Metrics (cont’d)

Phase iia special populations sample metrics
Phase CALIFORNIAIIa Special Populations Sample Metrics

Adhd sample metrics cont d
ADHD Sample Metrics ( CALIFORNIAcont’d)

Pain sample metrics cont d
Pain Sample Metrics ( CALIFORNIAcont’d)

Database s by indication cont d
Database #s By Indication ( CALIFORNIAcont’d)

Clinical trial centers alliance

Database #s By Indication ( CALIFORNIAcont’d)

Database s by indication cont d1
Database #s By Indication ( CALIFORNIAcont’d)

Sponsor relations team
Sponsor Relations Team CALIFORNIA

  • Jeanette Caruso

  • Finance Manager

Bobbie Theodore

Alliance Director

(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 .