Clinical trial centers alliance
This presentation is the property of its rightful owner.
Sponsored Links
1 / 46

Clinical Trial Centers Alliance PowerPoint PPT Presentation


  • 61 Views
  • Uploaded on
  • Presentation posted in: General

Clinical Trial Centers Alliance. Presented August 2012 Bobbie Theodore Alliance Director [email protected] www.clinicaltrialcenters.com. Independent (Non-SMO) entities in California, Texas and Florida comprise the Alliance Combined 500+ clinical trials conducted, phases I-IV

Download Presentation

Clinical Trial Centers Alliance

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Clinical trial centers alliance

Clinical Trial Centers Alliance

Presented August 2012

Bobbie Theodore

Alliance Director

[email protected]

www.clinicaltrialcenters.com


Clinical trial centers alliance

  • 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

Alliance Facilities - California

  • 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 - 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

      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

  • 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

FLORIDA TEXAS CALIFORNIA

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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Protocol review

  • Pre-feasibility assessment

  • Budget estimates

  • Master CDAs and agreements in place

  • Rapid start-up and first-patient-in


Rating scale experience

Rating Scale Experience:

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


Phase i special populations sample metrics

Phase I Special Populations Sample Metrics


Phase i special populations sample metrics cont d

Phase I Special Populations Sample Metrics (cont’d)


Phase iia special populations sample metrics

Phase IIa Special Populations Sample Metrics


Adhd sample metrics

ADHD Sample Metrics


Adhd sample metrics cont d

ADHD Sample Metrics (cont’d)


Alzheimer s sample metrics

Alzheimer’s Sample Metrics


Anxiety sample metrics

Anxiety Sample Metrics


Bipolar sample metrics

Bipolar Sample Metrics


Depression sample metrics

Depression Sample Metrics


Pain sample metrics

Pain Sample Metrics


Pain sample metrics cont d

Pain Sample Metrics (cont’d)


Cognition in schizophrenia and schizophrenia sample metrics

Cognition in Schizophrenia and Schizophrenia Sample Metrics


Sleep and rls sample metrics

Sleep and RLS Sample Metrics


Placebo response data adhd

Placebo Response Data - ADHD


Placebo response data adhd1

Placebo Response Data - ADHD


Placebo response data bipolar

Placebo Response Data - Bipolar


Placebo response data gad

Placebo Response Data - GAD


Placebo response data mdd

Placebo Response Data - MDD


Placebo response data mdd1

Placebo Response Data - MDD


Placebo response data mdd2

Placebo Response Data - MDD


Placebo response data mdd3

Placebo Response Data - MDD


Placebo response data schizophrenia

Placebo Response Data - Schizophrenia


Placebo response data schizophrenia1

Placebo Response Data - Schizophrenia


Placebo response data schizophrenia2

Placebo Response Data - Schizophrenia


Placebo response data schizophrenia3

Placebo Response Data - Schizophrenia


Placebo response data schizophrenia4

Placebo Response Data - Schizophrenia


Database s by indication

Database #s By Indication


Database s by indication cont d

Database #s By Indication (cont’d)


Clinical trial centers alliance

Database #s By Indication (cont’d)


Database s by indication cont d1

Database #s By Indication (cont’d)


Sponsor relations team

Sponsor Relations Team

  • Jeanette Caruso

  • Finance Manager

Bobbie Theodore

Alliance Director

[email protected]

(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 .


  • Login