Transcript Title of Presentation

Clinical Trial Centers Alliance
offering specialized expertise to fit the unique
needs of each client
Bobbie Theodore
Alliance Director
[email protected]
www.clinicaltrialscenters.com
Executive Summary
Our Alliance of experienced research sites and services can address
portfolio clinical research needs. We propose flexible options to serve
your clinical development needs as follows:
A menu of services under one liaison and contract
Expertise across a range of therapeutic areas, phase I through postmarketing
Integrated services including clinical site conduct, with or without
bundled CRO services such as protocol development, trial management,
data management, statistical analysis, monitoring – any or all to meet
your clinical program needs
www.clinicaltrialcenters.com
Independent (Non-SMO) entities in California, Texas and Florida
comprise the Alliance
Combined 1,000+ clinical trials conducted, phases I-IV
Central IRB
Large patient databases, affiliated medical practices and proven
recruitment methods
Alliance Facilities - CALIFORNIA
CNS, LLC
Long Beach, CA – 25,000 sq ft Clinical Pharmacology Unit and Licensed Psychiatric Hospital
PI’s: David Walling, PhD, CEO, Mark Leibowitz, MD, Early Phase Medical Director, Armen
Goenjian, MD, Medical Director, Omid Omidvar, MD, Nirav Patel, MD, Steven Reynolds, DO
Dedicated 60+ Bed Phase I Unit – stable psychiatric,
CNS, targeted healthy normal volunteers, medical and
ethno-bridging special patient population trials
Dedicated 20 Bed Psychiatric Health Facility – licensed
psychiatric health care unit, private and semi-private
rooms - inpatient acute psychiatric population trials
Outpatient Offices – neurology, pain, and general
medical population trials
Garden Grove, CA – Outpatient psychiatry offices – PI: David Walling, PhD
Torrance, CA – Outpatient psychiatry - PI: Armen Goenjian, MD
www.clinicaltrialcenters.com
Alliance Facilities - CALIFORNIA
Pacific Research Partners, LLC
San Francisco area, CA – Principal Investigator: Ira Glick,
MD
Inpatient - psychiatry patient population trials
Outpatient – psychiatry, cognition, MCI, pain
population trials
www.clinicaltrialcenters.com
Alliance Facilities - TEXAS
FutureSearch Trials, LP
Austin, TX – PI’s: Donald Garcia, Jr., MD, President, and
John Hudson, MD
Inpatient and Outpatient - psychiatry including
phase I special population trials, pediatric - adult
Inpatient - 6 bed sleep lab for PSG and sleep trials
Outpatient – sleep, neurology, Alzheimer’s and pain
population trials
Dallas, TX – PI: Michael Downing, MD
Inpatient - psychiatry (10 beds with flex capacity)
population trials, pediatric - adult
Outpatient – psychiatry, Alzheimer's disease,
cognitive dysfunction, pain, and insomnia population
trials
www.clinicaltrialcenters.com
Alliance Facilities - FLORIDA
Florida Clinical Research Center, LLC
Bradenton, FL – PI’s: Andrew Cutler, MD, CEO, and Jose
Zaglul, MD
Inpatient - psychiatry, including targeted special phase
I population trials, pediatric - adult
Outpatient – psychiatry, cognitive dysfunction,
insomnia, and pain population trials
Maitland, FL – PI’s: Martin Kane, MD, Richard Knapp, DO,
and Joanne Northcutt, PhD
Inpatient – psychiatry population trials, pediatric - adult
Outpatient – psychiatry, cognitive dysfunction,
insomnia, and pain population trials, pediatric - adult
www.clinicaltrialcenters.com
Staff Highlights
Each Research Site Has 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, sleep
indications and phase I study designs
Fulltime certified psychometric clinical raters – M.D., Ph.D. and M.A.-level with up
to 20+ years rating experience
Multiple fulltime study coordinators
including CCRCs, RNs, and LVNs
Dedicated recruitment and outreach
specialists with established referral networks
in their communities
Regulatory, QA, training and IT personnel
www.clinicaltrialcenters.com
Specialized Capabilities and
Experience
Dedicated Clinical Pharmacology Unit (CPU) in Long Beach, CA
Healthy subjects, and special patient populations
Cardiac, telemetry and holter monitoring
QTc and TQTc
EEG and qEEG
Evoked potentials
Serial PK and ECG
1.5 and 3T MRI, fMRI bold and 64-Slice PET/CT system imaging
Lumbar puncture and CSF collection
PSG (polysomnography)
Infusion, injection, oral, device, and transdermal patch delivery
systems
www.clinicaltrialcenters.com
Phase I-IV Trial Experience
Psychiatry
Addictions – smoking cessation, alcohol dependence, binge eating
ADHD – adult and child, including classroom ADHD
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, cognitive dysfunction, negative symptoms,
stable
Pediatric psychiatry
Neurology
Alzheimer’s – MCI, prodromal, mild, moderate, and severe
Parkinson’s – early stage to advanced
Post-stroke
Multiple Sclerosis – relapsing remitting
Sleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea
Pain
Chronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgia
General Medical
COPD, asthma, hypercholesterolemia, hypertension, obesity, OIC, type 2 diabetes, women’s health
www.clinicaltrialcenters.com
Recruitment and Retention
Recruitment
Full time dedicated recruitment and outreach specialists on staff
Large databases accumulated over 13+ years of research across all indications
Affiliated PI physician private and group 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 – provide free seminars, lunch and learns
History of successful print, web, radio, and television advertising – recruitment departments have
established relationships with media buyers for discounted advertising rates and preferred
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 communication with patient and family, reminder and followup phone calls
Many of the study patients are treated in the Investigator’s practices allowing for ease in
transition, follow up, and retention
www.clinicaltrialcenters.com
Affiliated Practices
Affiliated Medical Practices
CNS, CA is aligned with Drs. Goenjian, Omidvar, Patel and Reynolds large
psychiatry, neurology and family group practices respectively in the LA and
Orange County regions.
Pacific Research Partners, CA has exclusive relationship with the largest mental
health clinics in the San Francisco Bay Area Counties.
FutureSearch Trials, Austin, TX is aligned with Dr. Hudson’s sleep
medicine/neurology practice and sleep lab on premises of research facility.
FutureSearch Trials, Dallas, TX is aligned with Dr. Downing‘s psychiatry practice.
Both Austin and Dallas sites have established community referral relationships
with several residential facilities and mental health agencies.
Florida Clinical Research Center, FL is aligned with Dr. Zaglul’s large child and
adult mental health agency and residential facilities.
www.clinicaltrialcenters.com
Alliance Advantages and Expertise
Menu of site and study management services based on sponsor need
Responsiveness and ease of single point of contact with sponsor
relations team
Dedicated regulatory/budget/contract staff for quick turnaround times
including use of Central IRB
Best clinical and operational practices shared across sites
Thought leaders in CNS and Phase I indications with multiple
publications, and advisory board memberships
Clinical, budget, and protocol feedback during development process, if
needed
Established vendor relationships for seamless execution
www.clinicaltrialcenters.com
Testimonials
CNS Sponsor
Bobbie, we will likely initiate additional clinical trials early next year. Your team of
investigators tops our list! (Their performance on our last protocol was outstanding on all
levels.) Thank you!
Depression Study Sponsor
Dr. [Andrew] Cutler and Patricia, [Florida Clinical Research Center] YOU are NUMBER 1. My
sincere appreciation and my congratulations to you for screening the first subject in the XXX
depression study. The ice is broken and the ship has now sailed. Thank You.
Depression Study Sponsor
Dr. [Donald] Garcia’s [FutureSearch Clinical Trials] site consistently came out excellent on rater
performance as monitored by our vendor. They have also helped us get ahead of schedule on
enrollment.
Phase I Schizophrenia Study Sponsor
We have been extremely pleased with Dr. [David] Walling’s [CNS] sites performance as a
“rescue” site for our phase I schizophrenia study. We will use you again for any new early
phase opportunities we have.
Schizophrenia Study Sponsor
Dr. [David] Walling’s [CNS] site has been selected for our new schizophrenia trial because they
do excellent work, and they were specifically selected for a high-profile schizophrenia trial
based on a detailed statistical analysis by the study team of past placebo response rates.
www.clinicaltrialcenters.com
Testimonials
Alzheimer’s Study Sponsor
Good afternoon Dr. [Omid] Omidvar, [CNS], I am writing to invite you to participate in a Phase
IIb Alzheimer’s trial. You and your team were one of the top enrolling sites for the XXX Elderly
MRD trial and we think that you and your team could be perfect for the trial.
ADHD Study Sponsor
Dr. [Andrew] Cutler, Patti, and Florida Clinical Research Center staff have been wonderful
throughout their work on our studies. The team exceeded their enrollment goal and closed the
study with a remarkably low screen failure and early discontinuation rate. In addition, and the
quality of their work on both studies has been exceptional – their source and CRF data have
been clean resulting in cost and time savings for our monitoring and data management
activities. Dr. Cutler has also been incredibly helpful by collaborating with our team on patient
recruitment strategies, the appropriate use of our study diagnostic tool, and sharing his
thoughts about future development work with the compound.
ADHD Study Sponsor
I wanted to let you know what a nice job Dr. [Donald] Garcia’s [FutureSearch Clinical Trial] site
has done in our adult ADHD trial. He is our highest recruiter by far! Very knowledgeable and
good work. He will be on our upcoming studies as you are aware.
Multiple Sclerosis Study CRO
Dr. [Omid] Omidvar, [CNS], your pace of screening and randomizing patients over the last
couple months is impressive. We need to clone your site J. Thank you.
www.clinicaltrialcenters.com
Testimonials
Multiple Sclerosis Study Sponsor
Hi all, XXX (Senior Director of Clinical Operations with XXX) came by to meet with Dr. [Nirav]
Patel, Anne Cabral, and the [CNS] team to acknowledge the outstanding job we all did on the
XXX (MS) spasticity study! According to some of his internal metrics, we were performing at
300+% compared to other sites. That is amazing!
Migraine Study Sponsor
Dr. [Eduard] Gfeller [Florida Clinical Research Center] and Dr. [Omid] Omidvar [CNS] have
received Elite enrollment site acknowledgement (Elite Enroller Badge) for their participation
in the XXX adult migraine study.
Pain Study Sponsor
Please pass my gratitude on to Dr. [John] Hudson and [FutureSearch Trials of Neurology] staff
as they have really knocked a good many missing pages out (before deadline), I am very
impressed. Other sites were not close to meeting this deadline. Please share my gratitude
with Dr. Hudson next time you speak to him. I know Adam put a lot of time into this and it
should not go unsung. Thank you.
Insomnia Sleep Sponsor
Dear Dr. [John] Hudson, [FutureSearch Trials of Neurology], I hope you are doing well. I was
reviewing the XXX-sponsored trial enrollment numbers in my region, and was impressed with
your enrollment numbers in the PSG study. I just wanted to say thank you so much for all of
the hard work by you and your staff!
www.clinicaltrialcenters.com
Psychiatry Sample Metrics
# of Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Year
Status
A Phase II, 12 Week Randomized, Double-blind, Placebocontrolled, Parallel Group, Multiple Dose, Proof-of-Concept
Study to Evaluate the Effects of XXX on Cognition in Stable
Schizophrenia Patients
66
41
10 month
2013
Closed
A Phase I, Open-label, Multiple Dose, Safety and Tolerability
Study of XXX IM Depot Administered in the Deltoid Muscle in
Adult Subjects with Schizophrenia
40
28
1 month
2013
Closed
A Double-Blind, Placebo-Controlled, Flexible-Dose Study
of XXX in Patients with Generalized Anxiety Disorder
43
22
6 months
(across 2 sites)
2013
Closed
A Phase IV, Multi-national, Randomized, Double-blind,
Placebo-controlled Study to Evaluate the Efficacy and
Safety of XXX compared to Placebo for Smoking
Cessation Through Reduction
58
45
2 months
2011
Closed
A Phase III, Long-Term Open-Label Study of the Safety
and Tolerability of XXX in Patients with Bipolar I Disorder
23
16
9 months
2011
TOP
ENROLLING
SITE
A Phase III, Double-Blind, Randomized, Multi-Center,
Placebo-Controlled, Relapse Prevention Study with XXX
in Out-Patient Adults with Major Depressive Disorder
32
24
3 months
2010
Closed
Study Title
(across 2 sites)
www.clinicaltrialcenters.com
Phase I Sample Metrics
# of Patients
Screened
# of Patients
Randomized
Length of
Enrollment
A Phase I, Prospective, Randomized, Double-blind, Placebocontrolled, Sequential-cohort, Escalating, Single-dose Study
designed to determine the maximum tolerated oral dose of
XXX in Healthy, Male volunteers – 3 days/2 overnights
Contracted
for 5 cohorts
of 12 (60)
enrolled 60 (5
cohorts of 12)
A Phase I, 2-part, Open Label, Inpatient Study to Assess the
Safety and Tolerability of Multiple Ascending Doses of XXX in
Subjects with Schizophrenia (Extensive PKs & multiple ECGs)
62
Phase I, Inpatient Open-Label, Randomized, Parallel Group,
Crossover Study to Compare the Pharmacokinetcs of XXX in
Migraine Subjects During an Acute Migraine Attack and During
a Non-Migraine Period
Study Title
Year
Status
5 months
2013
2014
Active – 1
site
40
8 months
2012
Closed
54
20 (SFs due to
pts not having a
migraine in
req’d window)
8 months
2012
TOP
ENROLLING
SITE
A Phase I, Inpatient Multicenter, Open-Label Study to
Determine the Effects of XXX on Sleep in Healthy Subjects
26
13
5 months
2012
TOP
ENROLLING
SITE
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of
Safety and Pharmacodynamic Effects of XXX in Major Depressive
Disorder Subjects (Extensive PKs & multiple ECGs)
38
22
6 weeks
(across 2
sites)
2011
TOP
ENROLLING
SITE
Study design
5 cohorts;
1 pt/cohort
from ea site
20 patients
enrolled (2
cohorts of 10
each)
12 months
2012
2013
TOP
ENROLLING
SITE
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Combined
Single Ascending Dose and Multiple Ascending Dose Study to Assess
Safety, Tolerability, Immunogenicity, Pharmacodynamic Response,
and Pharmacokinetics of Intravenous Infusions of XXX in Subjects
With Mild to Moderate Alzheimer’s Disease
Screened 90
www.clinicaltrialcenters.com
Neurology Sample Metrics
# of Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Year
Status
A Phase III, Randomized, Double-blind, Placebo-Controlled
Study of the Safety and Effectiveness of XXX for the
Treatment of Mild to Moderate Alzheimer’s Disease
(includes IGIV, and infusion)
15
10
14 months
2013
TOP
ENROLLING
SITE
An Open-Label, Randomized, Multi-Center, Parallel-Arm
Study to Assess the Safety and Tolerability of XXX 40 mg/mL
Three Times a Week Compared to 20 mg/mL Daily
Subcutaneous Injections in Subjects with RelapsingRemitting Multiple Sclerosis
7
6
2 weeks
2013
Closed
Pilot Epilepsy Study to Evaluate a Baseline Prototype Device
Designed to Collect ECG (Electrocardiogram) and
Accelerometer Data
5
5
6 months
2013
Closed
A Phase II, Double-blind, Randomized, Placebo-controlled,
Multicenter, Fixed-dose, Study to Assess Efficacy, Safety and
Tolerability of XXX in Adults with Inattentive-Predominant
Attention Deficit/ Hyperactivity Disorder (ADHD)
32
27
5 months
2012
Closed
A Phase IIa Randomized, Double-Blind, Cross over Study
Comparing the Tolerability of Two Dose Regimens of XXX in
Adult Patients with Parkinson's Disease who are receiving
XXX
11
10
1 month
2010
RESCUE
SITE
Study Title
www.clinicaltrialcenters.com
Pain Sample Metrics
# of Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Year
Status
A Phase III, Open-Label, Multicenter Study to Assess the Long
-Term Safety of XXX Once-Daily in Subjects with Moderate to
Severe Chronic Nonmalignant and Nonneuropathic Pain
22
20
3 months
2012
Closed
A Phase III, Double-blind, Randomized, Placebo-controlled,
Safety and Efficacy Study of Once Daily Controlled Release XXX
in the Treatment of Patients with Fibromyalgia (13-week
single and double blind phases, outpatient study including
Actigraphy, PK, Multiple Psychiatric, Sleep & Pain
Assessments, and Diary)
49
33
7 months
2011
TOP
ENROLLING
SITE
A Phase III, Multicenter, 12-Month, Open-Label, Single-Arm,
Safety Study of XXX and XXX Extended-Release Capsules in
Subjects With Moderate to Severe Chronic Noncancer Pain
28
24
3 months
2011
TOP
ENROLLING
SITE
A Phase III, Safety and Tolerability Study Comparing XXX Given
as an Oral Solution to a Single-blinded Combination of Oral
Tablets plus Oral Solution in Subjects with Fibromyalgia
14
12
2 months
2010
Closed
A Six Month Phase II/III, Randomized, Double-Blind, PlaceboControlled Clinical Trial to Evaluate the Safety, Tolerability,
and Efficacy of XXX for Prevention of Menstrually Related
Migraine in Female Patients with Episodic Migraine
42
41
3 months
(across 2
sites)
2010
Closed
Study Title
www.clinicaltrialcenters.com
Curriculum Vitae
Click on PI names to view CVs:
David P. Walling, Ph.D. CEO and PI – CNS, LLC
Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS, LLC
Omid Omidvar, M.D. PI – CNS, LLC
Nirav S. Patel, M.D. PI – CNS, LLC
Steven Reynolds, D.O. PI – CNS, LLC
Mark Leibowitz, M.D. – PI – CNS, 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
Martin Kane, M.D. PI – Florida Clinical Research Center, LLC
www.clinicaltrialcenters.com
Contact
For further information on Alliance
services contact:
Bobbie Theodore
(916) 939-6696
[email protected]
www.clinicaltrialcenters.com
www.clinicaltrialcenters.com