Transcript Title of Presentation - Clinical Trial Centers
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 post marketing 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 - C ALIFORNIA
CNS, LLC Clinical Pharmacology Unit: 2600 Redondo Avenue, Suite 500, Long Beach, CA 90806
50+ bed CPU – targeted healthy subjects, CNS, stable psychiatry, neurology, pain, medical and bridging patient populations
20+ bed Licensed Psychiatric Hospital
(JCAHO accredited) – acute psychiatry patient populations Outpatient offices – neurology, pain, and medical patient populations
Principal Investigators: David Walling, PhD, (CEO) Psychologist Mark Leibowitz, MD, (Early Phase Medical Director) Internist Armen Goenjian, MD, (Medical Director) Psychiatrist Omid Omidvar, MD, Neurologist Nirav Patel, MD, Neurologist Steven Reynolds, DO, Family Practitioner
www.clinicaltrialcenters.com
Alliance Facilities - C ALIFORNIA
CNS, LLC Outpatient psychiatry offices: 12772 Valley View Street, Suite 3, Garden Grove, CA 92845 Principal Investigator: David Walling, PhD 19401 S. Vermont Avenue, Suite F-100, Torrance, CA 90502 Principal Investigator: Armen Goenjian, MD
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Alliance Facilities - C ALIFORNIA
Pacific Research Partners, LLC 1611 Telegraph Avenue, Suite 1550, Oakland, CA 94612 (San Francisco Bay area) Principal Investigators: Ira Glick, MD, Psychiatrist and Anand Mehta, MD, Double Boarded in Internal Medicine and Endocrinology
Inpatient –psychiatric patient population trials conducted at nearby leased psychiatric facility Outpatient – psychiatry, cognition, MCI, fibromyalgia, pain, and general medical patient population trials
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Alliance Facilities - T EXAS
FutureSearch Trials, LP 5508 Parkcrest Dr., Ste. 300, Austin, TX 78731 Principal Investigators: Donald J. Garcia, Jr., MD, (President) Psychiatrist and John D. Hudson, MD, Double Boarded in Neurology and Sleep Medicine
Inpatient and Outpatient – child - adult psychiatry including phase I special patient population trials Inpatient 6 bed sleep lab for PSG and sleep trials Outpatient – sleep, neurology, pain and general medical patient population trials
5445 La Sierra Drive, Suite 101, Dallas, TX 75231 Principal Investigator: Michael Downing, MD, Psychiatrist
Inpatient – adult psychiatry population trials Outpatient – child – adult psychiatry, Alzheimer's, cognition, insomnia, pain and some general medical patient population trials
www.clinicaltrialcenters.com
Alliance Facilities - F LORIDA
Florida Clinical Research Center, LLC 8043 Cooper Creek Blvd., Suite 107, Bradenton, Florida 34201 Principal Investigators: Andrew J. Cutler, MD, (CEO) Double Boarded in Psychiatry and Internal Medicine, Jose T. Zaglul, MD, Psychiatry, and A. Jothivijayarani, MD, Obstetrics and Gynecology
Inpatient – adult psychiatry, including targeted special phase I patient population trials Outpatient – child – adult psychiatry, cognition, insomnia, pain, and general medical patient population trials
2300 Maitland Center Pkwy, Ste. 230, Maitland, FL 32751 Principal Investigators: Martin S. Kane, MD, Board Certified Psychiatry and Neurology, Richard D. Knapp, DO, Board Certified Psychiatry and Addictions, and Joanne L. Northcutt, PhD, Child Health Psychologist
Inpatient –psychiatry population trials, pediatric - adult Outpatient – child – adult psychiatry, cognition, insomnia, and pain patient population trials
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, Endocrinology, Obstetrics and Gynecology, and Licensed Clinical Psychologists Protocol consultants to sponsors and CROs, and thought leaders in psychiatry, neurology, and 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
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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, serial 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
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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, stable, cognitive dysfunction, negative symptoms Pediatric psychiatry
Neurology
Alzheimer’s – MCI, prodromal, mild, moderate, and severe Multiple Sclerosis – relapsing remitting Parkinson’s – early stage to advanced Post-stroke, Traumatic brain injury 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
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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 (psychiatry, neurology, family practice, specialty medical, OBGYN) 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 follow up phone calls, and thorough pre-screening Many of the study patients are treated in the Investigator’s practices allowing for ease in transition, follow up, and retention
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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, and Dr. Mehta’s Bay Area Medical group practice.
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., and Dr. Jothi’s women’s health group practice
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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
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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 enrollment.
[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
Phase I Healthy Japanese Bridging Study Sponsor
[ Dr. Mark Leibowitz CNS] Congratulations on getting this study initiated so quickly! I heard that all eight subjects were successfully dosed today. Thank you for your hard work to achieve this milestone under such stringent timelines. We appreciate it greatly.
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Testimonials
Phase I Schizophrenia Study Sponsor
We have been extremely pleased with “rescue” site for our phase I schizophrenia study. We will use you again for any new early phase opportunities we have.
Dr. [David] Walling’s [CNS] sites performance as a
Phase I Schizophrenia Study CRO
I wanted to extend an extra special thank you to your your help today we could not have achieved the soft lock milestone. The entire team came together to meet our deliverable. Your staff stayed late on Wednesday (before coordinator’s jury duty), organized the team today and helped with last minute queries. Again, thanks for your continued hard work on the project and it’s been a pleasure to work with the team. Thanks. [Dr. David Walling ][CNS] team. Without
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.
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.
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Testimonials
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.
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!
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Testimonials
Migraine Study Sponsor
Dr. [Eduard] Gfeller [Florida Clinical Research Center] and in the XXX adult migraine study.
Dr. [Omid] Omidvar [CNS] have received Elite enrollment site acknowledgement (Elite Enroller Badge) for their participation
Migraine Study Sponsor
Dr. [John] Hudson and FutureSearch Trials of Neurology] the XXX study team appreciates your efforts to reduce screen failures for this study. Currently, you have the lowest SF rate out of 40 US sites and the most randomized patients. XXX appreciates your efforts and expertise in this clinical trial.
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!
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Psychiatry Sample Metrics
Study Title
A Phase II, 12 Week Randomized, Double-blind, Placebo controlled, Parallel Group, Multiple Dose, Proof-of-Concept Study to Evaluate the Effects of XXX on
Cognition in Stable Schizophrenia Patients
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
A Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with
Generalized Anxiety Disorder
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 A Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with
Bipolar I Disorder # of Patients Screened
66
# of Patients Randomized
41 40 43 58 23 28 22 45 16
Length of Enrollment
10 month (
across 2 sites
) 1 month 6 months (across 2 sites) 2 months 9 months 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
Year
2013 2013 2013 2011
Status
Closed Closed Closed Closed 2011 2010 TOP ENROLLING SITE Closed
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Phase I Sample Metrics
Study Title
A Phase I, Prospective, Randomized, Double-blind, Placebo controlled, Sequential-cohort, Escalating, Single-dose Study designed to determine the maximum tolerated oral dose of XXX in
Healthy, Male
volunteers – 3 days/2 overnights 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) 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
A Phase I,
Inpatient
Multicenter, Open-Label Study to Determine the Effects of XXX on
Sleep in Healthy Subjects # of Patients Screened
Contracted for 5 cohorts of 12 (60) Screened 110 62
# of Patients Randomized
enrolled 60 (5 cohorts of 12) plus back up pts
Length of Enrollment
5 months 40 8 months 54 26 20 (SFs due to pts not having a migraine in req’d window) 13 8 months 5 months
Year
2013 2014 2012 2012 2012 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) A Phase I, Randomized, Double-Blind, Placebo-Controlled, Combined
Single Ascending Dose and Multiple Ascending Dose Study
and Pharmacokinetics of
Intravenous Infusions
to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, of XXX in Subjects With
Mild to Moderate Alzheimer’s Disease
38 Study design 5 cohorts; 1 pt/cohort from ea site 22 20 patients enrolled (2 cohorts of 10 each)
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6 weeks
(across 2 sites)
12 months 2011 2012 2013
Status
Closed Closed TOP ENROLLING SITE TOP ENROLLING SITE TOP ENROLLING SITE TOP ENROLLING SITE
Neurology Sample Metrics
Study Title
A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of XXX in
Pediatric Patients (Ages 6-12) with Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom
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) 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
Relapsing-Remitting Multiple Sclerosis
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)
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
# of Patients Screened
12
# of Patients Randomized
11
Length of Enrollment
2 weeks 15 7 32 11 10 6 27 10 14 months 2 weeks 5 months 1 month
Year
2014 2013 2012 2010
Status
ADD ON SITE Closed 2013 TOP ENROLLING SITE Closed Closed RESCUE SITE
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Pain Sample Metrics
Study Title
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 Non-neuropathic Pain
A Phase III, Double-blind, Randomized, Placebo-controlled, Safety and Efficacy Study of Once Daily Controlled Release XXX in the Treatment of Patients with
Assessments, and Diary) Fibromyalgia
(13-week single and double blind phases, outpatient study including
Actigraphy, PK, Multiple Psychiatric, Sleep & Pain
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 Non-cancer Pain # of Patients Screened
22 49 28 14
# of Patients Randomized
20 33 24 12 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
A Six Month Phase II/III, Randomized, Double-Blind, Placebo Controlled 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
Length of Enrollment
3 months 7 months 3 months 2 months 3 months
(across 2 sites)
Year
2012 2011 2011 2010 2010
Status
Closed TOP ENROLLING SITE TOP ENROLLING SITE Closed Closed
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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 Anand Mehta, 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 A. Jothi, 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