Woodland International Clinical Pharmacology ... › ... › 05 › Midwest-Clinical-Research...in past 6 months in hernia and TKA surgical pain models ... Midwest Clinical Research

CORPORATE HEADQUARTERS:

Evolution Research Group12 New Providence RoadWatchung NJ 07069Ph. (908) 756-4411Fax (908) [email protected]

www.cnssites.comwww.joinaresearchstudy.comFor further information or study placement,

please call or write to: [email protected]

Study Experience:Total: 250Phase 1Phase 1b/2aProof of ConceptProof of MechanismTQT/Cardiac SafetyPhase 2b/3

Site Highlight:Unique 16 Bed CRU Specially Designed for Phase 1 and Late Phase Inpatient Studies in Pediatric Populations

Facility Highlights

Woodland International Research GroupLittle Rock, Arkansas

Woodland International Research Group, a subsidiary of Evolution Research Group, is an inpatient and outpatient research facility experienced in conducting simple and complex trials in psychiatric and neurological disorders, pain indications, addictions, sleep disorders as well as additional non-CNS indications.

• 12,000 square foot, 50-bed research facility with main unit including: • 18-bed private room unit • 10-bed PK unit with infusion capabilities • 6 bed acute care unit

• Separate purpose-built, 16-bed CRU is adjacent to the main unit, designated speci�cally for pediatric and adolescent inpatient trials in special populations

• Designed for the Comfort of Patients & Family

• State-of-the-art technology including beside TVs with video gaming, arts and crafts, gaming tables, an indoor gymnasium, other activities and secure outdoor fresh air space

• Patient retention program includes education and tutoring for school-aged study participants.

• Contract with compounding pharmacy with laminar �ow hood

• Secured outdoor smoking space

• CLIA-waived laboratory

• Dedicated monitoring rooms with high-speed internet connection (wired and wireless)

• Secure, temperature controlled, double locked drug storage room; limited access via key-fob

• Experience in long-term and short-term con�nement (90+ days)

• ACLS Certi�ed Sta� (PALS Certi�cation if Required)

• Team of highly trained neuropsychiatric raters certi�ed on multiple scales

• Multiple Separate Exam and Procedure Rooms

• Catered Meals

• Extensive experience with Serial PK draws in both adult and pediatric populations

• Well-established methods for recruitment including community outreach including Louisiana and Mississippi


Site Highlight:Coming Soon to WRN:• New 20 bed Phase 1 unit• Expanded reception/lobby area• Satellite site in Ft. Smith,

Arkansas

Facility Highlights

Woodland Research NorthwestRogers, Arkansas

Woodland Research Northwest, a subsidiary of Evolution Research Group, is an inpatient and outpatient research facility experienced in conducting simple and complex trials in psychiatric and neurological disorders, pain indications, addictions, sleep disorders as well as additional non-CNS indications in both adult and pediatric populations.

• Purpose built 12,000 square foot facility

• 24-bed inpatient unit designed for subject comfort and safety

• Each resident has his or her own TV in semi-private rooms

• Site provides laundry facilities, a full kitchen, a game room, two living areas, two controlled and secured outdoor spaces

• Indoor/Outdoor dedicated smoking area



• Nursing station centrally located for continuous monitoring

• Utilize well-established methods for recruitment including community outreach throughout northwest Arkansas and into Oklahoma and Missouri

• Located within 5 miles of 3 University campuses

• Mercy Hospital is less than 1 mile away

• Vendor partners for PET, MRI and CSF

• Adult and pediatric expertise




Site Highlight:MSA with Washington UniversityCenter for Clinical Imaging Research Collaborating on State-of-the-Art Imaging & Biomarker studies since 2016

Facility Highlights

St. Louis Clinical TrialsSt. Louis, Missouri

St. Louis Clinical Trials, a subsidiary of Evolution Research Group, is a 24-bed inpatient and outpatient research facility experienced in conducting simple and complex trials in psychiatry, neurology, addiction, sleep and pain indications, as well as healthy volunteers. SLCT conducts clinical trials in postoperative pain following bunionectomy and hernia repair. The site is associated with a local surgical center, performing surgical procedures leading to these post-surgical pain studies.

• Purpose built 24 bed clinical research unit designed speci�cally for CNS populations, including ability to accomodate complex procedures

• Designed for the comfort of patients



• Facility maintains a drug room with: a laminar �ow hood, double locked with a 24-hour monitoring system

• IATA and CLIA waived processing laboratory and -20 and -70 degree sample storage

• Two indoor smoking rooms equipped with a recirculating ventilation system

• Dedicated, controlled and secure outdoor smoking area

• Experience with topography, spirometry, CO measurements and PK biomarkers

• Team of experts in conducting Human Abuse Liability and Human Abuse Potential studies

• Dietician to provide special meals

• ACLS certi�ed sta�

• Expertise on all pain scales and subject diaries with KOL on site

• Sta� fully trained on analgesic trial methodology and placebo mitigation

• Well-established methods for recruitment including community outreach throughout the Greater St. Louis

• Procedural Sta�ng Structure built upon study demands and times procedures, customized for each protocol

Study Experience:Total: 310Phase 1b-2a Proof of MechanismProof of ConceptPhase 2bPhase 3

Site Highlight:New Acute Pain Capabilities:• Surgical Suite: 5 ORs/12 Beds• Sta� trained on analgesic

study methodology • 2 successful trials completed

in past 6 months in hernia and TKA surgical pain models

Facility Highlights

Midwest Clinical Research CenterDayton, Ohio

Midwest Clinical Research Center, a subsidiary of Evolution Research Group, is an inpatient and outpatient research facility experienced in psychiatry, neurology, addiction, sleep and pain indications. Located within a large medical campus, Midwest Clinical Research Center also conducts inpatient and outpatient post-surgical pain studies in association with an onsite surgical center.

• Founded in 2002 by Bernadette D’Souza, current Chief Scienti�c O�cer of ERG

• 19-bed clinical research unit with private and semi-private rooms

• Surgical suite with 5 operating rooms and 12 patient beds

• Sta� fully trained on analgesic trial methodology and placebo mitigation strategies

• Expertise on all pain scales and subject diaries

• Patient recreation/dining areas

• Team of neuropsychiatric raters certi�ed on multiple rating scales

• Dedicated, controlled and secure indoor smoking room

• Indoor smoking room equipped with a recirculating ventilation system

• Dedicated, controlled and secure outdoor smoking area

• Experience with topography, spirometry, CO measurements and PK biomarkers

• -20 and -70 degree freezers

• Refrigerated centrifuge

• Temperature-controlled, double-locked medication room with controlled key code and video monitored access

• Large source document room with controlled key code access

• Sta�ed 24/7 including emergency response team

• Procedural Sta�ng Structure built upon study demands and timed procedures, customized for each protocol

• Hospital located less than 2 miles from site

Study Experience:Total: 1,910First in HumanSAD/MADPK/PDBA/BEDDIFood E�ectFirst to FileCardiac Safety/TQT/QTc

Site Highlight:Coming Soon to CPMI: Onsite clinical/safety laboratory

services and expanded outpatient capabilities

Facility Highlights

Clinical PharmacologyOf MiamiMiami Lakes, Florida

Clinical Pharmacology of Miami (CPMI), a subsidiary of Evolution Research Group, has a 30 year history of providing its clients with unique capabilities, executing on complex trials in healthy volunteers and highly specialized populations. Several CRO clients trust CPMI's team to deliver when their own Phase I units are at capacity or a multi-center approach is needed.

• Newly renovated 24,000-square-foot, state-of-the-art inpatient and outpatient, custom-designed clinical pharmacology research unit

• 120 clinical research beds with six private rooms

• Two indoor recreational areas and secured outdoor patio

• Large screening area with interview and exam rooms, women's health exam room, and a pre-screening lab

• Large, secure PK processing lab with -20 and -70 degree sample storage and electronic monitoring and recording

• Double-locked, climate controlled pharmacy with laminar �ow hood, with sterile in-house compounding abilities, adhering to current

USP < 797 > and <795 > standards

• Validated environmental monitoring system for drug and sample storage

• Secured, monitored and alarmed unit with key-card and push-button access for designated sta�, 24-house CCTV recording

• 2 Standby 40-watt natural gas generators run at 100% if a power outage occurs

• Smoking room

• Negative pressure room

• Located within 30 minutes of two major international airports

• Close proximity to local imaging facilities

• Located in the heart of a vibrant, diverse community, providing access to 7 million individuals in the Greater Miami Area

• Experienced, long-term sta� includes bilingual medical graduates, registered nurses, technicians and phlebotomists

• Located 3.5 miles (about 5 minutes) from an emergency room

Study Experience:Total: 150Phase IbPhase IIProof of ConceptPhase IIISnowbird StudiesPK/PD

Site Highlight:Dr. Frederick Schaerf pioneered the “Snowbird” program for industry-sponsored trials. This allowed study subjects to remain in long term trials regardless of their seasonal transitions between states.

Facility Highlights

Neuropsychiatric Research Center of Southwest FloridaFort Myers, Florida

Neuropsychiatric Research Center of Southwest Florida, a subsidiary of Evolution Research Group, is an outpatient research facility conducting high quality clinical trials in Alzheimer’s Disease and other neurological disorders. The facility has a strong presence in the community with access to subjects through direct physician referrals.

• Founded by Frederick Schaerf, M.D., Ph.D., following his training at Johns Hopkins

• 3,300 square foot facility

• Strong presence in community, densely populated with adults 55 and older

• Unique Capabilities for “Snowbird Subjects” - NPRC has developed systems to assure the safety and welfare of subjects as well as the integrity of the study data at two locations allowing subjects to continue their study participation while wintering in Florida.

• Excellent reputation and established relationships conducive to physician referrals

• Collaborates with Imaging Centers for MRI/PET and others

• Dedicated private infusion areas including TV viewing and WiFi designed with subject comfort and safety as the priority

• Separate and private rating rooms

• Highly trained and experienced sta� with long tenure including neuropsychiatric raters certi�ed on multiple scales

• Secure double-locked camera monitored medication room

• On-Site CSF Sampling/O�-Site Continuous CSF Sampling

• CLIA Waived Laboratory On-Site

• Well-established initiatives/activities for recruitment including community outreach programs

Study Experience:Total: 150Phase 1/1bPhase 2/3 (Inpatient)Phase 2/3 (Outpatient)

Site Highlight:PRN has added capabilities to conduct Huntington’s Disease studies. With two HD advocates on sta� who also consult for several pharmaceutical clients, PRN is excited to be one of the only non academic research units in the US able to recruit and manage IP & OP clinical trials in this population.

Facility Highlights

Paci�c Research NetworkSan Diego, California and Rancho Bernardo, California

Paci�c Research Network, a subsidiary of Evolution Research Group, is an inpatient and outpatient research facility with two strategically located, fully operational sites. The facility in Downtown San Diego is the largest memory research center on the west coast with over 35 years of experience. The Rancho Bernardo facility is in a master-planned community located in the Northernmost part of San Diego.

• PRN has two locations in Southern California separated by 30 miles:

San Diego & Rancho Bernardo, CA

• San Diego Unit is a 6,000 square foot facility with 6 private inpatient rooms equipped with PSG

• Rancho Bernardo is a 2,100 square foot facility with 2 private inpatient rooms equipped with PSG

• Each facility has exam rooms, rating rooms, and monitoring areas equipped with WiFi

• Dedicated private infusion areas including TV viewing and WiFi designed with subject comfort and safety as the priority

• Controlled outdoor smoking space

• Secure, double-locked drug storage room with limited access

• -20 and -70 degree freezer for sample storage

• On-site lumbar puncture/CSF sample collection

• Large patient database of subjects

• Onsite memory assessments with genetic APoE testing

• Highly trained and experienced sta� with long tenure including neuropsychiatric raters certi�ed on multiple scales

• Well-established methods for recruitment including community outreach

Study Experience:Total: 180Phase IIa/IIbProof of ConceptProof of MechanismPhase IIIPK/PD

Site Highlight:BMR now has a second location, embedded within the Day Medical Treatment facility at The Kane Center in Stuart, FL. Founded by the Council on Aging of Marin County, Kane is the longest-serving senior services agency in the county and o�ers the most comprehensive resources for elders, their families and caregivers, with over 90 seniors visting the center per day.

Facility Highlights

Brain Matters ResearchDelray Beach, Florida

Brain Matters Research, a subsidiary of Evolution Research Group, is nationally recognized for its research into Alzheimer’s Disease and other memory disorders, such as Mild Cognitive Impairment and Age Associated Memory Impairment. Experience in other therapeutic areas includes Secondary Stroke Prevention, Migraine and Parkinson’s Disease.


• 6 private exam rooms

• 6 dedicated private infusion areas including TV viewing and WiFi designed with subject comfort and safety as the priority

• 2 onsite processing labs sta�ed with 2 full-time phlebotomists

• Secure onsite record storage as well as o� site long-term document storage with 24-hour retrieval availability

• Strong local presence built through community outreach to the substan-tial population of adults 55 years and older both healthy normal and those diagnosed with Alzheimer’s disease

• Recruitment catchment area includes Palm Beach and Martin Counties

• Collaborative relationships with community neurologists and primary care physicians to o�er research opportunities to patient population

• Work hand in hand with local care providers to ensure the highest level of medical oversight during clinical trial participation

• Onsite memory assessments with genetic APOE testing


• Facility is 1.5 miles away from �re house and paramedics

• 2 community hospitals are both within 3 miles of facility

Study Experience:Total: 200Phase 1 PilotsPhase 1b/2aProof of ConceptProof of MechanismPhase 3

Site Highlight:• Average of 127% enrollment

across inpatient and outpatient studies

• New 15 bed inpatient unit under construction to include on-site surgical suites

Facility Highlights

Endeavor Clinical TrialsSan Antonio, Texas

Endeavor Clinical Trials, a subsidiary of Evolution Research Group, has a 20 year history of providing its clients with services relating to post-surgical pain, chronic pain, podiatry and vaccine studies, executing complex trials on specialized patient populations, with an excellent track record of success.

• Over 20 years of experience conducting research with more than 200 completed clinical trials


• 6-bed IP unit specially designed for analgesic trials

• Sta� fully trained on analgesic trial methodology and placebo mitigation strategies

• Expertise on all pain scales and subject diaries



• Secured, limited access, temperature-controlled drug storage

• Flexible access to beds for postoperative pain studies requiring hospital-ization through long-standing collaborataions with Christus-Santa Rosa and Foundation Hospitals

• Locked, temperature-controlled record storage

• Dedicated screening area includes x-ray equipment

• Established multi-channel marketing process

• Network of physicians actively recruiting from their large private

practices

• Training: (CITI, IATA, and IVRS – multiple EDC Systems)

Evolution Research Group Portfolio Sites

Evolution Research GroupAffiliate Sites

Meet The Team

Brain Matters ResearchDelray Beach, FL

Clinical Pharmacology of MiamiMiami, FL

Endeavor Clinical TrialsSan Antonio, TX

Midwest Clinical Research CenterDayton, OH

NeuropsychiatricResearch CenterFort Myers, FL

Paci�c Research NetworkSan Diego, CA

St. Louis Clinical TrialsSt. Louis, MO

Thievon-Wright Consulting GroupWatchung, NJ

Woodland International Research GroupLittle Rock, AR

Woodland Research NorthwestRogers, AR

Advanced Memory Research Institute of New JerseyToms River, NJ

Alexian Brothers Neurosciences InstituteElk Grove Village, IL

CBH HealthGaithersburg, MD

Clinilabs NYCNew York, NY

Clinilabs NJEatontown, NJ

The Cognitive and Research Center of NJSpringfield, NJ

In Situ Global Clinical Trials NetworkGuaynabo, PR

NeurologyDiagnostics, Inc.Dayton, OH

NeuroTrialsResearch, Inc.Atlanta, GA

Paci�c Clinical Research Medical GroupUpland, CA

Research Centers of AmericaHollywood, FL

SPRI Clinical TrialsBrooklyn, NY

Meet The Team

Evolution Research Group Portfolio Sites

Evolution Research GroupAffiliate Sites

Brain Matters ResearchDelray Beach, FL

Clinical Pharmacology of MiamiMiami, FL

Endeavor Clinical TrialsSan Antonio, TX

Midwest Clinical Research CenterDayton, OH

NeuropsychiatricResearch CenterFort Myers, FL

Paci�c Research NetworkSan Diego, CA

St. Louis Clinical TrialsSt. Louis, MO

Thievon-Wright Consulting GroupWatchung, NJ

Woodland International Research GroupLittle Rock, AR

Woodland Research NorthwestRogers, AR

Advanced Memory Research Institute of New JerseyToms River, NJ

Alexian Brothers Neurosci-ences InstituteElk Grove Village, IL

CBH HealthGaithersburg, MD

Clinilabs NYCNew York, NY

Clinilabs NJEatontown, NJ

The Cognitive and Research Center of NJSpringfield, NJ

In Situ Global Clinical Trials NetworkGuaynabo, PR

NeurologyDiagnostics, Inc.Dayton, OH

NeuroTrialsResearch, Inc.Atlanta, GA

Paci�c Clinical Research Medical GroupUpland, CA

Research Centers of AmericaHollywood, FLSPRI Clinical TrialsBrooklyn, NY

Jim Aukstuolis, M.D., is board certi�ed in Adult and Child Psychiatry. Dr. Aukstuolis has served as Principal Investigator or Sub-Investigator on more than 100 trials for adult and pediatric/adolescent populations, including early and late stage studies in schizophrenia (stable and acute), bipolar disorder, depressive disorders, acute pain, among others. Dr. Aukstuolis also maintains a private practice where he treats child and adolescent psychiatric disorders.

George Konis, M.D., is board certi�ed in Family Medicine and Pain and Addiction. As Principal Investigator and Medical Director, he has participated in more than 150 clinical trials with challenging populations in psychiatric indications, cardiology, gastrointestinal disorders, pain, addiction, and general medicine. He is dedicated and committed to sponsors in the success of the execution and completion of all trials.

Ashley Poole, Site Director, holds a BS in Marketing and entered the clinical trial industry in 2005 as a regulatory coordinator at Woodland International Research Group. Ashley learned the business by serving in many operational roles prior to taking over site leadership in 2012. Under her direction, the site has opened a 16 bed clinical trial unit specially equipped to serve pediatric populations. Due to her passion and knowledge, Ashley is frequently engaged to serve on advisory boards by sponsors working on programs addressing chronic mental illness.

Woodland International Research Group

Subject and Patient Database:Patient Database 11,500ADHDAtopic DermatitisBipolar DisorderChronic PainDepressive Disorders Essential TremorMemory DisordersMigraineOpioid Use DisorderPostpartum DepressionPTSDTQT/ Cardiac SafetySchizophreniaSleep DisordersTobacco Product Users

Special Procedures and Equipment:CSF/cCSF Sampling PolysomnographyInfusionEEG/qEEGCrash Cart

O� Site Capabilities:MRI/fMRIPETX-RayUltrasoundsDaT ScanCT Scan

Sta�ng:Total Sta�: 52+

Fayz Hude�, M.D., is board certi�ed in Psychiatry and Neurology. He has participated in over 100 clinical trials in Schizophrenia, Alzheimer’s Disease, Bipolar Disorder, Depression and Addiction. Dr. Hude� joined Woodland Research Northwest 10 years ago and currently serves as Principal Investigator. In addition to his research, Dr. Hude� serves as Medical Director of the Geriatric Unit at Sparks Hospital.

Robert Billingsley Jr., M.D., joined Woodland Research Northwest in 2016 as Principal Investigator. Dr. Billingsley has served as a Diplomate for the American Board of Psychiatry and Neurology and has made contributions to more than 50 clinical trials in psychiatric disorders including depression, PTSD and schizophrenia.

Sarah Neubauer, PhD., joined Woodland Research Northwest in 2015 as the lead clinical rater and has since moved on to contributing as a Sub-Investigator. She has extensive academic and clinical research experience as well as publications in peer reviewed journals. Dr. Neubauer has participated in over 60 clinical trials over the past three years. In addition to research experience, she also has 8 years of clinical experience with a variety of populations including individuals with depression, schizophrenia, bipolar disorder and trauma.

Nichole Gutierrez, Site Director, holds a bachelors degree in sociology as well as being a licensed practical nurse. Nichole joined the WRN team in 2009 and since that time has been responsible for clinical and business operations. In 2016 under Nichole’s leadership, the site moved to a new facility to meet the site’s increased need for capacity as well as accomodate the separation of populations as the site moved into new indications. Recently, Nichole has been an active member of the STARR Coalition by serving on the STARR 911 committee which has been working in partnership with sponsors, sites, and patient advocacy groups to develop a tool kit for clinical sites to use when faced with subjects presenting with suicidal ideation.

Woodland Research Northwest

Subject and Patient Database:Patient Database 4,200ADHDAtopic DermatitisBipolar DisorderChronic PainDepressive Disorders Essential TremorMemory DisordersMigraineOpioid Use DisorderPostpartum DepressionPTSDTQT/ Cardiac SafetySchizophreniaSleep DisordersTobacco Product Users

Special Procedures and Equipment:CSF/cCSF SamplingPolysomnographyEEG/qEEGCrash Cart

O� Site Capabilities:MRI/fMRIPETX-RayUltrasoundDaT ScanCT Scan


Daniel Gruener, M.D., Chief Medical O�cer for Evolution Research Group, is board certi�ed by the American Academy of Psychiatry and Neurology and by the American Academy of Pain Management. He has over 30 years of Experience and has conducted more than 250 clinical trials in pain, addiction, psychiatry, and neurology disorders. Throughout his career, Dr. Gruener has been a thought leader in pain, and has served as a board member of the American Pain Society. Additionally, he has written several books, and most signi�cantly, he co-authored a textbook on pain and is the senior editor for Pain Control in the Primary Care Setting, published by the APS, which was the standard of care for several years.

Oksana Baram, M.D., is a board-eligible psychiatrist trained in both adult and pediatric psychiatry. Dr. Baram joined the team in 2017, has been training under Dr. Gruener and acting as a sub-investigator as well as a rater. Dr. Baram will be intimately involved in all of the pediatric trials as well as all adult studies.

Jacqueline Doan, Associate Director Clinical Operations, holds a bachelors in Organizational Management and has over 20 years of experience in clinical trial facility management and operations. Prior to joining SLCT in 2018, Jacqueline worked for a large CRO overseeing the expansion of multiple clinical trial units as well as serving in operational leadership positions. At SLCT, Jackie will be charged with maintaining the site’s high quality driving the organic growth initiatives.

Erica Ridol�, Senior Director, Clinical Operations and Site Development, is responsible for the operational oversight of all activities at St. Louis Clinical Trials. Erica joined the team in 2016 and has over 15 years of experience running a large 60 bed clinical research unit managing studies in all CNS indications, diabetes, various infectious diseases as well as healthy normal populations. Erica also supports the overall operations of ERG as well as the business development activities including protocol review and feedback, proposal development and client management.

St. Louis Clinical Trials

Subject and Patient Database:Patient Database 62,200Alzheimer’s DiseaseADHDBipolar DisorderCognitive DisordersDepressive DisordersDiabetes - Type 2Essential TremorHepatitis Memory DisordersMovement DisordersOpioid Use DisorderPain (Acute/Chronic)PTSDRecreational Drug UsersSchizophreniaSleep DisordersTobacco

Special Procedures and Equipment:CSF/cCSF SamplingPolysomnographyEEG/qEEGCrash Cart

O� Site Capabilities:MRI/fMRIPET/fdgPETX-RayUltrasoundDaT ScanCT Scan

Sta�ng:Total Sta�:40+

Otto Dueno, M.D., is the Medical Director of Midwest Clinical Research Center. He has served as Principal Investigator or Sub-Investigator on 82 clinical trials. He also maintains an outpatient clinical practice and has extensive experience in acute adult inpatient care and geriatrics. Dr. Dueno is a member of the Ad Hoc Advisory Committee on Addiction and Pain Control Issues for the Ohio Psychiatric Physicians Association. He received his medical degree from Univerdad Central del Caribe School of Medicine in Puerto Rico and completed his residency in Psychiatry at The Ohio State University. He is board certified by the ABPN.

Gerald Cephas, M.D., is a general surgeon who has been working in CNS research for 10 years. He has served as Sub-Investigator and Rater on over 80 clinical trials. He became licensed in Ohio in 2017 and will begin assuming the role of Principal Investigator working alongside Dr. Dueno. He received his medical degree from University of Virginia, School of Medicine, Charlottesville, VA and completed his residency in general surgery at University of Virginia Health System in 2001.

Dr. Isabel Kuhar-Arcure, D.O., is a pediatrician who joined Midwest Clinical Research Center in 2015. Dr. Kuhar-Arcure has served as Principal Investigator and Sub-Investigator on more than 25 clinical trials. She received her medical degree from University of Medicine and Dentistry of New Jersey in Stratford, New Jersey, and completed her residency at Robert Wood Johnson Hospital, New Brunswick, New Jersey.

Melissa Ellis, Site Director, has more than 14 years of clinical trial experience managing both clinical and business operations. Since joining the MCRC team in 2015, Melissa has continued the site’s success in psychiatric trials while also driving the site’s organic growth into new indications. Melissa has been integral in setting up post operative capabilities in both bony and soft issue models as well as FDA mandated tobacco trials.

Midwest Clinical Research Center

Subject and Patient Database:Total 29,800AddictionADHD DisordersBipolar DisorderDepressionEating DisordersEssential TremorsFibromyalgiaAnxiety DisordersMigraineOpioid Use DisorderPain Chronic and AcutePostpartum DepressionPTSDSchizophreniaSleep DisordersTobacco UseTardive Dyskinesia

Special Procedures and Equipment:CSF/cCSF SamplingPolysomnographySmoking RoomEEG/qEEGCrash Cart



Kenneth C. Lasseter, M.D., is the Vice President and Medical Director of CPMI. Dr. Lasseter is a clinical pharmacologist certi�ed by the American Board of Clinical Pharmacology and is board eligible in Cardiology and Internal Medicine. Over the past 40 years, he has served as Principal Investigator on over 1,800 clinical trials.

Samuel Oberstein, M.D., is the Assistant Medical Director/ Investigator at Clinical Pharmacology of Miami. Dr. Oberstein has worked in clinical research for over 20 years and has served as the Principal Investigator on over 130 clinical trials. He is board certi�ed in Obstetrics and Gynecology.

Antoinette M. Sulpizi, M.D., is one of the Investigators at Clinical Pharmacology of Miami. Dr. Sulpizi is board certi�ed in Internal Medicine and Cardiology in Pennsylvania and Florida. Dr. Sulpizi has contributed to over 30 studies throughout her career in research.

E. Cooper Shamblen is the Vice President of Clinical Operations. In 1977, he and Dr. Kenneth C. Lasseter founded Clinical Pharmacology Associates. With 36-plus years of experience in partnership with Dr. Lasseter, he has been involved in all aspects required to successfully perform over 1,800 clinical research studies. His reputation and experience in the pharmaceutical industry will make your choice to engage the services of CPMI a pleasure, as well as a success.

Stacy C. Dilzer, R.N., B.S.N., serves as President of Clinical Pharmacology of Miami. During the past 25 years, her positions have included Study Coordinator, Project Manager, Director of Clinical Operations, Chief Compliance O�cer and Vice President of Clinical Operations. Her experience and expertise include the overall management and supervision of all Phase I-IV clinical trials. Ms. Dilzer leads and manages all aspects of the day-to-day operations of Clinical Pharmacology of Miami. Stacy is frequently sought out by sponsors as an operational leader in early phase execution to advise them on study design for healthy volunteer trials as well as studies involving patients with renal insu�ciency and hepatic impairment. Her drive for excellence is evidenced in recent history as she led the site through 4 FDA inspections between 2016 and 2018 with no signi�cant �ndings.

Clinical PharmacologyOf Miami

Subject and Patient Database:Total 9,800DiabetesHealthy Volunteers Adult and ElderlyHepatic ImpairedHypertensionKidney DiseasesLiver Diseases Low TestosteroneNASHObesityRenal Insu�ciencyPost-MenopausalSexual DysfunctionTobacco Product Users

Special Procedures and Equipment:NegativePressure Room Crash CartHolter Monitoring/TelemetryPulse OximetryPulmonary Function TestingUltrasoundPapsmear

O� Site Capabilities:Liver BiopsyMRI/fMRIDigital PET/CTX-rayEEG/qEEG


Frederick Schaerf, M.D., Ph.D., is board certi�ed by the American Board of Psychiatric and Neurology in Adult and Forensic Psychiatry. Dr. Schaerf specialized in Neuropsychiatry at Johns Hopkins and was instrumental in starting the psychiatric AIDS services at Johns Hopkins Hospital. In 1999, Dr. Schaerf was one of 39 Psychiatrists in the United States to receive the Exemplary Psychiatrist Award from the National Alliance of the Mentally Ill. Dr. Schaerf founded Neuropsychiatric Research Center in 2001.

Wendy Bond, M.D., joined Dr. Schaerf at Neuropsychiatric Research Center, trained under him, and now serves as Principal Investigator on multiple trials. She is board certi�ed by the American Board of Psychiatry and Neurology. For the past 13 years, Dr. Bond has practiced General Neurology in the Fort Myers and Cape Coral area. Dr. Bond was also the previous medical director of the Lee Health ALS Clinic.

Melissa Schaerf, M.S., A.R.N.P., Sub-Investigator/Site Director, has been managing the operations of NPRC since the beginning and is also a highly experienced rater. She is an operational expert and is frequently consulted by sponsors and CROs on the design and execution planning for clinical trials in Alzheimer’s patients. She also is intimately involved with outreach programs and training across ERG’s portfolio sites.

Neuropsychiatric Research Center of Southwest Florida

Subject and Patient Database:Healthy ElderlyAlzheimer’s DiseaseDementiaMild Cognitive ImpairmentALSMovement Disorders Parkinson’s Disease

Special Procedures and Equipment:APOE Genetic TestingCSF SamplingInfusionsCrash CartAEDMemory Assessments

O� Site Capabilities:cCSF SamplingMRI and PET Ophthalmic ExamsCompounding Pharmacy


Stephen G. Thein, Ph.D., the Director and Founder of Pacific Research Network, has conducted over 380 trials in the past 40 years and is one of the nation’s leading researchers in the field of memory and Alzheimer’s Disease. Dr. Thein has participated in the testing of new medications to treat Alzheimer’s Disease, Memory Loss, Anxiety, Migraine, Sleep Disorders, Sexual Dysfunction, Social Anxiety, Multiple Sclerosis and Weight Loss. Recognized as a leading researcher and lecturer in CNS/Neurology.

Thomas J. Reilly, M.D., is board certified in Occupational and Environmental Medicine and serves as a Principal Investigator and Sub- Investigator on several clinical trials. He received his medical degree from Georgetown University and a Master’s in Public Health from San Diego State University.

Daniel Lawler, M.D., is board certified in Anesthesiology and has a certificate from the Clinical Trials Research and Design Program, University of California San Diego, San Diego, Calif. Dr. Lawler continues to serve as Chair for the Department of Anesthesia, Colorado Plastic Surgery Center, Coronado, Calif., and Sta� Anesthesia at the San Diego Out-Patient Surgery Center, San Diego, Calif. He has worked on numerous CNS trials, predominantly infusion-related AD and MS studies requiring single or repeated lumbar punctures.

Arthur M. Flippin, M.D., is a board-certified neurologist with over 20 years of practice in general neurology, caring for patients with a wide range of neurological conditions. He serves as Principal Investigator and Sub- Investigator with Pacific Research Network on CNS trials.

Dixie Creager, Site Director, has been managing the clinical and business operations of Paci�c Research Network for over 25 years. She identi�ed the opportunity for expansion in Rancho Bernardo and lead the build-out activities. Dixie is frequently engaged by pharmaceutical companies developing treatments for memory and sleep disorders to provide protocol and study design input from an operational perspective to ensure the smooth initiation and execution of early and late phase clinical trials.

Paci�c Research Network

Subject and Patient Database:Total: 24,000Age Associated Memory ImpairmentAlzheimer’s DiseaseAnxietyDementiaDepressionEssential TremorsHealthy ElderyHuntington’s DiseaseMigraineMild Cognitive ImpairmentMultiple SclerosisParkinson’s DiseaseSleep Disorders

Special Procedures and Equipment:APOE Genetic TestingCSF/cCSF SamplingInfusionsCrash CartAEDMemory Assessments


Sta�ng:Total Sta� (San Diego): 20+Total Sta� (Rancho Bernardo): 8+

Mark Brody, M.D., CPI., is the Director and Founder of Brain Matters Research. Dr. Brody is certi�ed by the Academy of Clinical Research Professionals as a Certi�ed Physician Investigator. He is a former Professor of Neurology at the University of California, San Diego and Stroke Program Director at Scripps, La Jolla. Dr. Brody relocated to Palm Beach County in 1995 where is continues to conduct clinical research in more than 180 trials – specializing in Alzheimer’s Disease, MCI, Dementia and Stroke.

Paayal Patel, M.D., is a neurologist specializing in cognitive disorders including dementia and neuropsychiatry. Prior to joining Brain Matters Research, Dr. Patel completed her fellowship in cognitive behavioral neurology at the Cognitive Neurology & Alzheimer’s Disease Center at the Northwestern University Feinberg School of Medicine in Chicago, IL.

Ana Fuquay, Site Director, hold a MS in Mental Health Counseling and joined the Brain Matters team in 2006 as a Psychometrician and Clinical Research Coordinator. In 2012, she stepped into a leadership role managing the clinical and business operations at the site. Ana is currently leading the site’s expansion of a satellite facility in Stuart, Florida at the Kane Center which touches more than 3,500 lives of those 55 and older.

Brain Matters Research

Subject and Patient Database:Age Associated Memory ImpairmentAlzheimer’s DiseaseMild Cognitive ImpairmentSecondary Stroke PreventionParkinson’s DiseaseMigrainePHNDPN

Special Procedures and Equipment:APOE Genetic TestingCSF/cCSF SamplingInfusionsCrash CartAEDMemory Assessments



Richard Pollak, D.P.M., M.S., is a Key Opinion Leader and board certi�ed by the American Board of Foot and Ankle Surgery. He has been practicing for over 35 years in San Antonio, Texas and has been the Principal Investigator in more than 125 studies. He is an expert in multiple areas of podiatry including toenail fungus, athlete’s foot and diabetic foot ulcers. Dr. Pollak has authored and published many scienti�c articles and he is a noted national lecturer.

Constance Barone, M.D., is board certi�ed by the American Board of Plastic Surgery. She has been recognized as one of America’s Top Surgeons for 2016 by the Consumers’ Research Council of America.

Russell Stanley, D.P.M., is a Doctor of Podiatric Medicine and has participated in over 25 clinical trials as an Investigator at Endeavor Clinical Trials.

Lisa Rodriquez, Site Director, has more than 20 years of clinical trial experience and is responsible for managing both the clinical and busines operations at Endeavor Clinical Trials. Under Lisa’s leadership, ECT expanded their capabilities to include an independently operated clinical trial unit allowing the housing pf post operative pain subjects after surgical procedure to ensure the highest quality of data collection. Lisa’s drive for excellence in quality was exempli�ed in the site’s most recent FDA inspection in March 2018 where there were no signi�cant �ndings.

Endeavor Clinical Trials

Subject and Patient Database:Post-Surgical Pain • Bunionectomy • Abdominoplasty • TKA/THA • Hernia Repair • Third Molar Extraction • Bariatric Surgery • MammoplastyOutpatient: • DFU/DFI • DPN/PHN • Type 2 Diabetes Mellitus • Gout • Onychomycosis • Osteoarthritis • Plantar Fasciitis • Tinea Pedis • Vaccine

Special Procedures and Equipment:Pulse OximetryDiagnostic UltrasoundNerve Conduction MonitorSudoscanCrash CartX-ray

O� Site Capabilities:MRI/fMRIPETUltrasoundDaT ScanCT Scan


Documents

Woodland International Clinical Pharmacology ... › ... › 05 › Midwest-Clinical-Research...in past 6 months in hernia and TKA surgical pain models ... Midwest Clinical Research