Therapeutic Areas

Dental and Oral Health
Internal Medicine
Neurology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Sleep

Center Overview

Clinical Trial Developers is a dedicated site management organization. We aid private practice physicians in the development of a clinical trial programs at their site. With eight years of experience in the research arena and over 25 years in health care, we are able to offer a variety of services to your site including:

Study Coordinator Identification:

• Qualifications
• Selection
• Education
• Payment and hours required

Principal Investigator Role:

• Responsibilities
• Education
• Payment and hours required

Institutional Review Board (IRB) Function in Clinical Trials:

• Types of IRB’s
• IRB Responsibilities
• Vulnerable Subjects
• State and Local Regulations
• Investigator Reporting
• Continuing Review

Informed Consent Delivery:

• Defining Informed Consent
• Obtaining Informed Consent
• The Consent Process
• Assenting Process

Regulations and Good Clinical Practices (GCP):

• FDA Regulations
• ICH Guidelines for GCP
• FDA Compliance
• HIPAA
• Recruiting and Retention of Subjects
• Obtaining ICF

Overview of the Research Process:

• Pre-Clinical Research
• Clinical Trial Phases
• Studies Involving Children

Standard Operating Procedure (SOP) Development:

• Writing SOP’s
• Approval, Training, and Implementation
• SOP’s for Investigational Sites

Protocols and Case Report Forms (CRF’s):

• Protocols: How to read/To select the best trial for your site
• Case Report Forms
• Electronic Data Capture
• Evaluable Data
• Quality Assurance (QA)

Preparing for a Study:

• Site Assessments
• Protocol Feasibility
• Grants, Budgets, Contracts
• Investigative Site Study Files
• Storage of study materials
• Study Documents
• Financial Disclosure
• Investigator Meetings
• Working with CRA’s
• Sponsor Interaction
• Shipping Samples

Working with Study Subjects:

• Recruitment
• Advertising
• Information for Potential Subjects
• Compensation for Subjects
• Incentive Payments to Healthcare Professionals
• Scheduling
• Retention
• Compliance

Study Closure:

• Closeout Procedures
• Investigator final report to sponsors and IRB
• Administration Issues
• Record Retention

Adverse Events (AE) and Safety Monitoring:

• Regulations
• Definitions
• AE of Marketed Products
• AE in Clinical Trials
• Investigator Reporting Responsibilities
• Sponsor Responsibilities
• Difference between Clinical Trial and Clinical Practice
• Assessing Relationship of AE to Study Drug

Audits:

• Sponsor Audits
• IRB Audits
• FDA Audits
• Consequences
• Quality Assurance Reviews

Resources:

• Clinical Trial Developers, Inc.
• Sponsor
• IRB
• FDA website
• Clinical Research Associates (CRA)

Ongoing Support:

• Contract and Budget negotiations
• Regulatory Submission
• Recruitment Strategies
• Subject Retention
• Protocol Development and Submission

The Mission of Clinical Trial Developers, Inc. (CTD) is to establish a profitable research environment in privately owned physician's practices, creating top line growth opportunities, and early access to emerging treatments and cutting-edge medical technologies. Our unique services include providing long term training and support, site marketing and development, budget and contract negotiations, as well as regulatory document preparation and submission.

Clinical Research Experience

Oral and Maxillofacial Surgery

Michael B. Lee, D.D.S.
Site Contact: Laura Lytle
Statewood Professional Park
7523 State Road
Cincinnati, Ohio 45255
Office: (513)232-8989
laura@cincinnati-oralsurgery.com
www.cincinnatijawsurgery.com
sandytagher@yahoo.com

Dr. Lee’s Oral and Maxillofacial Surgery service specialties include:

• Extractions
• Wisdom Teeth
• Implants
• Fractures
• Bone Grafts
• Orthognathic Surgery
• TMJ (anxiety related to TMJ)
• Post operative care
• Dental Care

Dynamic Mental Health Services, LLC
Site Contact: Richard P. Yarbrough, LPCC
999 Lila Avenue
Milford, Ohio 45150
Office: (513)831-0770
dynamicmentalhealthservices@gmail.com

Bernard DeSilva, MD Psychiatry

Psychiatric services for Children:
Counseling and specialized care are provided by licensed therapists. Confidential counseling helps children and families with problems resulting from mental illness, abuse, family conflict, divorce, Attention Deficit Disorder (ADD) and school and behavioral issues. Services include assessment, treatment planning, counseling, case management, and, if necessary, psychiatric support services.

Psychiatric services for Adults:
Services include counseling services and psychotherapy for individuals. Outpatient behavioral health treatment is available for adults with:

• Mental health issues
• Co-occurring substance abuse disorders
• Anxiety, depression, or experience an episode of psychiatric illness
• Chronic mental illness
• Deaf & Hard of Hearing

Specialized mental health care is available for seniors. Services are designed to help clients use their personal strengths to deal with a broad range of personal, relational or work problems. Consultation, Assessment, Medication/Somatic, and Education are available

Neurology Diagnostics Inc.

Site Contact: Grace Smither
One Elizabeth Place
First Floor: Suite B
Dayton, Ohio 45417
Phone: (937) 224-8200
Fax: (937) 224-1770
gsmither@ndidayton.com

This is an outpatient setting providing EMG services as well as all General Neurology services.

CLINIAL TRIAL EXPERIENCE

Joel Vandersluis, M.D., F.R.C.P.C.

"Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction Study" sponsored by National Institutes of Neurological Disorders and Stroke (NIH), 2003

"Carbatrol SPEQT Trial (Safety, Preference, Effectiveness, QoL, Tolerability)"

"A Double-Blind, Placebo-Controlled Parallel Group, Dose Response Study to Evaluate the Efficacy and Safety of Compound versus Placebo in the Treatment of Pain Associated with Diabetic Peripheral Polyneuropathy." 1999-2000.

"A Randomized, Double-Blind. Parallel-Group, Monotherapy Study to Compare the Safety and Efficacy of Two Doses of Compound in the Treatment of Newly Diagnoses or Recurrent Epilepsy." 1999-2000.

"Pilot MRI Study of Compound in Ambulatory Subjects with Relapsing Multiple Sclerosis." 2000-2001.

Co-Investigator: Evaluation of the Efficacy and Tolerability of UCB L059 (Levetiracetam) Add-on Treatment in Epileptic patients with Partial Onset Seizures: A Thirty Eight (38) week Double-Blind Placebo-Controlled Parallel Group Multicenter Trial.

Co-Investigator: Migramist in the Treatment of Acute Migraine Headache: A Double-Blind, Randomized, Placebo-Controlled Study to Determine The Effectiveness and Safety of Migramist (Dihydroergotamine Mesylate Nasal Spray) 2 mg for the Acute Treatment of Migraine Headache with or without Aura in Migraineur Families. (Sandox DHE-454).

Co-Investigator: A Randomized Double-Blind Multi Investigator Study of Once Daily Uniphyl 400 mg Tablets and Proventil Repetabs Twice Daily in Nocturnal Asthma (Purdue Frederick UN91-501).

Developed and Instituted Protocols for the use of Tissue Plasminogen Activator in Acute Stroke Management, Miami Valley and Good Samaritan Hospitals, 1997.

Principal Investigator: 2012, A 12 Month,Prospective, Randomized, Active-controlled, Open-labeled studyto evaluate patient retention of two first line disease modifying therapies in adults who are in early stages of treatment for relapsing remitting multiple sclerosis.

Family Practice Center of Wooster
Site Contact: Kim Byrne, RN
128 E. Milltown Rd. Suite 205
Wooster, Ohio 44691
Phone: (330) 345-2008
Fax: (330) 345-0056
biovailrep@yahoo.com
www.fpcwooster.com

Raymond G. Mason, M.D.

CLINICAL TRIAL EXPERIENCE

Influenza
Hypertension

2012 Principal Investigator: Phase II - A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study in Adult Subjects with Partly Controlled and Uncontrolled Asthma

2012 Principal Investigator: Safety and Efficacy Evaluation of an Otic Suspension in the Treatment of Acute Otitis Externa

2012 Principal Investigator: Cross-sectional, Observational Study to Evaluate COPD Severity Using Spirometry and Physician and Patient Assessment

Services Include:
General Family Practice Care with Asthma, Diabetes, Hypertension, Well Child Care, Care for the family with infants, toddlers, adolescents, and Adults

Robert V. Sibilia, M.D., Inc.

Site Contact: Beth Rigney BSN, CCRC
324 E. Milltown Rd. Suite A
Wooster, Ohio 44691
Phone: (513) 293-2449
Fax: (513) 575-0862
brigney@clinicaltrialdevelopers.com

CLINICAL TRIAL EXPERIENCE

Monomer chemistry research on absorbable suture material and oral Itraconazole. Ethicon Corporation, Summerville, N.J. (1986)

Facility Description

Cincinnati Jaw Surgery

Michael Lee provides a variety of orthodontic outpatient surgery services on site. He is located directly across from Anderson Mercy Hospital in Cincinnati, Ohio. This location provides easy access from Interstate I-275, off 5 Mile Road. Dr. Lee is one of few oral surgeons who offer orthognathic surgery.

Principal Investigator: Michael B. Lee, DDS
Statewood Professional Park
7523 State Road
Cincinnati, Ohio 45255
www.cincinnatijawsurgery.com

Dynamic Mental Health Services, LLC
Dynamic Mental Health Services, LLC is located near the Milford Parkway exit off of Interstate I-275 in Cincinnati, Ohio. Dynamic is an outpatient setting that offers a wide variety of mental health consultation and therapy.

Principal Investigator: Bernard De Silva, MD
Coordinator: Richard P. Yarbrough
999 Lila Avenue
Milford, Ohio 45150
Office: (513) 831-0770
Fax: (513) 831-0770
dynamicmentalhealthservices@gmail.com

Neurology Diagnostics, Inc
Neurology Diagnostics, Inc. is located in Dayton, Ohio near interstate 75 in the West Medical Pavilion at One Elizabeth Place, 1st floor Suite B. This is an outpatient setting providing EMG services as well as all General Neurology services.

Principal Investigator: Joel Vandersluis, M.D., F.R.C.P.C.
Coordinator: Grace Smither
1 Elizabeth Place
West Medical Pavilian
1st Floor, Suite B
Dayton, Ohio 45408
Office: (937) 224-1770
gsmither@ndidayton.com

Family Practice Center of Wooster

Family Practice Center of Woosteris an outpatient setting providing a wide variety of healthcare opportunities for ages birth to and including adults.Ourconvenient location is near Ohio Route 3 on Milltown Rd, past the Cleveland Clinic’s satellite office building.

Principal Investigator: Raymond G. Mason, M.D.
Site Contact: Kim Byrne, RN
128 E. Milltown Rd. Suite 205
Wooster, Ohio 44691
Phone: (330) 345-2008
Fax: (330) 345-0056
biovailrep@yahoo.com
www.fpcwooster.com

Robert V. Sibilia, M.D., Inc.

Dr. Robert Sibiliahas developed a thriving practice supplying pulmonary care for a wide range of therapeutic areas, as well as a fully equipped sleep study practice with three suites for all phases of trial. The convenient location just off route 3, and less than 3 miles from the local hospital and emergency room.

Principal Investigator: Robert V. Sibilia, M.D.

Site Contact: Beth Rigney BSN, CCRC
324 E. Milltown Rd. Suite A
Wooster, Ohio 44691
Phone: (513) 293-2449
Fax: (513) 575-0862
brigney@clinicaltrialdevelopers.com

Investigator Experience

Dr. Michael B. Lee, DDS
Maxillofacial and Oral Surgery

CURRICULUM VITAE

Michael B. Lee, DDS
7523 State Road
Cincinnati, Ohio 45255
(513) 232-8989

Education:

• 1969-1974 University School of Pharmacy and Pharmaceutical Sciences
• 1974-1978 DDS – Indiana University School of Dentistry
• 1978-1979 Internship, University of Cincinnati Medical School, Department of Surgery, Division of Oral and Maxillofacial Surgery
• 1979-1980 Senior Resident, University of Cincinnati Medical Center, Department of Surgery, Division of Oral and Maxillofacial Surgery
• 1980-1981 Chief Resident, University of Cincinnati Medical Center, Department of Surgery, Division of Oral and Maxillofacial Surgery

Licensure:

• 1974 R.Ph. State of Indiana
• 1978 DDS State of Indiana
• 1978 DDS State of Ohio

Certificate:

• 1977 National Board of Dental Examiners
• 1978 Northeast Regional Board of Dental Examiners
• 1987 American Board of Oral and Maxillofacial Surgery

Academic Appointments:

• 1990-Present Volunteer Assistant Professor University of Cincinnati Medical Center, Department of Surgery, Division of Oral and Maxillofacial Surgery

Hospital Appointments:

• 1981-Present
  University of Cincinnati Medical Center
  Department of Surgery
  Division of Oral and Maxillofacial Surgery
  231 Goodman Avenue
  Cincinnati, Ohio 45267
• 1983-Present Mercy Hospital Anderson
  Active Staff
  7500 State Road
  Cincinnati, Ohio 45255

Committee Appointments:

• 1991-2001 Mercy Hospital Anderson Surgical Supervisory Committee Liaison
  Director of Oral and Maxillofacial Surgery
• 1992-1995 Pharmacy and Therapeutics Committee Mercy Hospital Anderson
• 1992-Present Dental Care Plus Quality Assurance Committee
• 1998-2001 Vice President of Mercy Anderson Ambulatory Surgery Center
• 2010-Present Strategic Planning Reorganization Task Force Children’s Dental Care Foundation
• 2010-Present Cincinnati Dental Society Peer Review Board

Professional Memberships:

• American Dental Association
• American Association of Oral and Maxillofacial Surgeons
• Ohio Dental Association
• Cincinnati Dental Society
• Cincinnati Society of Oral and Maxillofacial Surgeons
• American Association of Dental Consultants
• American Dental Society of Anesthesia

Publications:

• Lee, Michael B., Grau, William H.,: Drug Induced Xerostomia, Pharmacy Times
  Vol. 45:36 July 1979
• Lee, Michael B., : Successful Premedication of the Dental Patient, American Pharmacy, NS21:31 September, 1981
• Lee, Michael B., : Do Pharmacists Practice Dentistry, American Pharmacy, NS23#4:30 April, 1983
• Lee, Michael B., : Oral Ulcerations, Update and Current Treatment, Pharmacy Times, Vol. 52:58
• Lee, Michael B., : Crocker, Daniel J., Gaines, Roy E., Osteochrondroma of the Mandibular Condyle: Case Report and Review of Literature, Journal of Oral and Maxillofacial Surgery, Vol. 50 No. 8:899 August, 1992

Presentations:

• 2000
  • "Treatment Options for Condylar Fractures," University of Cincinnati Medical Center, Division of Oral and Maxillofacial Surgery, Grand Rounds (January, 2000)
  • "Surgical Management of Mid-facial Transverse Skeletal Deformities," University of Cincinnati Medical Center, Division of Oral and Maxillofacial Surgery, Grand Rounds (February 2000)
  • "CT Dentascans for Dental Implant Reconstruction and Diagnosing Dental Enigmas," Southwest Ohio Valley Dental Society (February 2000)
  • "CT Dentascan: Uses in Implant Dentistry and a New Tool for Diagnosing Dental Enigmas," Cincinnati Dental Society (October 2000)
  • "Orthognathic Surgery and Facial Aesthetics," University of Cincinnati Medical Center, Department of Otolaryngology Facial Plastic Lecture Series (November 2000)
• 2001
  • "Dentascan: Uses in Implant Dentistry and a New Tool for Diagnosing Dental Enigmas," Cincinnati Eastside Dental Study Club (January 2001)
  • "Evaluation and Treatment Planning of Mandibular Fractures," University of Cincinnati Medical Center, Department of Plastic and Reconstructive Surgery
  • "Examination, Evaluation and Treatment Planning of Condylar Fractures," University of Cincinnati Medical Center, Department of Otolaryngology Facial Plastic Lecture Series (December 2001)
• 2002
  • "Orthognathic Surgery and Facial Aesthetics," University of Cincinnati Medical Center, Department of Otolaryngology Facial Plastic Lecture Series (October 2002)
• 2004
  • “CT Dentascan/Bone Template Fabrication for Dental Implant Reconstruction,” Cincinnati Dental Society (March 2004)
• 2005
  • "Dentascan: Uses in Implant Dentistry and a New Tool for Diagnosing Dental Enigmas," Cincinnati Eastside Dental Study Club
• 2006
  • "Dental Implant Treatment Planning Using Computer Generated Surgical Templates and 3-Dimensional Bone Scanning," Cincinnati Dental Society (March 2006)
• 2007
  • "Three-Dimensional Dental Imaging and Oral Surgery," Greater Cincinnati Dental Study Club (February 2007)
• 2009
  • "Obstructive Sleep Apnea and 3-D Imaging," Spring 2009 Greater Cincinnati East Side Dental Study Club
• 2010
  • "Keys to Successful Treatment of Obstructive Sleep Apnea," Cincinnati Dental Society (February 2010)

CURRICULUM VITAE

Bernard DeSilva, M.D.
999 Lila Avenue
Milford, OH 45150
(513) 831-0770

• 1965 Graduate, Ceylon Medical College, University of Ceylon (Sri Lanka)
  Medicine, General Surgery, OB-GYN, Pediatrics andEmergency Medicine
• 1966 Kings College, Dulwich Hospital, Senior House Surgeon
• 1967 Plymouth General Hospital, Devonshire, United Kingdom, Senior House Surgeon
• 1968-1969 Emergency Medical Services, London
  Royal London Homeopathic Hospital, London, United Kingdom, Senior House Surgeon
  St. Peter’s Hospital, Chertsey Surrey, England – Orthopedics - Emergency Rowley Bristow Orthopedics Hospital, Surry, United Kingdom, Senior House Surgeon – Orthopedics – Accident and Trauma Emergencies
• 1969-1972 Rollman’s Psychiatric Institute, Cincinnati, OH
  Resident Physician – 3 yr. Psychiatric Residency Program
• Probate Court, Cincinnati, OH, Expert Witness in Hamilton, Clermont, Brown and Highland Counties
• 1969-1998 Private Practice in Psychiatry - Cincinnati, OH
• 1969- Present Private Practice in Psychiatry - Milford, OH
• 1972-1986 Established and directed Mental Health Center in Georgetown, OH, serving Clermont, Brown, Clinton and Highland counties.
• 1994-1998 Ohio Reformatory for Women in Marysville, OH – Psychiatrist Allen Correctional Institute, Lima, OH – Psychiatrist
  Lebanon and Warren Correctional Institutes

AFFILIATIONS

• American Board of Psychiatry and Neurology, Board Eligible
• Fellow, Royal College of Surgeons, United Kingdom
• Diplomatic Board of Forensic Psychiatry
• Member of Board of Forensic Examiners

CURRICULUM VITAE

JOEL VANDERSLUIS, M.D.

EDUCATION

• 1994-95 Fellowship
• Electromyography, Case Western Reserve University

Department of Neurology, Cleveland, Ohio
Director: Dr. B.Katirji

• 1994-95 Fellowship

Headache & Pain Management, Case Western Reserve
University, Department of Neurology, Cleveland, Ohio
Director: Dr. T. Chelimsky

• 1991-94 Residency

Case Western Reserve University, Department of Neurology,
Cleveland, Ohio
Program Director: Dr. R.B. Daroff

• 1990-91 Internship

McMaster University, Department of Internal Medicine,
Hamilton, Ontario Canada
Program Director: Dr. G. Guyatt

• 1986-89 Medical

McMaster University, Faculty of Health School Sciences,
Hamilton, Ontario Canada

• 1980-84 College

University of Toronto, Faculty of Applied Science &
Engineering, Toronto, Ontario Canada

PROFESSIONAL ASSOCIATIONS/LICENSES & DIPLOMAS

• 2002

Co-Chair, American Heart Association “Operation Stroke”,
Montgomery County, Ohio

• 2002

Certification, Physician Leadership Lecture Series, Premier
Health Partners, Dayton, Ohio

• 1997

Board Certified, American Board of Electrodiagnostic Medicine

• 1995

Board Certified, American Board of Psychiatry and Neurology

• 1994

Board Certified, Royal College Physicians & Surgeons of Canada, Neurology

• 1992-Present

American Academy of Neurology - Member

• 1990-Present

College of Physicians and Surgeons of Ontario

PRACTICE

• 2002-Present

Neurology Diagnostics, Inc., Owner, General Practice of Neurology, Dayton, Ohio

• 1999-2001

Neurology Center of Southwestern Ohio, Partner, General practice of Neurology, Dayton, Ohio

• 1995-1999

NeuroCare Inc., Partner, General practice of Neurology, Dayton, Ohio

• 1993-1995

Bedford Community Hospital, Bedford, Ohio, Department of Emergency Medicine

• 1990-1991

McMaster University Hospitals and Hamilton Civic Hospitals, Hamilton, Ontario, Department of Internal Medicine, Division of Critical Care

MEDICAL AND ACADEMIC APPOINTMENTS

• 2010-Present

Kettering Medical Center, Dayton, Ohio – Medical Staff

• 1998-Present

Clinical Associate Professor of Neurology, Wright State University School of Medicine, Dayton, Ohio

• 1995-Present
Miami Valley Hospital, Dayton, Ohio – Medical Staff

• 1995-Present

Good Samaritan Hospital, Dayton, Ohio – Medical Staff

• 1994-1995

Mount Sinai Hospital, Cleveland, Ohio – Department of Neurology Associate Staff

• 1993-1995

University Hospital, Division of Clinical Research, Department of Neurology. Case Western Reserve University, Cleveland, Ohio, Associate

• 1991-1995

University Hospital, Department of Neurology, Case Western Reserve University, Cleveland, Ohio, Resident and Fellow

• 1993-1994

University Hospital, Quality Assurance Committee, Case Western Reserve University, Cleveland Ohio

• 1991-1994

Wade Park Veteran’s Hospital, Department of Neurology, Cleveland Ohio, Resident

PUBLICATIONS AND PRESENTATIONS

Vandersluis, J: Asterixis, Calorics, Craniocervical Junction, ECG, Eye Movements, Learning Disorders, Myotonia, Zoster, in Lerner, A (ed): The Little Black Book of Neurology, ed 3. St.Louis, Mosby year Book, 1994.

Vandersluis, J: Diabetic Neuropathy, Post-herpetic Neuralgia, Trigeminal Neuralgia in Levine, M (ed): Drugs of First Choice. Ottawa, Canadian Medical Association Publishing, 1995.

Vandersluis, J: Book Review- Neurology Secrets: Questions You Will be Asked on Rounds, in the Clinic, on Oral Exams. Neurology 1994; 44: 199.

Neurology Grand Rounds: Post Herpetic Neuralgia, Mechanisms and Management. June 17, 1994 Case Western Reserve University, Cleveland, Ohio.

Case Western Reserve Medical School, Year II lecture: Neuralgias, Pathophysiology and Presentations, January 10, 1995.

Wright State Medical School, Department of internal Medicine lecture, AIDS and Nervous System, September 1995.

Wright State Medical School, department of Family Practice lecture: Management of Cephalgia, January 24, 1996.

Miami Valley Hospital and Good Samaritan Hospital Departments of Family Practice and Internal Medicine: Advances in Stroke Management; Use of Tissue Plasminogen Activator, multiple lectures, 1997.

Wright State Medical School, Department of Family Practice Lecture: Syncope, September 24, 1997.

Miami Valley Hospital, Family Practice Residency Lecture: Migraine Headaches, August 19, 1998.

Wilson Memorial Hospital, Department of Internal Medicine Lecture: Acute Stroke Management, September 2, 1998.

Second Annual Acute Issues in Internal medicine, Conference Day, Dayton Ohio: Advances in Acute Stroke Management, October 22, 1998.

Good Samaritan Hospital, Community Lecture Series, Senior Connection: Management of Stroke, October 1998.

Miami Valley Hospital, Grand Rounds: Stroke Management, November 18, 1998.

Good Samaritan Hospital, Community Talk, Senior Connection: Overview of Parkinson’s Disease and Management, March, 19, 1999.

Dayton Veteran’s Administration, Internal Medicine Lecture Series: Neuropathy – Assessment and Management, April 6, 1999.

Good Samaritan Hospital, Internal Medicine Lecture Series: Assessment and Management of the Acute Confusional State, July 29, 1999.

Dayton Veteran’s Administration, Internal Medicine Lecture Series: Stroke in the Young Patient, February 22, 2000.

Multiple Sclerosis Society, Montgomery County: Update in Multiple Sclerosis, October 28, 2000.

Facial Pain for the Dental Practitioner, Montgomery County Dental Society, September 9, 2002.

RESEARCH AND PROTOCOL DEVELOPMENT

"Warfarin vs. Aspirin in Reduced Cardiac Ejection Fraction Study" sponsored by National Institutes of Neurological Disorders and Stroke (NIH), 2003

"Carbatrol SPEQT Trial (Safety, Preference, Effectiveness, QoL, Tolerability)", Shire Pharmaceuticals, 2003.

"A Double-Blind, Placebo-Controlled Parallel Group, Dose Response Study to Evaluate the Efficacy and Safety of Compound versus Placebo in the Treatment of Pain Associated with Diabetic Peripheral Polyneuropathy." 1999-2000.

"A Randomized, Double-Blind. Parallel-Group, Monotherapy Study to Compare the Safety and Efficacy of Two Doses of Compound in the Treatment of Newly Diagnoses or Recurrent Epilepsy." 1999-2000.

"Pilot MRI Study of Compound in Ambulatory Subjects with Relapsing Multiple Sclerosis." 2000-2001.

Co-Investigator: Evaluation of the Efficacy and Tolerability of UCB L059 (Levetiracetam) Add-on Treatment in Epileptic patients with Partial Onset Seizures: A Thirty Eight (38) week Double-Blind Placebo-Controlled Parallel Group Multicenter Trial (UCB Protocol # RPCE94A1403).

Co-Investigator: Migramist in the Treatment of Acute Migraine Headache: A Double-Blind, Randomized, Placebo-Controlled Study to Determine The Effectiveness and Safety of Migramist (Dihydroergotamine Mesylate Nasal Spray) 2 mg for the Acute Treatment of Migraine Headache with or without Aura in Migraineur Families. (Sandox DHE-454).

Co-Investigator: A Randomized Double-Blind Multi Investigator Study of Once Daily Uniphyl 400 mg Tablets and Proventil Repetabs Twice Daily in Nocturnal Asthma (Purdue Frederick UN91-501).

Developed and Instituted Protocols for the use of Tissue Plasminogen Activator in Acute Stroke Management, Miami Valley and Good Samaritan Hospitals, 1997.

CURRICULUM VITAE

Raymond G. Mason, M.D.

EDUCATION

East Carolina University Family Practice Residency Program
Dates of attendance: 1997 to 2000
Area of concentration: Family Medicine
Graduation: June 2000

Case Western Reserve University School of Medicine
Dates of attendance: 1993-1997
Graduation: May 17, 1997

University of Akron
Post-baccalaureate courses in Chemistry, Physicsand Genetics
Dates of attendance: Fall 1991, Summer 1992

Bowling Green State University
Bachelor of Science in, Education
Major: Biology
Date of Graduation: .August 30, 1981

Ohio State University
Dates of attendance: 1978-1979
Major: Biology

EMPLOYMENT

Family Practice Center of Wooster
128 East Milltown Road Suite 205
Wooster, 44691

Medical Director
Hyperbaric Medicine &Wound Healing Center
Wooster Community Hospital
1761 Beall Avenue
Wooster, cat 44691

Family Medicine Associates of Medina, Inc.
970 East Washington Street #301
Medina, 44256

Pitt County Memorial Hospital/East Carolina University
Family Practice Residency Program
600 Moye Blvd.
Greenville, NC 27858

CERTIFICATION

American Board of Family Practice
Diplomat 2007-2014

HOSPITAL AFFILIATION

Wooster Community Hospital, Wooster, OH
Medina General Hospital, Medina, OH

HONORS

Award of Distinction, Family Medicine, Case Western Reserve University
Chief Resident, ECU family Practice Residen.cy Program 1999-2000

VOLUNTEER EXPERIENCE

Team Physician. Smithville High School 2007-2008
Team Physician, Norwayne High School 2002-2003
Team Physician, D.H.Conley High School 1997-1999
The Sports Medicine Center at Children's Hospital
Evaluation and Rehabilitation of Musculoskeletal Injuries
Akron, OH 1992

PRESENTATIONS

LIFE THREATENING INJURIES, Wooster, OH; August 2002-present
Wooster Community Hospital Sports Medicine Seminar for Coaches

STFM National Conference, Orlando FL; May 4-6, 2000

WCNT Morning Show, Channel 9, Greenville, NC; August 1997

President Care Conferences and EMB Conferences 1997-2000
Topics included STD's, Pediatric and Adult EBM reviews, Third Trimester
Bleeding, Exercise Induced Bronchoconstriction

Senior Partners
"Lining With Arthritis"

ORGANIZATIONS

AAFP, OAFP, AMA, OSMA

COMMITTEES

ECUFamily Residency Curriculum Committee

Chairman’s Advisory Committee

Residency Director Selection Committee

Resident Retreat Committee Chairman

Inpatient Service Committee

PERSONAL

Married: wife, Terri and 2 children, Jennifer and Kristin.

REFERENCES

Excellent references furnished upon request

CURRICULUM VITAE

Dora L. Richardson

6984 Lafayette Road
Medina, Ohio 44256
440-552-8698

OBJECTIVE:

By using my advanced education and clinical health care training in an innovative fashion, I will help provide information for all ages and give families and individuals the ability to make informed and educated decisions concerning their health care and lifestyle choices.

DEGREES AND CERTIFICATIONS:

Drug Enforcement Administration Authority, United States Department of Justice, 2003-Present
Prescription Authority, Ohio Board of Nursing, 2002-Present
Certificate of Authority, Ohio Board of Nursing, 1997-Present
Masters of Science in Nursing, Case Western Reserve University, Frances Payne Boulton, 1997
Nurse Practitioner – Certificate, American Academy of Nurse Practitioners, 1997
Bachelor of Science in Nursing, Ashland University, 1990
Registered Nurse, Ohio Board of Nursing, 1978-Present
Associate Degree of Nursing and Allied Health, Cuyahoga Community College, 1978
High School Diploma, Cuyahoga Heights High School, 1974

PROFESSIONAL EXPERIENCE:

AFTER HOURS FAMILY MEDICINE, LLC July 2010-Present
P.O. Box 47, 18 E. Main Street, Seville, Ohio 44273
Nurse Practitioner/Owner
Nurse Practitioner for family practice clinic offering low cost, high quality family health services at a convenient time in a hometown setting.

PROSEARCH HEALTH FORM 2005-Present
2503 Ruby Vale, University Heights, Ohio 44118
Nurse Practitioner
Contract Nurse Practitioner for various medical positions: Experience at Parma Community Hospital, Workmans
Compensation Clinic at Parma Community Hospital, Cleveland Correctional Facility in Highland Heights, Cleveland City
Jail in Downtown Cleveland. Provide medical services for illnesses, counseling.

INFINITY NP 2003-Present
26165 Detroit Road, Westlake, Ohio 44145
Nurse Practitioner
By focusing on clinical issues that impact quality of life for the elderly population by specializing in the
clinical, wound, pain, falls and dermatological management for clients in Long Term Care/Skilled Nursing facilities.

ERIDA HURON SCHOOL OF NURSING 2002-2003
13951 Terrace Road, East Cleveland, Ohio 44112
R.N.M.S.N., Clinical Instructor
Supervise and instruct students on the clinical units and in the labs by demonstrating expertise in the area of clinical practice by analyzing, applying knowledge, planning, implementing and evaluating student learning needs and patient care needs.

NORDONIA HILLS CLINIC, INC. 2002-2005
7689 Sagamore Hills Blvd., Sagamore Hills, Ohio 44067
Family Nurse Practitioner
Obtain medical histories and perform physical exams. Diagnose and treat acute health problems. Diagnose, treat and monitor chronic diseases. Order, perform and interpret diagnostic studies. Prescribe medications and other treatments in compliance to Nurse Practice Act S.B. 154. Provide prenatal care and family planning services. Provide well-child care, including screening and immunizations. Provide health maintenance care for adults. Promote positive health behaviors and self-care skills through education and counseling. Collaborate with physicians and other health professionals.

MEDINA COUNTY HEALTH CARE DEPARTMENT 1998-2003
4800 Ledgewood Dr., Medina, Ohio 44256
Family Nurse Practitioner
Obtain medical histories and perform physical exams. Provide health maintenance care for adults. Promote positive health behaviors through education and counseling.

FAMILY MEDICINE ASSOCIATES OF MEDINA 1996-2002
970 East Washington Street Ste. 301, Medina, Ohio 44256
Family Nurse Practitioner
Same as Nordonia Hills Clinic, Inc.

DR. JOHN MILLER AND DR. AMY JOLLIFF 1996-1997
128 Milltown Road, Wooster, Ohio 44691
Family Nurse Practitioner
Same as Nordonia Hills Clinic, Inc.

PROFESSIONAL ORGANIZATIONS:

Ohio Association of Advanced Practice Nurses - 5818 Wilmington Pike #300, Dayton, Ohio 45459
American College of Nurse Practitioners (ACNP) - 111 19th Street NW, Ste. 404, Washington, D.C. 20036

CURRICULUM VITAE

Robert V. Sibilia M.D.
324 E. Milltown Rd. Suite A
Wooster, Ohio 44691
Phone: (330) 345-2459
Fax: (330) 345-3756

UNDERGRADUATE EDUCATION:

Fairfield University
Bachelor of Science (1981-1985)
Major: Biology-Chemistry
Honors: Graduated Cum Laude
Alpha Epsilon Delta Honor Society
Research: Phopholipase A2 Enzyme Assay, research project at Fairfield University with Dr. Ross (1983-1989)

MEDICAL EDUCATION:

Loyola University of Chicago Strich School of Medicine M.D. (1985-1989)

Research/Monomer chemistry research on absorbable

Employment: suture material and oral Itraconazole. Ethicon Corporation, Summerville, N.J. (1986)

PROFESSIONAL TRAINING:

• Residency Training in combined Internal Medicine/Pediatrics, Albany Medical Center (1989-1993)
• Fellow, Adult Pulmonary Medicine, Albany Medical Center (1993-1995)
• Pediatric Pulmonary and Cystic Fibrosis Center, Albany Medical Center (1993-1994)

CLINICAL EXPERIENCE:

• Adult and Pediatric Pulmonary Practice, Wooster Clinic, Wooster, OH (1995-Present)
• Neonatal Intensive Care Unit, Albany Medical Center, Albany NY (1992-1993)
• In-hospital medical service coverage at St. Peter’s Hospital, Albany NY (1993)
• Solo Practitioner, Emergency Room, St. Mary’s Hospital, Troy, NY (1993)
• Solo Practitioner, Emergency Room, Stratton VA Medical Center, Albany, NY (1993-1994)
• In-hospital Medical Service Coverage, Stratton VA Medical Center, Albany, NY (1993-1994)
• Pediatric Bronchoscopy Course, University of North Carolina, Robert Wood, M.D., Instructor (8/94)

FACULTY APPOINTMENTS:

• Instructor of Pediatrics, Albany, Medical College (7/93-6/94)
• Attending Pediatrician, Pediatric Pulmonary and Cystic Fibrosis Center, Albany Medical Center (7/93-6/94)

EXAMINATIONS/LICENSURE:

• Board Certified – Pulmonary
• Board Certified –Internal Medicine
• Board Certified – General Pediatrics
• Licensure: Ohio (1995- Present)

PROFESSIONAL SOCIETIES:

• Candidate Fellow, American Academy of Pediatrics
• American Thoracic Society American College of Physicians

PUBLICATIONS:

• Case Presentation, ACP Meeting (1992) Second Place Award with Scholarship

SKILLED IN THE FOLLOWING PROCEDURES:

• Adult Bronchoscopy: Transbronchial, Endobronchial and Wang Needle Biopsy
• Pediatric Bronchoscopy: 3.5 mm Scope, Bronchial Alveolar Lavage
• 2.2 mm Scope for Neonates
• Thoracentisis: Adult and Pediatric
• Pulmonar Artery Catheter Placement Adult
• Arterial Line Placement: Adult and Pediatric
• Umbilical Artery and Vein Catheterization: Neonate
• Central Venous Access: Adult and Pediatric (Femoral, Subclavian, and Internal Jugular)
• Percutaneous Central Line (PIC): Adult and Pediatric
• Advanced Life Support: Adult and Pediatric
• Endotracheal Intubation: Adult, Pediatric, and Neonatal
• Oral, Nasal, over bronchoscope
• Ventilator Management: Adult and Pediatric
• Pulmonary Function Testing/Interpretation: Adult and Pediatric
• Preliminary Interpretation: Adult, Infant, and Pediatric
• Chest x-ray, Chest CT, Sinus
• Series, Airway Films Nasal
• Ciliary Motility Study
• Sweat Test Interpretation/Evaluation

Staff Expertise

Dynamic Mental Health, LLC

Clinical Trial Coordinator: Richard P. Yarbrough, LPCC
6302 Rosa Linda Drive
Dayton, Ohio 45459
(937) 435-4017 home (937) 620-7646 cell

Education

• May 1969 B.A. in Political Science, North Texas State University
• August 1971 M.S. in Clinical Psychology, North Texas State University License LPCC in Ohio

Employment Experience:

• November 2009-Present

Dynamic Mental Health Services
I work part time as a LPCC providing individual counseling to adults and children and doing intake interviews for the psychiatrist.

• April 2009 – Present

Springboro Medical Arts
I work part time as a LPCC providing individual counseling to adults and children and doing the intake interviews for the neuropsychiatrist.

• February 2005 – June 2009

PSI
I worked part time as a psychology assistant doing school psychology. I was at Life Skills in Dayton for one year doing psychological evaluations on high school students suspected of having a disability that interfered with their ability to learn. I also did psychological evaluations on students who are being home schooled through OHDELA. In addition to OHDELA students, also work one to two days a week at Heir Force, a charter elementary school in Lima.

• May 2003 – March 2009

Gordon Harris & Associates
I worked as a psychology assistant two days a week. My duties were testing children, adolescents, and adults to determine their eligibility for SSI. I also work under my counseling license seeing children, adults, couples and families.

• February 1996 – January 2004

Self Employed
During this time I did some private practice counseling. I purchased a laundromat and a convenience store, and I owned some residential and commercial rental properties

• April 1976 – January 1996

Catholic Social Services
I was responsible for providing counseling to individuals, couples, families, children, adolescents, and the elderly. I coordinated the Share-A-Home program and initiated an outreach counseling service for the elderly and disabled in Greene County. I also presented some psycho educational programs. I n addition to my clinical responsibilities, I served on the Personal Practices Committee and chaired it for one year.

• December 1974 – March 1976

Good Samaritan Mental Health Center
My duties included providing treatment to children, twelve years of age or younger and their families. Services provided were play therapy, child group therapy, marital therapy, family therapy, individual adult therapy and multi-family group therapy.

• September 1971 -- October 1974

Region VI Child Guidance Center, Lawton, Okla.
My duties included providing psychological evaluations and counseling to children, adolescents, and adults. Most children were seen in play therapy.

Additional Training
I have experience with bodywork therapies, such as bioenergentics. I completed a three-year training group in Gestalt Therapy. I also completed the first year of family therapy training with Ernie Andrews in Cincinnati. I began a training program in energy psychology (EFT and Quick Remap) and completed the first year of a three-year training program in NLP and Ericksonian hypnosis with David Santora in the Cleveland area. I have training in behavioral medicine through NICABM and Herbert Benson’s seminar. From 1982 to 1990 completed fifty-five graduate quarter hours when I was working toward a doctorate at Ohio State University. I did a research study through OSU on laterality in multiple personality disorder and presented the results at the Second International Conference on Multiple Personality/Dissociative States in Chicago in 1985.

Michael B. Lee, DDS
Coordinator: Sandy Tagher, RN
email: sandytagher@yahoo.com

EDUCATION:

Associate Degree in Nursing, Northern Kentucky University, 1992.

EMPLOYMENT:

2005-present
Registered Nurse, Dr. Michael B. Lee DDS
Responsibilities include administering anesthesia to patients receiving oral surgery in an office setting, pre and postoperative teaching, obtaining lab work and clearances for patients needing oral surgery.

2003-2005
Registered Nurse, The Christ Hospital, Operating Room
Responsibilities include circulating or scrubbing during surgery, patient safety, and documenting.

1997-2003
Registered Nurse, The Christ Hospital, CVNR
Responsible for the care of pre-op, intra-op, and post-op open heart surgery patients. Duties include insertion of invasive lines (arterial and internal jugular), assisting anesthesia with administration of vasoactive infusions and recovery of post-op surgery patients.

1994-1997
Registered Nurse, The Christ Hospital SICU
Responsibilities included taking care of general surgery, neurosurgery, vascular surgery, kidney transplant and medical patients.

1992-1994
Registered Nurse, University of Kentucky
Chandler Medical Center CTICU
Responsibilities included care of post-op open heart, lung transplant, heart transplant, vascular surgery, and trauma patients.

Joel Vandersluis M.D., F.R.C.P.C.
Clinical Trial Coordinator: Grace Smither

RESEARCH CURRICULUM VITAE

Neurology Diagnostics, Inc.
1ST Floor, Suite B
Dayton, Ohio 45417
937-224-8200

QUALIFICATIONS SUMMARY

Responsibilities included:

• Provide and manage long-term, comprehensive medical care, including diagnosis and nonsurgical treatment of diseases, for adult patients in an office or hospital.
• Collect, record, and maintain patient information, such as medical history, reports, and examination results.
• Analyze records,reports, test results, or examination information to diagnose medical condition of patient.
• Prescribe or administer medication, therapy, and other specialized medical care to treat or prevent illness, disease, or injury.
• Explain procedures and discuss test results or prescribed treatments with patients.
• Monitor patients' conditions and progress and reevaluate treatments as necessary.
• Advise patients concerning diet, activity, hygiene, and disease prevention.
• Refer patient to medical specialist or other practitioner when necessary.
• Advise surgeons of a patient's risk status and recommend appropriate intervention to minimize risk.
• Provide consulting services to other doctors caring for patientswith special or difficult problems.

Over 10 years of experience in Internal Medicine and General Practice

Training in a veterans’ hospital reflects 3 years of exposure to geriatric medicine

Affiliate Member, Philippine College of Physicians

Oral certifying examinations, Philippine Board of Internal Medicine, November 2000

Philippine Medical licensure examinations August 1995, Manila, Philippines

PROFESSIONAL EXPERIENCE

Neurology Diagnostics, Inc., 1ST Floor Suite B
Dayton, Ohio 45417
Clinical Research Coordinator
July 2012 to Present

MD Eastwood Medical and Wellness Center, 3F
Cybermall Bldg
Eastwood City, Libis
Quezon City, Philippines
Internist
July 2006 to March 2009

Fortune Medicare, Inc., Rm. 207
Marian Medical Arts Bldg.
Dahlia Ave.
Fairview, Quezon City, Philippines
Internist
March 2004 to March 2009

Bernardino General Hospital
Zabarte Road
Novaliches, Quezon City, Philippines
Visiting Physician
March 2004 to March 2009

Far Eastern University - Nicanor Reyes Medical Foundation, Regalado cor.
Dahlia Ave.
Fairview, Quezon City, Philippines
Visiting Physician, Internal Medicine
January 2001 to March 2009

Prime Care Options, Inc., 2F
Novaliches Plaza Mall
Novaliches, Quezon City, Philippines
Internist
December 2000 to July 2003

Veterans Memorial Medical Center
North Avenue
Quezon City, Philippines
Resident, Internal Medicine
August 1997 to December 2000

Armed Forces of the Philippines Medical Center
V. Luna Road
Quezon City, Philippines
Post-graduate medical intern
May 1994 to April 1995

Fairview General Hospital
Fairview Avenue
Quezon City, Philippines
Part-time General Practice, Emergency Room Physician
September 1995 to July 1996

Fairview General Hospital is a small hospital which caters to mostly simple, uncomplicated cases. Being the only hospital then in a 20-mile radius from middle- to low-income communities, patients requiring more intensive care are referred to tertiary-care facilities after they are stabilized. The emergency room physiciantends to a wide range of cases, from the simple cough and cold to cases of impending cardio-respiratory arrest. Promptly refers to a medical specialist for complicated cases. Performs minor surgical procedures under the supervision of the on-call surgeon. Orders diagnostic examinations if warranted and creates a treatment plan that is discussed with the patient.

EDUCATION

University of Santo Tomas Faculty of Medicine and Surgery, Manila, Philippines
Doctor of Medicine, February 1995

University of Santo Tomas College of Science, Manila, Philippines
Bachelor of Science Major in Biology, March 1990

RESEARCH

Clinical Research Coordinator 2012: A 12-month, Prospective, Randomized, active-controlled, open-label study to Evaluate the patient retention of two first-line disease modifying therapies in adults who are in Early stages of treatment for Relapsing remitting multiple sclerosis.

Raymond G. Mason:
Clinical Trial Coordinator: Kim Byrne, RN

Experience:

EMPLOYMENT:

• Family Practice Center of Wooster 2012-Present
  Clinical Research Coordinator
• Novartis Pharmaceuticals 2005- 2012
• Neuro-Psych Specialist 2010-2012
• Mass Market sales representative 2005-2010
• Biovail Pharmaceuticals 2001-2005
• Mass Market sales representative 2001-2005
• Thomas Memorial Hospital (South Charleston W.V.) 1996-2001
  Registered Nurse

EDUCATION:

The Ohio State University
West Virginia State University

NURSING LICENSE:

Ohio Board of Nursing-R.N. #300003

RESEARCH:

• 2012 Clinical Research Coordinator: Phase II - A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study in Adult Subjects with Partly Controlled and Uncontrolled Asthma
• 2012 Clinical Research Coordinator: Safety and Efficacy Evaluation of an Otic Suspension in the Treatment of Acute Otitis Externa
• 2012 Clinical Research Coordinator: Cross-sectional, Observational Study to Evaluate COPD Severity Using Spirometry and Physician and Patient Assessments

Patient Demographics

Dynamic Mental Health LLC, with main offices in Cincinnati, is affiliated with other office locations in Dayton. Their locations offer the opportunity to easily recruit clinical trial subjects in Cincinnati and Dayton, as well the broader Ohio-Kentucky-Indiana tri-state region. Dynamic Mental Health serves both pediatric and adult populations.

Dr. Michael Lee, DDS is located centrally in the Cincinnati area, offering the opportunity to recruit clinical trial subjects in Cincinnati, as well the Ohio-Kentucky-Indiana tri-state region. Dr. Lee serves both pediatric and adult populations.

Other Information

Clinical Trial Developers sites use a central IRB at all times. The sites affiliated with Clinical Trial Developers, Inc. (CTD) have all taken CITI training as well as the CTD research preparation course, and ongoing site support. CTD is dedicated to patient safety, our sites reflect this attitude by remaining patient focused.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.