Clinical Trial Developers, Inc.
5807 Needleleaf Drive
Milford, Ohio 45150
513-575-0863 http://www.clinicaltrialdevelopers.com brigney@clinicaltrialdevelopers.com

Use our guide to learn which trials are right for you!

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 seven years of experience in the research arena and over 23 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.

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

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

  • Extractions
  • Wisdom Teeth
  • Implants
  • Fractures
  • Bone Grafts
  • Orthognathic Surgery

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

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

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: Sandra Tagher
11755 Dixie Highway
Walton, KY 41094
H (859)485-4880
C (859)815-9920
e-mail sandytagher@yahoo.com

EDUCATION:

  • Associate Degree in Nursing, Northern Kentucky University, 1992.

EMPLOYMENT EXPERIENCE:

  • 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.

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.


Dental/Maxillofacial Surgery
Psychiatry/Psychology

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


Beth A. Rigney
President and CEO
Clinical Trial Developers, Inc.
5807 Needleleaf Drive
Milford, OH 45150
USA
513-575-0863
513-575-0862 (fax)
brigney@clinicaltrialdevelopers.com
www.clinicaltrialdevelopers.com


We've found
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at this facility
Lung Cancer (Diagnosis) Clinical Trial
Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically Diagnosed Lung Cancer
Status: Enrolling, Phase
Updated: 12/31/1969
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Milford, OH
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