Stephanie Thomas, Research Director



Office Address:
Urology Center of Columbus, LLC
1021 Talbotton Road
Columbus, GA 31904

Southeastern Medical Research Institute
2100 North Avenue-A
Columbus, GA 31904
(706) 243-3669
(706) 324-7080 fax
 
Other Contact Information
thomass@harperurology.com
Pager# (866) 898-7770
 
Education:
Chattahoochee Valley Community College
Phenix City, Alabama 1990-1995
Licensed Practical Nurse

Troy State University
Phenix City, Alabama 2006-present
Business Administration
 
Professional Experience:
2004-Present Research Director. Southeastern Medical Research Institute
Research Director and certified clinical research coordinator in charge of overseeing all clinical research and quality assurance.
2003-2004 Certified Clinical Research Coordinator. Columbus Research Foundation
Study coordinator for William M. Harper IV, MD (Urologist).
2001-2003 Clinical Research Coordinator. Columbus Research Foundation, Inc. Study coordinator for two physicians, Steve Leichter, M.D. and William M. Harper IV, M.D.
1999-2000 Staff Nurse, Columbus Regional Healthcare Systems Dr. James Zumstein-EKG’s, venapuncture, assist with surgical procedures, insurance referrals, general nursing care.
1996-1999 1996-1999 Resident Care Manager, Care Center of Opelika
Supervisor of a 51-bed Medicaid unit, staff education, monitoring compliance of OSHA, Federal and State regulations, Safety and Quality Assurance Audits, monitor job performance of staff nurses and CNA’s
For three shifts of Unit 2, MDS assessments and care planning, wound care, drug screens.
1995-1996 1995-1996 Staff Nurse Canterbury Health Facility
Medication pass, wound treatments, supervision of CNA’s, generalized nursing care.
 
Credentials:
1995 LPN License-Alabama 2-044285 (Inactive)
2002 LPN License- Georgia LPN064043
CPR Training 5/15/2002-5/14/2004
SAF T PAK Certificate of Training 09/30/2002-09/30/2004
Certified Clinical Research Coordinator (ACRP)
 
Continuing Education:
AAPP GCP Course November 6 and 7, 2004
SCR GCP Course March 7-9, 2003
ACRP Annual Conference 2005
Managing a Clinical Research Business (Research Dynamics) September 21-23, 2004
SUNA Conference 2004
Seminar: The FDA Inspection Process Directly from the FDA” (ACRP) 90 minutes 9/16/2004
Seminar: HIPAA Security for Clinical and Database Research” (ACRP) 90 minutes 9/29/2004
Seminar: ACRP Atlanta Chapter Educational Program 6 credit hours 7/29/2006 Atlanta, GA
 
Professional Societies
Pediatric Endocrine Nurses Society
Society of Urologic Nurses & Associates
PENS Conference Planning Committee
National ACRP
Endocrine Nurses Society
West Central GA Chapter American Red Cross
Atlanta Chapter ACRP
Member
Member
Committee Member
Member (150255)
Member
Volunteer Nurse
Member
April 2002-2003
March 2002-Present
2002
2003-Present
June 2004 – present
2005-present
2005-present
 
Research
 
Endocrinology

Growth Hormone in Adults and Children

Protocol: 85-036. Genetech Pharmaceuticals. 2001
Genetech Growth Study (NCGS) Post Marketing Surveillance Program for Nutropin Depot [somatropin (rDNA origin) for injectable suspension], Nutropin AQ [somatrem (rDNA origin) for injection], Nutropin [somatrem (rDNA origin) for injection] and Protropin [somatrem for injection].

Protocol: 85-036EXT. Genetech Pharmaceuticals.
National Cooperative Somatropin Surveillance (NCSS) of Nutropin AQ and Nutropin Replacement Therapy in adults with Growth Hormone Deficiency.

Protocol: B9R-MC-GDGA Eli Lilly Pharmaceuticals 2003
The Hypopituitary Control and Complications Study

Research cont’dProtocol: B9r-EW-GDFC (GeNeSIS)
The Genetics and Neuroendocrinology of Short Stature International Study

Diabetes

Protocol: HGH 2149. Novo Nordisk Pharmaceuticals. 2001
Norditropin Therapy: the relationship of safety and efficacy to Insulin-like growth factors. An open-label, multicenter, post-marketing Pharmacodynamic and Pharmocoeconomic Study.

Protocol: 01-00-TL-OPI-501. Takeda Pharmaceuticals America, Inc. 2002
A double-blind, randomized comparison study of the long term (2-yr) safety and efficacy of ******** HCI or ************ in subjects with Type II Diabetes Naïve to Pharmacologic Therapy.

Protocol: AGEE-2138. Novo Nordisk Pharmaceuticals, Inc.
******* versus ********* in combination with Metformin, comparative efficacy and safety: An open-label, randomized, parallel group, multicenter study in the treatment of subjects with Type II Diabetes inadequately controlled with Sulfonylurea or Metformin Monotherapy or Low-Dose Glucovance.

Protocol: HOE901/40333. Aventis Pharmaceuticals. 2002
Impact of point-of-Care vs, Laboratory Testing of hemoglobin A1c (HbA1c), and Intense vs. Standard Monitoring titration Algorithm Adherance on Glycemic Control in Type II Diabetes subjects, who are inadequately controlled on oral Anti-Hyperglycemic Therapy, and starting ******** (insulin Glargine {rDNA Origin} injection): A 2x2, randomized, open-label trial.

Protocol: 2993-115. Amylin Pharmaceuticals. 2002
Phase III, randomized, triple-blind, parallel-group, long-term, placebo-controlled, multicenter study to examine the effect of Glucose Control (hbA1c) of AC2993 given twice daily in subjects with Type II Diabetes Mellitus treated with Metformin and a Sulfonylurea.

Protocol: 2993-115. Amylin Pharmaceuticals. 2003

Protocol: AC137-155E Amylin Pharmaceuticals 2003

Osteoporosis/Osteopenia

Protocol: ZOL446H2310. Novartis Pharmaceuticals Corporation. 2002
Multinational, multicenter, double-blind, randomized, placebo-controlled, parallel group study comparing the efficacy of Intravenous ************* in preventing secondary Osteoporotic Fractures after a hip fracture.

Urology

Bladder Cancer


Protocol: DFMO341. Ilex Oncology Services. 2001
Phase III randomized, double-blind study of ******* vs. Placebo in low-grade superficial bladder cancer.

Research cont’d

Benign Prostatic Hyperplasia/Prostatitis

Protocol: Alfaurus EFC4428. Sanofi-Synthelabo Research. 2001
A double-blind randomized parallel group study of ********* 10mg OD vs Placebo in the management of acute urinary retention in patients with a first episode due to BPH.

Protocol: L8890 Sponsor- Sanofi Synthelabo 2004
Prospective, observational registry and patient survey of the management of men with symptomatic benign Prostatic hyperplasia.

Erectile Dysfunction

Protocol: MF SHIMMED Study. William M. Harper IV, M.D. 2001 Independent Trial
Minority Focused Sexual Health Inventory for Men as Model for Evaluation and Detection of Men’s Health Issues.

Protocol: M01-296. TAP Pharmaceuticals. 2002
A Phase III, 12-month, open-label, felixble dose, safety extension study of ******** tablets (2 and 3mg) in the treatment of male erectile dysfunction.

Protocol: H6D-MC-LVFN(b) Eli Lilly and Icos Pharmaceuticals 2003
An Open-Label Study to Evaluate the Efficacy and Safety of Tadalafil Administered “On Demand” to Men of Various Populations with Erectile Dysfunction.

Prostate Cancer

Protocol: MPR-7869-001 Myriad Pharmaceuticals 2003
Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of MPC-7869 in Delaying the Systemic Progression of Prostate Cancer in Patients with Intermediate to High Risk of Recurrence with Rising PSA Levels After Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease.
Myriad Pharmaceuticals 2002.

Protocol: TBC-PRO-002 Therion Pharmaceuticals 2003
A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of **********/********* in Combination with GM-CSF in Patients with Androgen-Independent Adenocarcinoma of the Prostate.

Protocol: L8891 Sanofi-Synthelabo 2004
Prospective, Observational Registry of the management of men with prostate cancer and a rising PSA following surgical or radiological treatment of the primary tumor.

Protocol: G300203 GTX Inc. 2005
A randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety of ***** ** for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy.

Protocol: 20050147 Amgen Inc. 2005
A Randomized, Double-blind, Placebo-Controlled, Multi-center Phase 3 Study of ******** on prolonging bone metastasis-free survival in men with hormone-refractory prostate cancer.

Protocol: 20050103
A Randomized, Double-Blind, Multicenter study of ******** Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer.

Research cont’dAdult Growth Hormone Deficiency

Protocol: 85-036EXT. Genetech Pharmaceuticals.
National Cooperative Somatropin Surveillance (NCSS) of Nutropin AQ and Nutropin Replacement Therapy in adults with Growth Hormone Deficiency.

Protocol: X3397n Genentech Pharmaceuticals. 2005 Independent Study
The incidence of Adult Growth Hormone Deficiency secondary to pituitary adenomas of head trauma in hypogonadal males presenting in the urological practice.

Protocol: L3339n Genentech Pharmaceuticals. 2005
Genentech National Cooperative Metabolic Study (NCMS) of Nutropin AQ [somatropin (rDNA origin) injection] and Nutropin [somatropin (rDNA origin) for injection] replacement therapy in adults with growth hormone dysfunction.

Stress Urinary Incontinence/Overactive Bladder

Protocol: F1J-US-SBCD Eli Lilly and Omnicare Pharmaceuticals 2003
Study of Duloxetine HCI in Women of Different Demographic Characteristics and Co-morbidities with Stress Urinary Incontinence: Evaluation of Efficacy and Safety.

Protocol: A6121120 Pfizer Pharmaceuticals 2005
A randomized, double-blind, placebo controlled, four arm (*****, *****, *****, and ***** plus *****) study to evaluate the clinical efficacy and safety of ***** in men who have frequency and urgency, with or without urinary urge incontinence, with or without bladder outlet obstruction.

Urinary Tract Infections

Protocol: CAPSS-292 Ortho-McNeil Pharmaceuticals 2004
Randomized, Parrellel Group Trial of ****** extended release tablets or placebo in combination with ***** for the treatment of lower urinary symptoms.

Protocol: CAPSS-349 Ortho-McNeil Pharmaceuticals 2005
A Study to Compare the Safety and Efficacy of Once Daily ****** versus Twice Daily ***** in the Treatment of Complicated Urinary Tract Infection and Acute Uncomplicated Pyelonephritis.

OB/GYNProtocol:15-50310 Hormos Medical Corporation 2006
Efficacy and safety of ******** in the treatment of vulvar and vaginal atrophy (VVA) in postmenapausal women: A 12-week, randomized, double-blind, placebo-controlled, parallel-group study comparing oral ***** and *** and *** daily doses with placebo.

Protocol: 15-50310x
Long-Term Safety of ******* and ****** Oral Daily Doses of ****** in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women with an Intact Uterus: A 40-Week Randomized, Double-Blind, Placebo-Controlled, Follow-Up to Protocol 15-15310.

Protocol: 15-50312
Long-Term Safety of ******* Oral Daily for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women without an Uterus: A 52-Week Open-Label Follow-Up to Protocol 15-15310.

Articles Published

Thomas S and Leichter SB: Combination Medications in Diabetes Care: An Opportunity That Merits More Attention . Clinical Diabetes. Volume 21, Number 4, 2003. Pg 175-178