Center for Pharmaceutical Research - An AMR Company -- Tomorrow's Medicines Today

Total number of previous allergy/asthma studies:

● 5 Asthma studies

● 5 Allergy studies

● 1 Dust Mite Allergy study

● 2 Ragweed Allergy study

● 1 Timothy Grass Allergy study

● 1 Cat Allergy study

Patient Population:

● Over 11,113 patients with asthma in our databases

● Over 8,125 patients with allergic rhinitis in our databases

● Pediatric, adolescent, adult, and geriatric patient populations

● Population includes mild, moderate, and severe asthma patients

Specialized Equipment and Staff:

● Spirometer (calibrated annually)

● Board-certified allergist investigator

● Board-certified pulmonologist investigator

● Coordinator with 7 years’ experience in allergy and immunology

Historical Statistics

Condition	Population	Enrollment Goal	Actual Enrollment	% of Enrollment Goal Met
Ragweed Allergy	Adults	10	18	180%
Ragweed Allergy	Adults	12	15	125%
Asthma	Pediatric	8	8 so far	ongoing
Asthma	Adults	8	7 so far	ongoing
Dust Mite Allergy	Adolescents	9	ongoing	ongoing

Total number of previous Alzheimer’s disease studies:

● 10 Alzheimer’s Disease studies

Patient Population:

● Over 1,411 patients with Alzheimer’s disease in our databases

Specialized Equipment and Staff:

• 2 coordinators with over 15 years of Alzheimer’s disease clinical trial experience
• 4 experienced raters and psychometricians. These professionals have been specifically trained to administer tests to Alzheimer’s patients and caregivers with the utmost care and sensitivity

Please see below for a list of some of the scales and evaluations we have previously administered:

NINCDS/ADRADA	DSM-IV	MMSE	Rosen Modified Hachinski	Ischemic Score
NTB	DAD	ADAS-COG	CDR-SOB	NPI
DS	RUD-Lite	QOL-AD	PPQSA	HUI

● Comfortable infusion room with leather chairs, TV, DVD player, plants, etc.

● Infusion team, directed by our Nurse Practitioner

● Crash cart in infusion room

● 3.0 Tesla MRI and 1.5 Tesla MRI

● PET and CT Scan

Historical Statistics

Condition	Severity	Enrollment Goal	Enrollment Total	% of Enrollment Goal Met
Alzheimer's Disease	Mild to Moderate	7	13	186%
Alzheimer's Disease	Mild to Moderate	6	7	117%
Alzheimer's Disease	Mild to Moderate	8	6	75%
Alzheimer's Disease	Mild to Moderate	No Goal	10	100%

Total number of previous dermatology studies:.

● 7 Psoriasis

● 1 Rosacea

● 1 Acne

● 3 Skin Infection

● 3 Herpes Zoster

Patient Population:

● 551 volunteers with psoriasis in our research database alone

● 342 volunteers with rosacea in our research database alone

● Large dermatology private practice database available for recruitment

Specialized Equipment and Staff:

● Board-certified dermatologist investigators

● High-resolution digital camera and color printer

● Experienced PASI raters on staff

Historical Statistics

Condition	Length of Enrollment	Total # Screened	Total # Enrolled
Psoriasis	2 months	14	11
Psoriasis	1 month	10	9
Rosacea	3 months	20	18
Skin Infection	5 months	9	9
Skin Infection	Unk	20	15

Total number of previous diabetes/diabetic peripheral neuropathy studies:

● 12 Type II Diabetes studies

● 1 Type I Diabetes study

● 1 Diabetic device study

● 1 Diabetic Foot Ulcer study

● 10 Diabetic Peripheral Neuropathy studies

Patient Population:

● Over 915 volunteers with DPN in our research database

● Over 2,696 volunteers with Diabetes in our research database

● Pediatric, adolescent, adult, and geriatric patient populations

Specialized Equipment and Staff

● Board-certified endocrinologist sub-investigators

● Board-certified neurologist sub-investigators

● 3 groups of family practice sub-investigators

● 3 Registered Dieticians

Historical Statistics

Condition	Enrollment Length	Enrollment Goal	Enrollment Total	% of Enrollment Goal Met
Diabetes / Hypertension / Obesity	2 months	8	13	163%
DPN	8 months	6	8	133%
DPN	11 months	10	10	100%
Type II Diabetes	23 months	25	48	192%
DPN	unknown	6	17	283%
DPN	8 months	6	8	133%
DPN	7 months	5	9	180%

Total number of previous fibromyalgia studies:

● 10 fibromyalgia studies

Patient Population:

● Over 825 volunteers with fibromyalgia in our research database alone

Specialized Equipment and Staff

● Our staff is experienced in the use and administration of the following fibromyalgia assessment tools, among others:

ASEX	Medical Outcomes Study- Sleep Scale (MOS)
BDI	Multidimensional Assessment of Fatigue (MAF)
BDI-II	Hospital Anxiety and Depression Scale (HADS)
F-HAQ	MINI Mental State Examination
FIQ	Beck Depression Scale
HAM-D	Workload Productivity and Activity Impairment Questionnaire
MASQ	Profile of Mood States
MFI	EuroQol Utility Assessment
SDS	Patient Global Impression of Change
SF-36	SF-MPQ

Historical Statistics

Phase	Enrollment Length	Enrollment Goal	Recruitment Total	Number Enrolled	Percentage of Enrollment Goal Met
3	7 months	10	47	20	200%
3	7 months	10	11	11	110%
unk	1 month	8	11	10	125%
3	4 months	9	22	11	122%

Total number of previous gastrointestinal studies:

● 8 Gastroduodenal Ulcer studies

● 6 Opioid Induced Constipation studies

● 1 Chronic Idiopathic Constipation study

● 5 Erosive Esophagitis/Heartburn studies

● 4 Irritable Bowel Syndrome studies

● 1 H. Pylori study

Patient Population:

● 212 volunteers with gastroduodenal ulcers in our research database

● 347 volunteers with constipation in our research database

● 2,282 volunteers with Erosive Esophagitis/Heartburn in our research database

● 972 volunteers with Irritable Bowel Syndrome in our research volunteer database

● Pediatric, adolescent, adult, and geriatric patient populations

Specialized Equipment and Staff

● Board-certified gastroenterologist sub-investigator on campus

Historical Statistics

Condition	Enrollment Length	Actual Enrollment	Enrollment Goal	% of Enrollment Goal Met
Gastroduodenal Ulcer/OA/RA	2.5 months	43	40	107.50%
Gastroduodenal Ulcer/OA	7.5 months	17	11	154.55%
Gastroduodenal Ulcer/OA	4 months	12	6	200.00%
Gastroduodenal Ulcer/OA	3 months	8	1	800.00%
Erosive Esophagitis	unk	4	4	100.00%
Erosive Esophagitis	4 months	7	6	116.67%

Total number of previous Healthy Volunteer studies:

● Vaccine Studies:

• 1 Anthrax vaccine (adult)

• 5 Avian flu vaccine (adult)

• 1 Botulism vaccine (adult)

• 1 Plague vaccine (adult)

• 2 DTP vaccine (adult)

• 1 Pediatric DTaP/IPV vaccine (pediatric)

• 20 Adult/elderly influenza vaccine (adult and geriatric)

• 4 Herpes zoster (adult)

• 2 Swine flu vaccine (adult)

• 2 Infant meningitis vaccine

• 2 Meningitis vaccine (infant)

• 3 Meningitis vaccine (pediatric, adolescent, and adult)

• 1 Influenza vaccine (pediatric)

• 1 C. Difficile vaccine (adult)

• 1 HPV vaccine (adolescent, adult)

• 1 Melanoma vaccine (adult)

• 4 Pneumonia vaccine (adult)

• 3 Hepatitis B vaccine (adult)

• 2 MMR vaccine (infants)

● Other Indications:

• Blood draw studies

• Observational men’s health studies

• Flu Treatment studies

• Heartburn studies

• Diabetic device studies

• X-ray studies

• Birth control studies

• Semen analysis studies

• Flu swab/diagnostic

Patient Population:

● 4,200 volunteers ages birth to 1 year

● 5,600 volunteers ages 1 year to 2 years

● 6,400 volunteers ages 2 years to 5 years

● 5,600 volunteers ages 6 years to 11 years

● 6,200 volunteers ages 12 to 18

● 14,477 volunteers ages 18 years to 64 years

● 8,627 volunteers ages 65+

Specialized Equipment and Staff

● Separate unblinded pharmacy team

● 2 (2-8° C) locked drug refrigerators

● 1 (-20° C) locked drug freezer

● 1 (-70° C) locked drug freezer

● Overnight stay capabilities

● 4 temperature monitoring systems in each drug storage space

● Bio-Safety Level 2 certified

● Local IBC committee available

● PBMC sample experienced/capable

● Have served as the only site in the country for multiple phase I vaccine clinical trials

Total number of previous allergy/asthma studies:

● 20 High Cholesterol studies

Patient Population:

● Over 10,810 patients in our databases have high cholesterol

Specialized Equipment and Staff

● Board-certified endocrinologist investigator

● Board-certified cardiologist investigators

● 4 coordinators with cardiology/telemetry backgrounds, with over 25-years combined cardiology experience

● Phillips 3.0 Tesla MRS (Magnetic Resonance Spectroscopy). MRS provides quantitative hepatic triglyceride levels. Our facility is unique in the region in offering this cutting-edge technology

● Mercury sphygmomanometers and electric sphygmomanometers (calibrated annually)

● Cholestec machine

Historical Statistics

Description	Enrollment Goal	Actual Enrollment	% of Enrollment Goal Met
Mixed Dyslipidemia	6	11	183.33%
Hyperlipidemia	20	38	190.00%
Dyslipidemia	10	17	170.00%
Hypercholesterolemia	10	18	180.00%
Hypercholesterolemia	10	26	260.00%
Hypercholesterolemia	12	40	333.33%
Hypercholesterolemia	4	7	175.00%
Dyslipidemia	20	28	140.00%
Dyslipidemia	12	15	125.00%

Total number of previous hypertension studies:

● 13 previous hypertension studies

Patient Population:

● Over 9,838 patients in our databases have hypertension

Specialized Equipment and Staff:

● Board-certified endocrinologist investigator

● Board-certified cardiologist investigators

● 4 coordinators with cardiology/telemetry backgrounds, with over 25-years combined cardiology experience

● Mercury sphygmomanometers and electric sphygmomanometers (calibrated annually)

Historical Statistics

Condition	Length of Enrollment	Sponsor's Enrollment Goal	Number of Subjects Screened	Number Actually Enrolled	% of Enrollment Goal
High Risk Hypertension	13 months	12	15	11	92%
High Risk Hypertension	13 months	12	21	17	142%
Hypertension/ Obesity/Diabetes	14 months	8	25	13	163%
Hypertension	3 months	5	24	23	460%
Mild to Moderate Hypertension	Not Available	12	78	24	200%
Mild to Moderate Hypertension	Not Available	6	6	6	100%

Total number of previous Men’s Health studies:

● 8 Premature Ejaculation studies

● 5 Erectile Dysfunction studies

● 8 Benign Prostatic Hyperplasia studies

● 1 Hypogonadism study

Patient Population:

● 525 volunteers with erectile dysfunction in our research volunteer database

● 473 volunteers with premature ejaculation in our research volunteer database

● 709 volunteers with benign prostatic hyperplasia in our research volunteer database

● 527 male volunteers with hypogonadism in our research volunteer database

Specialized Equipment and Staff

Our experienced coordinators understand the sensitive nature of men’s health studies and go out of their way to make the subjects feel comfortable. In addition, our staff includes board-certified urologist sub-investigators. The Center for Pharmaceutical Research routinely conducts the following tests and men’s health assessment tools and tests, among others:

● IIEF Questionnaire

● Hospital Anxiety and Depression Scale

● MINI Mental State Examination

● Beck Depression Scale

● International Prostate Symptom Score

● International Index of Erectile Dysfunction

● Hamilton Rating Scale for Depression

● Hamilton Anxiety Rating Scale

Historical Statistics

Condition	Length of Enrollment	Sponsor's Enrollment Goal	Number of Subjects Screened	Number Actually Enrolled	% of Enrollment Goal
Premature Ejaculation	3 months	10	66	66	660%
Premature Ejaculation	6 months	10	43	27	270%
Premature Ejaculation	1 month	8	32	22	220%
Premature Ejaculation	7 months	10	61	46	460%
Premature Ejaculation	8 months	10	35	35	350%
Premature Ejaculation	5 months	10	31	24	240%
Premature Ejaculation	6 months	No Goal	40	36	No Goal
Erectile Dysfunction	2 months	16	32	20	125%
Erectile Dysfunction	7 months	No Goal	25	25	No Goal
BPH	8 months	2	17	17	850%
BPH	3 months	9	23	12	133%

Total number of previous migraine studies:

● 18 Migraine studies

Patient Population:

● 2,293 volunteers with migraines in our research volunteer database

Specialized Equipment and Staff:

● Board-certified neurologist investigator

Historical Statistics

Enrollment Length	Total Enrollment	Enrollment Goal	% of Enrollment Goal Met
1 month	23	8	288%
1 month	23	10	230%
4.5 months	30	10	300%
5.5 months	25	10	250%
unk	45	25	180%
2 months	35	20	175%

Please contact Missy MacPhail at 816-943-0770 for more information about experience in this therapeutic area.

Total number of previous Neuroscience and Psychiatry studies:

● 13 Insomnia studies

● 5 Major Depressive Disorder studies

● 2 General Anxiety Disorder studies

● 1 ADHD study

Patient Population:

● 2,557 volunteers with insomnia in our research volunteer database

● 1,137 volunteers with major depressive disorder

● 875 volunteers with generalized anxiety disorder

● 228 volunteers with ADHD

Specialized Equipment and Staff:

● Board-certified psychiatrist investigator

● Doctorate-level psychologist investigator

● 6 experienced raters/psychomatricians

Total number of previous Obesity studies:

● 12 Obesity studies

Patient Population:

● 10,344 volunteers with a BMI ≥25 in our research volunteer database

● 2,039 volunteers with a BMI ≥36 in our research volunteer database

Specialized Equipment and Staff:

● 2 Board-certified endocrinologist investigators

● 4 Registered dietitians

● Digital and Manual Scales

● Bariatric seating available

Historical Statistics

Condition	# of Subjects Screened	Enrollment Goal	Number Enrolled	% of Goal Met
Dyslipidemia / Obesity	22	12	15	125%
Hypertension / Obesity / Diabetes	25	8	13	163%
Obesity	26	10	17	170%
Cardio/Obesity	25	10	10	100%
Obesity	75	25	75	300%

Total number of previous Osteoarthritis studies:

● 71 Osteoarthritis clinical trials

Patient Population:

● Over 5,136 volunteers with osteoarthritis in our research volunteer database

Specialized Equipment and Staff:

● Dr. Ervin is board-certified in internal medicine and rheumatology

● 2 Board-certified rheumatologist sub-investigators

● On-site DEXA machine

● On-site X-ray

● Fluroscopy and Ultrasound available for injections

● MRI and other diagnostic procedures available through our affiliates

Historical Statistics

Length of Enrollment	Enrollment Goal	Number of Subjects Screened	Actual Enrollment	% of Enrollment Goal
5 months	10	100	62	620%
6 months	12	42	28	233%
7 months	12	78	68	567%
20 months	15	49	37	247%
3 months	10	23	20	200%
7 months	10	48	32	320%
3 months	10	44	41	410%
4 months	7	19	16	229%
3.5 months	12	35	28	233%
6 months	10	62	51	510%
2.5 months	10	43	40	400%
3 months	10	50	27	270%

Total number of previous Osteoporosis studies:

● 7 Osteoporosis studies

Patient Population:

● 1,113 volunteers with osteoporosis in our research volunteer database

Specialized Equipment and Staff

● The Center for Pharmaceutical Research provides all diagnostic equipment necessary for osteoporosis studies. Our facility includes:

• On-site DEXA

• On-site X-Ray

• MRI and other diagnostic procedures are available through our affiliates

● Dr. Ervin is board-certified in internal medicine and rheumatology

● 2 additional sub-investigators board-certified in internal medicine and rheumatology

Total number of previous allergy/asthma studies:

● 1 Pediatric flu vaccine study

● 2 Infant meningitis vaccine studies

● 2 Adolescent meningitis B vaccine studies

● 1 DTap/IPV vaccine study

● 1 ADHD study

● 2 Infant formula studies

● 1 Timothy grass allergy study

● 1 Dust mite allergy study

● 1 Cat allergy study

● 2 Asthma studies

Patient Population:

● 28,000 Patients in pediatric private practice database

● 5,000 patients pediatric allergy practice database

● 2,197 pediatric patients in our research volunteer database

Specialized Equipment and Staff:

● 3 Board-certified pediatrician investigators

● 2 Pediatric nurse practitioner investigators

● 1 Pediatric allergist investigator

Historical Statistics

Condition	Age Range	Length of Enrollment	Sponsor’s Enrollment Goal	Number of Subjects Screened	Number Actually Enrolled	% of Enrollment Goal
Pediatric Flu Vaccine	2 to 18	1.5 months	20	43	41	205%
ADHD	6 to 17	1 months	12	21	13	108%
Pediatric Meningitis Vaccine	2 months	2 months	4	3	3	75%
Meningitis B Vaccine	10 to 13	6 months	30	90	89	297%
Meningitis B Vaccine	11 to 17	ongoing	30	18 current, enrollment ongoing	18 current, enrollment ongoing	ongoing
Infant Formula	14 days or less	ongoing	8	9 current, enrollment ongoing	9 current, enrollment ongoing	ongoing
Timothy Grass Allergy	5+	3.5 months	8	17	5	71%
Asthma	4 to 11	ongoing	8	10 current, enrollment ongoing	7 current, enrollment ongoing	ongoing
Asthma	12+	ongoing	8	8 current, enrollment ongoing	8 current, enrollment ongoing	ongoing
Infant Formula	17 days	ongoing	9	ongoing	ongoing	ongoing
DTaP/IPV Vaccine	4 to 6	ongoing	50	46 current, enrollment ongoing	45 current, enrollment ongoing	ongoing
Meningitis Vaccine	9 - 18 months	ongoing	20	9 current, enrollment ongoing	9 current, enrollment ongoing	ongoing

Total number of previous Post-Herpetic Neuralgia studies:

● 10 Post-herpetic neuralgia studies

Patient Population:

● 450 volunteers with PHN in our research volunteer database

Specialized Equipment and Staff:

● Board-certified neurologist investigator

Historical Statistics

Condition	Enrollment Goal	Recruitment Total	Enrollment Total	% of Enrollment Goal Met
PHN	10	15	11	110.00%
PHN	None	8	6	No Goal
PHN	4	25	9	225.00%
PHN	6	23	16	267%

Total number of previous allergy/asthma studies:

● 36 Rheumatoid arthritis studies

Patient Population:

● 977 volunteers with rheumatoid arthritis in our research volunteer database

Specialized Equipment and Staff:

● Dr. Ervin is board-certified in rheumatology

● 2 additional board-certified rheumatologists

Historical Statistics

Condition	Length of Enrollment	Number of Subjects Screened	Sponsor's Enrollment Goal	Number Actually Enrolled	% of Enrollment Goal
RA	11 months	13	5	10	200.00%
RA	9 months	11	5	7	140.00%
RA/OA	7 months	78	12	68	566.67%
RA/OA	unk	?	6	7	116.67%
RA/OA	2.5 months	43	10	40	400.00%
RA	unk	14	No Goal	13	No Goal
RA	unk	34	15	30	200.00%

Total number of previous Sleep Disorder studies:

● 14 Insomnia studies

Patient Population:

● 5,710 patients with insomnia in our databases

Specialized Equipment and Staff:

● AASM accredited sleep lab

● Our staff is experienced in the use of the following insomnia assessment tools, among others:

Insomnia Severity Index	Tyrer Questionnaire
Hospital Anxiety and Depression Scale	Patient Global Impression
MINI Mental State Examination	Beck Depression Scale
Functional Outcomes of Sleep Questionnaire	Sleep Diaries (Paper, Electronic, and IVRS)
Sheehan Disability Scale	Profile of Mood States
Health Economics Assessment

Historical Statistics

Condition	Length of Enrollment	Sponsor's Enrollment Goal	Number of Subjects Screened	Number Actually Enrolled	% of Enrollment Goal
Elderly Insomnia	5 months	8	19	7	88%
Elderly Insomnia	7 months	10	24	16	160%
Elderly Insomnia	5 months	10	10	10	100%
Insomnia	14 months	10	26	8	80%
Insomnia	13 months	10	46	33	330%
Insomnia	3 months	12	25	18	150%
Insomnia	3 months	10	16	15	150%

Total number of previous Smoking Cessation studies:

● 6 Smoking cessation studies

• 5 Studies involving tobacco products

• 2 Studies using nicotine replacement therapies

Patient Population:

● Over 11,872 patients in our databases who currently smoke

Specialized Equipment and Staff

● 3 board-certified pulmonologist sub-investigators

● 1 board-certified psychiatrist sub-investigator

● 1 psychologist sub-investigator

● Experienced Tobacco Dependency and Cessation counselors

● 4 registered dieticians

Missouri Smoking Statistics:

Smoking continues to be a major health concern in Missouri, as Missouri’s smoking rates remain high above the national average. According to a 2010 report for the Centers for Disease Control and Prevention, * Missouri has the fourth highest smoking rate in the nation.

● Over 25% (1,120,000 people) of adults in Missouri smoke.

• The national median is 18.4%

● 11.8% of Missouri adolescents ages 12-17 smoke.

• The national average is 10.1%

● 24.6% of Kansas City residents smoke (418,200 people)

● Nearly 50% of Kansas City smokers have tried to quit smoking in the past.

Total number of previous Urology studies:

● 5 Erectile Dysfunction

● 8 Premature Ejaculation

● 8 Benign Prostatic Hyperplasia

● 3 Urinary Tract Infections

● 4 Overactive Bladder

● 1 Stress Urinary Incontinence

● 1 Semen Analysis

Research Database Patient Population:

● 525 volunteers with erectile dysfunction

● 473 volunteers with premature ejaculation

● 709 volunteers with benign prostatic hyperplasia

● 340 volunteers with history of UTI

● 528 volunteers with overactive bladder

● 179 volunteers with stress urinary incontinence

Specialized Equipment and Staff

● Board-certified urologist investigators in our building

● Coordinator with 13 years of experience in urology studies

● Work with local, specialized lab for semen analysis tests

● Bladder scanner for post-void residual measurements available on-site

The Center for Pharmaceutical Research (CPR) has conducted 32 vaccine studies including 15 flu, 2 swine flu, 3 avian flu, 2 herpes zoster, 3 pneumonia, 2 DTP, 1 botulism/bio-terrorism, 2 hepatitis B, 1 pediatric flu, and 1 pediatric meningitis. Our site is a consistent topenroller, usually randomizing 60-80 volunteers per day and completing enrollment in less than 3 days. CPR averages 107 randomized subjects per vaccine study, and has enrolled as many as 313 in a single study.

Since 2005, CPR has enrolled over 2,938 total volunteers in vaccine clinical trials. For most studies, all patients are recruited from our patient database with no advertising. Please see enrollment statistics from previous studies below.

Historical Statistics

Indication	Enrollment Time	Enrollment Length	Actual Enrollment	Enrollment Goal	% of Enrollment Goal Met
Flu Vaccine	1	month	153	90	170%
DTP Vaccine Study	0.50	month	37	50	100.%
Flu Vaccine	3	months	291	200	145%
Pneumonia Vaccine	1	month	99	40	247%
Herpes Zoster Vaccine	8	months	313	240	130%
Flu Vaccine	0.25	month	89	48	185%
Flu Vaccine	0.50	month	128	75	170%
Flu Vaccine	0.10	month	130	75	173%
Pneumonia Vaccine	3.50	months	52	48	108%
Avian Flu Vaccine (H5N1)	0.75	month	70	70	100%
Avian Flu Vaccine (H5N1)	0.10	month	81	63	129%
Flu Vaccine	0.06	month	80	80	100%
Botulism Vaccine	5	months	92	70	131%
Flu Vaccine	1	month	139	100	139%
Flu Vaccine	0.50	month	151	121	124%
Flu Vaccine	0.25	month	38	No Goal	100.00%
Flu Vaccine	0.50	month	91	107	85%
Flu Vaccine	0.50	month	163	144	113%
Herpes Zoster Vaccine	0.75	month	83	27	307%
Flu Vaccine (Nasal)	0.13	month	100	100	100%
Flu Vaccine	0.07	month	75	75	100%
DTP Vaccine Study	1.50	months	26	No Goal	100%
Swine Flu (H1N1) Vaccine	0.06	month	60	60	100%
Flu Vaccine	0.07	month	43	No Goal	100%
Avian Flu Vaccine (H5N1)	10	month	91	16	569%
Swine Flu (H1N1) Vaccine	0.75	month	115	100	115%
Pediatric Meningitis Vaccine	2	months	3	4	75%
Hepatitis B Vaccine in pts with CKD	11	months	20	16	125%
Pneumonia Vaccine	1.50	months	42	42	100%
Pediatric Flu Vaccine	1.50	months	41	20	205%
Hepatitis B Vaccine in healthy volunteers	0.13	month	68	50	136%
Flu Vaccine	0.75	month	39	39	100%
Plague Vaccine	1.25	months	37	36	103%
Herpes Zoster Vaccine	10	months	36	39	92%
Avian Flu Vaccine (H5N1)	0.75	month	15	15	100%
Herpes Zoster Vaccine	9	months	29	28	103%
Flu Vaccine (Universal)	0.50	month	16	16	100%
C. Difficile			7	7	100%
Flu Vaccine	0.50	month	180	145	124%
Avian Flu Vaccine (H5N1)	2	months	50	50	100%
Meningitis Vaccine	7	months	89	30	297%

Total number of previous Women’s Health studies:

● 5 Low libido/HSDD/FSD

● 2 Genital herpes

● 1 Stress urinary incontinence

● 4 Overactive bladder

● 3 Urinary tract infection

● 1 Hormone replacement therapy

● 6 Osteoporosis

● 5 Birth Control

● 2 Heavy menstrual bleeding

● 1 Hot flash

● 1 Menstrual migraine

Research Database Patient Population:

● 297 volunteers with low libido

● 84 volunteers with genital herpes

● 146 volunteers with stress urinary incontinence

● 379 volunteers with overactive bladder

● 283 volunteers with history of urinary tract infection

● 991 volunteers with osteoporosis

● 182 volunteers with heavy menstrual bleeding

● 324 volunteers with hot flashes

● 1,729 volunteers with migraines

Specialized Equipment and Staff

Our staff includes several OB-GYN sub-investigators and a coordinator with over 31 years of women’s health experience. The Center for Pharmaceutical Research routinely conducts the following tests and women’s health assessment tools and tests, among others:

● PAP and Pelvic

● Colposcopy

● Endometrial Biopsy

● Ultrasound, pelvic and vaginal

● Female Sexual Distress Scale

● Female Sexual Functioning

● Sexual Interest & Desire Inventory

● Vasomotor symptom Questionnaire

● Beck’s Depression Inventory

● Patient Global Impression

● Evaluation of Virilization

● Quality of Life Questionnaires