Carman Research

Jan 27, 20101 like1,057 views

Carman Research is an experienced clinical research organization with physicians who have decades of experience in clinical trials. They have a dedicated team that has worked there for many years. Carman Research has extensive experience conducting clinical trials across many therapeutic areas, phases of development, and indications. They have consistently high enrollment and retention rates. Data quality is ensured through physician involvement and electronic data capture. Carman Research has contributed to the approval of numerous pharmaceutical products through pivotal clinical trials over 28 years.

Experienced Physicians
John S. Carman, M.D.
Medical Director and Founder of Carman Research
Clinical research for over 38 years
Clinical trial investigator for over 300 clinical trials
Board certified in psychiatry
Well published with previous NIMH and
academic experience (University of Alabama)

Nathan Andrew Shapira, M.D., Ph.D.
Clinical research for over 12 years
Board certified in psychiatry; Ph.D. in neuropathology
Well published with previous industry (Solvay
Pharmaceuticals and Tikvah Therapeutics) and
academic experience (University of Florida)

Dedicated and Stable Team
Edwinia Paden-Johnson
Medical Records Coordinator
With Carman Research for 26 years
Casey Chacona
Senior Research Coordinator
With Carman Research for 10 years
Becky Empric and Robin Swinks
Research Coordinators
With Carman Research for 7 and 3 years, respectively
Marc McLaughlin and Lori Johnson
Office Administration and Recruitment
With Carman Research for 3 years

Broad Experience
Therapeutic Area Number of Studies (by 2009)
Major Depressive Disorder 139 (including 4 TRD)
Schizophrenia/Schizoaffective Disorder 44
Generalized Anxiety Disorder 37
Bipolar Disorder 27 (Mania); 15 (Dep); 4 (Proph)
Alzheimer’s Disorder 11
Panic Disorder 6
Insomnia 5
Social Anxiety Disorder 3
Obsessive-Compulsive Disorder 3
Adult Attention Deficit Disorder 3
Chronic Pain and Fibromyalgia 3
Obesity 1

Clinical Trial Phase Experience
Phase of Development Number (by 2009)
Phase Ib/IIa 10
Phase II 112
Phase III 140
Phase IV 39

Excellent Enrollment
Indication Screened Randomized
Major Depressive Disorder 35 30
Major Depressive Disorder 19 15
Major Depressive Disorder 22 16
Major Depressive Disorder 36 25
Major Depressive Disorder (ext) 15 10
Major Depressive Disorder 56 36
Generalized Anxiety Disorder 12 11
Generalized Anxiety Disorder 22 21
Generalized Anxiety Disorder 13 12
Generalized Anxiety Disorder 26 22
Bipolar Disorder, Depression 14 12
Overall for 2008-2009 (18 months) 270 210 (78%)

Excellent Retention
Indication Randomized Completed
(> 8 weeks)
Major Depressive Disorder 30 25
Major Depressive Disorder 15 12
Major Depressive Disorder 16 9
Major Depressive Disorder 25 17
Major Depressive Disorder (ext) 10 6
Major Depressive Disorder 36 35
Generalized Anxiety Disorder 11 9
Generalized Anxiety Disorder 21 18
Generalized Anxiety Disorder 8 7
Generalized Anxiety Disorder 22 18
Bipolar Disorder, Depression 12 9
Overall for 2008-2009 (18 months) 210 165 (80%)

Quality Data
Physicians integrally involved in every visit and
administer rating scales
Very low rate of rater switching during study
Electronic data capture entered efficiently
Low placebo response rates:
24% for Major Depressive Disorder (5 studies)
30% for Generalized Anxiety Disorder (3 studies)
For studies over the past 4 years, with greater
than 10 per arm and code breaks available
High compliance:
In a recent phase II GAD trial with pharmacokinetic
Levels, our subjects demonstrated the highest
Percent confirmed compliance with study
medication.

Proven Results
In its 28 years of existence in Northwest Atlanta,
Carman Research has conducted clinical studies
for more than 60 sponsoring pharmaceutical
companies. Carman Research has been involved in
pivotal studies leading to approval and/or expansion
of indications for 23 psychoactive compounds now
on the market, for over 30 different formulations
or indications:
Abilify Geodon Saphris
Aricept Invega Seroquel (IR and XR)
Celexa Lexapro Wellbutrin (IR,SR and XL)
Depakote Namenda Xanax XR
Desyrel (IR and Paxil (IR and CR) Zoloft
Contramid) Pristiq Zyprexa
Effexor (IR and XR) Prozac
Emsam Remeron
Exelon Risperdal

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Carman Research

2. Experienced Physicians John S. Carman, M.D. Medical Director and Founder of Carman Research Clinical research for over 38 years Clinical trial investigator for over 300 clinical trials Board certified in psychiatry Well published with previous NIMH and academic experience (University of Alabama) Nathan Andrew Shapira, M.D., Ph.D. Clinical research for over 12 years Board certified in psychiatry; Ph.D. in neuropathology Well published with previous industry (Solvay Pharmaceuticals and Tikvah Therapeutics) and academic experience (University of Florida)

3. Dedicated and Stable Team Edwinia Paden-Johnson Medical Records Coordinator With Carman Research for 26 years Casey Chacona Senior Research Coordinator With Carman Research for 10 years Becky Empric and Robin Swinks Research Coordinators With Carman Research for 7 and 3 years, respectively Marc McLaughlin and Lori Johnson Office Administration and Recruitment With Carman Research for 3 years

4. Broad Experience Therapeutic Area Number of Studies (by 2009) Major Depressive Disorder 139 (including 4 TRD) Schizophrenia/Schizoaffective Disorder 44 Generalized Anxiety Disorder 37 Bipolar Disorder 27 (Mania); 15 (Dep); 4 (Proph) Alzheimer’s Disorder 11 Panic Disorder 6 Insomnia 5 Social Anxiety Disorder 3 Obsessive-Compulsive Disorder 3 Adult Attention Deficit Disorder 3 Chronic Pain and Fibromyalgia 3 Obesity 1

5. Clinical Trial Phase Experience Phase of Development Number (by 2009) Phase Ib/IIa 10 Phase II 112 Phase III 140 Phase IV 39

6. Excellent Enrollment Indication Screened Randomized Major Depressive Disorder 35 30 Major Depressive Disorder 19 15 Major Depressive Disorder 22 16 Major Depressive Disorder 36 25 Major Depressive Disorder (ext) 15 10 Major Depressive Disorder 56 36 Generalized Anxiety Disorder 12 11 Generalized Anxiety Disorder 22 21 Generalized Anxiety Disorder 13 12 Generalized Anxiety Disorder 26 22 Bipolar Disorder, Depression 14 12 Overall for 2008-2009 (18 months) 270 210 (78%)

7. Excellent Retention Indication Randomized Completed (> 8 weeks) Major Depressive Disorder 30 25 Major Depressive Disorder 15 12 Major Depressive Disorder 16 9 Major Depressive Disorder 25 17 Major Depressive Disorder (ext) 10 6 Major Depressive Disorder 36 35 Generalized Anxiety Disorder 11 9 Generalized Anxiety Disorder 21 18 Generalized Anxiety Disorder 8 7 Generalized Anxiety Disorder 22 18 Bipolar Disorder, Depression 12 9 Overall for 2008-2009 (18 months) 210 165 (80%)

8. Quality Data Physicians integrally involved in every visit and administer rating scales Very low rate of rater switching during study Electronic data capture entered efficiently Low placebo response rates: 24% for Major Depressive Disorder (5 studies) 30% for Generalized Anxiety Disorder (3 studies) For studies over the past 4 years, with greater than 10 per arm and code breaks available High compliance: In a recent phase II GAD trial with pharmacokinetic Levels, our subjects demonstrated the highest Percent confirmed compliance with study medication.

9. Proven Results In its 28 years of existence in Northwest Atlanta, Carman Research has conducted clinical studies for more than 60 sponsoring pharmaceutical companies. Carman Research has been involved in pivotal studies leading to approval and/or expansion of indications for 23 psychoactive compounds now on the market, for over 30 different formulations or indications: Abilify Geodon Saphris Aricept Invega Seroquel (IR and XR) Celexa Lexapro Wellbutrin (IR,SR and XL) Depakote Namenda Xanax XR Desyrel (IR and Paxil (IR and CR) Zoloft Contramid) Pristiq Zyprexa Effexor (IR and XR) Prozac Emsam Remeron Exelon Risperdal

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Carman Research

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