Clinical Operations | Data Management | Medical Writing | Auditing Services | Feasibility Data






CLINICAL OPERATIONS

COMPLETED PROJECTS
Therapeutic Area	Sites	Patients	Sponsor	Study Phase
Immunology - BA / BE	1	24	US MNC	Phase I
Immunology - BA / BE	1	24	US MNC	Phase I
Immunology - BA / BE	1	24	US MNC	Phase I
Immunology - BA / BE	1	24	European MNC	Phase I
Malaria	3	200	European MNC	Phase II
Cardiovascular	11	250	Indian MNC	Phase III
Glaucoma	5	120	US MNC	Phase III
Asthma	14	280	Indian MNC	Phase III
Chronic Renal Failure	9	140	Korean MNC	Phase IIIb
Fungal infections Survey	10	250	US MNC	Phase IV
Malaria Diagnostic Kit	1	143	US MNC	Diagnostic
ONGOING PROJECTS
Therapeutic Area	Sites	Patients	Sponsor	Study Phase	Study Status
Oncology - Colorectal Cancer	5	25	European MNC	Phase IIIb	Site Close Outs Phase
Oncology - NSCLC	5	25	European MNC	Phase IIIb	Site Close Outs Phase
Neuropsychiatry	3	30	UK MNC	Phase III	Site Close Outs Phase
Oncology - Lymphoma	3	15	European MNC	Phase III	Follow Up Phase
Immunology - Vaccine	1	60	Canadian MNC	Phase I	Follow Up Phase
Neuropsychiatry	8	80	UK MNC	Phase II	Site Close Outs Phase
Immunology - BA / BE	1	24	US MNC	Phase I	Follow Up Phase
Immunology - BA / BE	1	24	US MNC	Phase I	Follow Up Phase
Oncology - AML	10	120	UK MNC	Phase II	Regulatory Filing
Cardiovascular	25	375	European MNC	Phase II	Regulatory Filing
Oncology - Breast Cancer.	5	40	US MNC	Phase II	Regulatory Filing
OBGY - Short Cervix	5	150	US MNC	Phase III	Regulatory Filing
Neurology - Parkinson's	4	14	US MNC	Phase II	Regulatory Filing
Urology - Cystitis	15	350	Canadian MNC	Phase III	Site Selection

DATA MANAGEMENT

COMPLETED PROJECTS
Therapeutic Area	Pages	Patients	Sponsor
Glaucoma	8,040	120	US MNC
Diabetes Mellitus- Type 2	2,600	64	European MNC
Diabetes Mellitus- Type 2	2,600	64	European MNC
Fungal infections	3,300	165	US MNC
Cardiovascular	400	100	US MNC
Cardiovascular	336	48	US MNC
Atopic Dermatitis	2,200	60	European MNC
Ambient Music Therapy	13,475	245	US MNC
Cardiovascular	8,700	300	Indian
Diabetes Mellitus- Type 2	5,000	120	European MNC
ONGOING PROJECTS
Therapeutic Area	Pages	Patients	Sponsor
Diabetes Mellitus	26,780	2060	US MNC
Myocardial Infarction (EDC)	2,320	40	US MNC
Psoriasis	12,136	328	European MNC
Urology-Interstitial cystitis	14,000	350	Canadian MNC
Cardiovascular	2,880	288	US MNC

Medical Writing

COMPLETED PROJECTS
Therapeutic Area	Sponsor
Atopic Dermatitis	European MNC
Glaucoma	US MNC
Diabetes Mellitus- Type 2	European MNC
Diabetes Mellitus- Type 2	European MNC
PROJECTS AWARDED
Therapeutic Area	Sponsor
Atopic Dermatitis	European MNC
Cardiovascular	US MNC
Cardiovascular	Indian MNC
Abdominal Surgery	US MNC

Auditing services

COMPLETED PROJECTS
Therapeutic Area	Sponsor
Site Audits	Indian MNC (European Submission)
Process Audit	Indian MNC
Process Audit	Ethics Committee
PROJECTS AWARDED
Site Audits	5 sites for Indian MNC (European Submission)

FEASIBILITY DATA

Clinical Operations
ONCOLOGY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Bladder Cancer	12	1
2	Pancreatic Cancer	5	2
3	Breast Cancer	6	1 – 2
4	Untreated Breast Cancer	6	0.5
5	Acute Myelogenous Leukemia (2 studies)	6	0.33
6	Metastatic Soft Tissue Sarcoma	4	0.5
7	Non-Hodgkin’s Lymphoma	3	1
8	Non-small Cell Lung Cancer	5	1 – 2
9	Advanced Renal Cell Cancer	11	2
10	Cervical Cancer	5	6 – 7
11	Cancer Pain	6	3
Neurology – PSYCHIATRY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Parkinson’s Disease	10	2 – 3
2	Parkinsonian Syndrome	10	6 – 8
3	Bipolar Disorder	4	2 – 3
4	Bipolar 1 Disorder	4	2 – 3
5	Acute Mania in Bipolar Disorder	10	1 – 2
6	Mania	18	4 – 7
7	Alzheimer’s Disease (2 Studies)	10	2 – 3
8	Schizophrenia	16	4 – 5
9	Depression	17	5 – 10
10	Anxiety	18	5 – 10
11	Multiple Sclerosis	3	0.5 – 1
12	Post Herpetic Neuralgia	5	4
13	Cerebrovascular Accident	5	8
DIABETES
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	T2DM (Anti-diabetic Monotherapy)	11	6 – 8
2	T2DM (Drug Naοve Patient)	15	5 – 7
3	T2DM (Placebo Controlled Trial) (2 Studies)	14	4 – 5
4	T2DM (Inadequately controlled on Diet)	14	6 – 7
5	T2DM (Inadequate glycemic control on metformin therapy)	6	4
6	T2DM (Human Recombinant Insulin)	6	7 – 8
RESPIRATORY SYSTEM
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Respiratory Tract Infection	10	4
2	Tuberculosis	10	10 – 20
3	COPD	5	2 – 3
4	Adult Asthma	15	4 – 5
5	Pediatric Asthma	10	1
6	Pediatric Asthma (IV IMP)	20	3
7	Pediatric Cough	19	8 – 10
CARDIOVASCULAR SYSTEM
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Cardiogenic Shock	10	5 – 6
2	Stable Angina	6	1
3	Hypertension	10	10
4	Coronary Artery Disease	4	6
5	Dyslipidemia	4	5
6	Hypo Alpha Lipo-proteinemia	6	3 – 4
GASTROENTROLOGY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Diarrhea	10	8
2	Variceal Bleeding	4	3 – 4
3	Ulcerative Colitis 1 (naοve)	10	1-Feb
4	Ulcerative Colitis 2 (remission)	10	3 – 4
5	Hepatitis B	10	2 – 4
6	Hepatitis C	10	2
7	Esophageal Candidiasis	2	5 – 6
8	Hemorrhoids	10	2 – 3
NEPHROLOGY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Chronic Renal Failure	9	2 – 3
2	Overactive Bladder	2	6
IMMUNOLOGY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	DT Vaccine	5	10-Aug
2	DPT Vaccine	5	15 - 20
3	Hepatitis B Vaccine	3	8 – 10
4	Hepatitis C Vaccine	3	8 – 10
5	AIDS	10	7 – 10
6	Systemic Lupus Erythematosus	6	2
7	Rheumatoid Arthritis	10	5 – 10
OPHTHALMOLOGY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Glaucoma (2 Studies)	4	4 – 5
2	Seasonal Allergic Conjunctivitis	6	4 – 5
3	Wet Age related Macular Disease	4	1
4	Cataract	4	4 – 5
ORTHOPEDICS
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Fracture Healing	4	7 – 8
2	Osteoarthritis	5	5 – 6
3	Lower Back Pain	3	6 – 10
4	Post Menopausal Osteoporosis	7	10-Aug
OTORHINOLARYNGOLOGY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Allergic Rhinitis	8	4 – 5
2	Otomycosis	10	20
DERMATOLOGY
Sl. No.	Indication	No. of feasibility sites	Recruitment rate/ site/month
1	Scabies	3	6 – 7
2	Dandruff / Seborrheic Dermatitis	8	6 – 7
3	Burn (1st and 2nd Degree)	4	5 – 6
4	Psoriasis	10	3 – 4
5	Onychomycosis	10	10
6	Impetigo	2	15
7	Acne Vulgaris	4	12