Studies

ClinDatrix Project Experience

Service Codes
BI = Biostatistics
CL = Clinical
DM = Data Management
FS = Full Service
MS = Medical Safety
MW = Medical Writing
RA = Regulatory Affairs

Phase	Indication	Therapeutic Area	Services	Number of Sites	Number of patients
1	Metastatic Cancer	Oncology	FS	1	21
1	KRAS Mutant Metastatic Colorectal Cancer	Oncology	BI, DM	3	25
1	KRAS Mutant Metastatic Colorectal Cancer	Oncology	BI, DM	3	36
1	Autoimmune	Endocrinology	BI, DM	1	46
1	Advanced Solid Tumors	Oncology	DM	3	27
1	Chronic Lymphocytic Leukemia	Oncology	BI, DM	5	10
1	Herpes Zoster	Infectious Diseases	DM	5	700
1	Extensive, recurrent or metastatic sarcoma, melanoma, or carcinoma	Oncology	CL, RA	20	96
1	Prevention of MI and Stroke	Cardiovascular	FS	1	18
1	Infectious Disease	Infectious Disease	FS	1	8
1	Depression	CNS	CL	1	160
1	Motion Sickness	CNS	CL	1	150
1	Severe Combined Immunodeficiency	Rare Diseases	MS	1	42
2	Plaque Psoriasis	Dermatology	BI, DM, MS, MW	5	60
2	Diabetic Macular Edema	Ophthalmology	BI, CL, DM, MW	8	40
2	Glioblastoma and Gliosarcoma	Oncology	DM, CL	1	25
2	HIV Cardiovascular Risk Resuction	Cardiovascular	CL, DM, MW	1	64
2	Meibomian Gland Dysfunction Associated Dry Eye Disease	Ophthalmology	BI, CL, DM, MW	5	90
2	Advanced Pancreatic Adenocarcinoma	Oncology	DM	2	34
2	Metastatic Melanoma	Oncology	DM	1	14
2	Squamous Cell Cacinoma of the Lung	Oncology	DM	12	32
2	Dry Eye	Ophthalmology	BI, DM	2	62
2	Hereditary Angioedema	Endocrinology	CL	15	30
2	PET Study	CNS	FS	1	20
2	Bipolar Depression	CNS	FS	1	108
2	Motion Sickness in Hepatically Impaired Patients	CNS	CL	1	24
2	Motion Sickness in Renally Impaired Patients	CNS	FS	1	8
2	Motion Sickness on Commercial Boat	CNS	FS	1	300
2	Plaque Psoriasis	Dermatology	BI, DM, MS, MW	4	69
2	Atopic Dermatitis	Dermatology	BI, CL, DM, MW	1	72
3	Squamous Cell Carcinoma of the Head and Neck	Oncology	BI, CL, DM	58	184
3	Squamous Cell Carcinoma of the Head and Neck	Oncology	BI, MW	58	184
3	Motion Sickness	CNS	FS	1	60
3	Motion Sickness on Commercial Boat and at 3 CNS Sites	CNS	FS	1	102
3	Motion Sickness on Commercial Boat and at 3 CNS Sites (Elderly Population)	CNS	FS	1	100
1/2	Open-angle Glaucoma or Ocular Hypertension	Ophthalmology	BI, CL, DM, MS, MW	1	50 (18)
1/2A	Recurrent Grade IV Glioma	Oncology	FS	9	49
1B	Malignant Pleural Mesothelioma	Oncology	BI, CL, DM	5	60
2A	Molluscum Contagiosum in Pediatric Subjects	Dermatology	BI, DM, MS	1	60
Device	Knee Replacement	Musculoskeletal	CL	6	260
Device Ceasibility Study	Vision Improvement	Ophthalmology	FS	22	396
Device Crossover Study	Vision Improvement	Ophthalmology	FS	11	198
For Approval	Astigmatism Soft Contact Lenses when worn on a daily basis	Ophthalmology	FS	2	120
1	Diabetes	Endocrinology	BI, DM	1	22
1	Healthy Volunteers	Endocrinology	BI, DM	1	14
1	Solid Tumors	Oncology	BI, DM	5	27
1	Advanced Solid Tumors or Lymphoma	Oncology	BI, DM	3	107
1	Lymphocytic Leukemia	Oncology	BI, DM	1	8
1	Lymphocytic Leukemia	Oncology	BI, DM	1	12
1	Lymphocytic Leukemia	Oncology	BI, DM	1	2
1	Metastatic Solid Tumors	Oncology	BI, DM	1	18
1	Advanced Malignancies	Oncology	BI, DM	2	17
1	Advanced Malignancies	Oncology	BI, DM	3	25
1	Advanced Malignancies	Oncology	BI, DM	3	38
1	Oncology	Oncology	BI, CL, DM	1	5
1	Chronic Lymphocytic Leukemia	Oncology	BI, DM	3	15
1	Diabetic Macular Edema	Ophthalmology	BI, CL, DM	6	22
1	Age-Related Macular Degeneration	Ophthalmology	DM	8	56
1/2	Malignant Gliomas	Oncology	BI, DM	3	18
1/2	Advanced Malignancies	Oncology	BI, DM	2	34
1/2	Oncology	Oncology	BI	4	20
1/2A	Basal Cell Carcinoma	Oncology	FS	3	27
1/2A	Scar Formation and Keloid Recurrence Following Surgical Keloidectomy	Dermatology	FS	5	30
1A/1B	Advanced Metastatic Solid Tumors and NSCLC	Oncology	BI, DM, MS, MW	7	84
1A/1B	Recurrent Head and Neck Cancer	Oncology	BI, CL, DM, MS, MW	7	40
IDE	Bifurcated Stent Graft Study with a 5-Year Follow-up	Cardiovascular	BI, DM	15	64
IDE	Endovascular Aneurysms	Cardiovascular	BI, DM	2	15
IDE	Endovascular Aneurysms	Cardiovascular	BI, DM	8	34
IDE	Endovascular Aneurysms	Cardiovascular	BI, DM	20	96
IDE	Abdominal Aortic Aneurysms	Cardiovascular	DM	3	15
IDE	Endovascular Aneurysms	Cardiovascular	DM	20	192
2	Atopic Dermatitis	Dermatology	BI, DM, MS, MW	5	71
2	Sickle-Cell Anemia, Sickle Beta-Thalassemia	Hematology	BI, CL, DM	5	80
2	Sickle-Cell Anemia – Exercise Study	Hematology	BI, CL, DM	1	15
2	Advanced Cancers including Head, Neck, and Esophageal Cancers	Oncology	BI, DM	3	16
2	Bone and Soft Tissue Sarcomas Metastatic to the Lung	Oncology	BI, DM	4	53
2	Squamous Cell Carcinoma of the Head and Neck	Oncology	BI, DM	2	14
2	Non-Small Cell Lung Cancer accompanied by KRAS or EGFR Activated Tumors	Oncology	BI, DM	2	37
2	Coronary Artery Disease	Cardiovascular	DM	15	200
2	Plaque Psoriasis	Dermatology	DM	12	260
2	Atopic Dermatitis	Dermatology	BI, DM, MS, MW	5	72
2	Diabetic Gastroparesis	Endocrinology	DM	6	89
3	Sickle-Cell Anemia, Sickle Beta-Thalassemia	Hematology	FS	31	230
3	Motion Sickness	CNS	BI, CL, DM, MW	1	360
3	Motion Sickness	CNS	BI, CL, DM, MW	1	30
3	Motion Sickness	CNS	FS	1	54
IND	Treatment-Resistant Major Depressive Disorder	CNS	RA	1	72
4	Vitreomacular Adhesion	Ophthalmology	BI, CL, DM	22	134
N/A	Dry AMD	Ophthalmology	DM, MS	2	15
N/A	Oncology	Oncology	BI, DM	1	19
N/A	Oncology	Oncology	BI, DM	1	19
N/A	Oncology	Oncology	BI, DM	2	33
N/A	Oncology	Oncology	BI, DM	2	25
N/A	Oncology	Oncology	BI, DM	1	6
N/A	Oncology	Oncology	BI, DM	1	12
N/A	Transmyocardial Revascularization	Cardiovascular	BI, DM	6	81
N/A	Facial Acne Vulgaris	Dermatology	DM	1	266
N/A	Hematologic Malignancies	Hematology	DM	4	90
Pilot Study	Autism	CNS	CL	1	20
PMA	Soft Contact Lenses worn on a 7-Day Extended Wear	Ophthalmology	FS	34	818
Proof of Concept	Blood Loss Monitoring	Cardiovascular	CL, MS, RA	1	20
Proof of Concept	Blood Loss Monitoring	Cardiovascular	CL, MS, RA	1	20
TBD	Prostate Cancer	Oncology	CL	1	167
TBD	Renal Transplant Recipients	Urology	CL	6	200