SUMMARY OF CRA EXPERIENCE
overview
¨ Average of 15 years (range: 8 – 21 years) field monitoring experience
¨ Extensive training and experience resulting from prior monitoring and management roles at pharmaceutical, biotechnology, medical device, diagnostics, and/or clinical research organizations
¨ Established, reliable consultants with a strong commitment to quality
¨ Several of our consultants also have backgrounds as:
– Clinical research managers and/or coordinators in a healthcare setting
– Good clinical practices (GCP) auditors
service capabilities
¨ Study site monitoring (pre-study evaluation, study initiation, treatment observation, routine monitoring, study close-out)
¨ Study coordinator support (CRF/DRF completion, document management)
¨ Study site GCP auditing
therapeutic area/indication experience
CARDIOVASCULAR / CNS/NEUROLOGY· Angina / · Generalized Anxiety Disorder
· Anticoagulant Therapy / · Alzheimer’s Disease
· Arrhythmia Control / · Attention Deficit Hyperactivity Disorder
· Arterial Stenosis / · Bipolar Disorder
· Atrial Fibrillation / · Depression
· Cardiac Stents / · Epilepsy
· Congestive Heart Failure / · Migraine
· Coronary Artery Disease / · Obsessive Compulsive Disorder
· Hypercholesterolemia / · Panic Disorder
· Hyperlipidemia / · Parkinson’s Disease
· Deep Vein Thrombosis / · Schizophrenia
· Hypertension / · Sleep Apnea
· Myocardial Infarction / · Smoking Cessation
· Social Anxiety Disorder
· Stroke
PROMETRIKA, LLC ¨ 725 Concord Avenue ¨ Cambridge, MA 02138
Phone: 617-868-2020 ¨ Fax: 617-868-2122
SUMMARY OF CRA EXPERIENCE (p. 2)
DERMATOLOGY / ENDOCRINOLOGY· Acne Vulgaris / · AIDS-Associated Catabolism/Wasting
· Actinic Keratosis / · Diabetes Mellitus
· Atopic Dermatitis / · Hormone Replacement
· Psoriasis / · Hypogonadism
· Rosacea / · Obesity
· Seborrheic Dermatitis / · Thyroid Disorder
· Tinea Pedis / · Xerostomia
GASTROENTEROLOGY / INFECTIOUS DISEASE
· Acid Reflux Disease / · Cryptococcal Meningitis
· Crohn’s Disease / · Fungal Infections
· C. difficile-Associated Diarrhea / · Hepatitis C
· Irritable Bowel Syndrome / · HIV/AIDS
· Peptic Ulcer Disease / · Neoplastic Meningitis
· Ulcerative Colitis / · Nosocomial Pneumonia
· Otitis (Externa, Media)
ONCOLOGY / · Sinusitis
· Acute Myeloid Leukemia / · Urinary Tract Infection
· Breast
· Bronchioloalveolar Carcinoma / OPHTHALMOLOGY
· Colon/Colorectal / · Blepharitis
· Glioblastoma Multiforme / · CMV Retinitis
· Head & Neck Carcinoma / · Conjunctivitis
· Kaposi’s Sarcoma / · Diabetic Macular Edema
· Leptomeningeal Disease / · Uveitis
· Lung
· Lymphoma / RESPIRATORY
· Melanoma / · Allergic Rhinitis
· Multiple Myeloma / · Asthma
· Myelodysplastic Syndrome / · Acute Respiratory Distress Syndrome
· Non-small Cell Lung / · Bronchitis (Acute, Chronic)
· Ovarian / · Chronic Obstructive Pulmonary Disease
· Primary Peritoneal Carcinoma / · Seasonal Allergies
· Prostate
· Pancreatic / UROLOGY
· Renal Carcinoma / · Acute Urinary Retention
· Soft Tissue Sarcoma / · Benign Prostatic Hypertrophy
· Erectile Dysfunction
· Overactive Bladder
· Urinary Incontinence
PROMETRIKA, LLC ¨ 725 Concord Avenue ¨ Cambridge, MA 02138
Phone: 617-868-2020 ¨ Fax: 617-868-2122