Clinical Study Management

We can manage all aspects of your clinical study including Project Management, Regulatory, Biostatistics, Site Selection and Feasibility, as well as eCRF design and configuration.

Medical Monitoring Services

We have a complete team of global CRAs and Lead CRAs providing Quality Control Visits as well as Co-Monitoring Visits and more.

Medical Writing

Our Medical Writers take care of all of your medical writing needs including Protocol Writing, SRM, CMP, Clinical Study Reports, Publications and Manuscripts, IND Preparation and NDA Section Writing.

Safety / Pharmacovigilance

Our Medical Monitoring Team can manage all of your Safety and Pharmacovigilance needs including Safety Management Setup, AE / SAE Case Processing, Safety Narrative Writing and Safety Report Submissions.

 

Auditing Services

Our Auditors can tackle all of your auditing requirements including Auditing of Sponsors, CRO's and Vendors, Compliance Audits and Project Audits.

Call Us Today!

Our team of experts are ready to assist you with your projects today. Call now and speak with our team about your specific requirements.

Therapeutic Areas

Our clinical research teams work in multiple Therapeutic Areas/Indications (PH I-IV) and have tremendous depth of experience within all of these areas.

Cardiovascular

Acute MI (thrombolytics), Angina, Arrythmia, A-Fib, CABG, CAD, CHF, Endocarditis, Hypercholesterolemia, Hyperlipidemia, Hypertension, Intermittent Claudication, STEMI, Tachycardia, Vascular Disease.

CNS

Anti-Anxiety, Alzheimers Disease, Parkinsons Disease, ADHD, Hyperactivity, Migraine, PTSD, Insomnia, Seizures, Myasthenia Gravis, Neuropathic Pain, Panic Disorder, Tourette Syndrome, Lambert Eaton Myasthenic Syndrome, Downbeat Nystagmus, Congenital Mysthenic Syndrome and Infantile Spasms.

Dermatology

Acne, Antiviral, Alopecia, Actinic Keratosis, Dermatitis, Dermal Fillers (BOTOX),Hidradenitis Suppurativa, Ischemic, Wound Therapy, Ezcema, Psoriasis, Venous Leg Ulcers.

Devices

Breast Implants, Diabetic Inhaler, Epilepsy, Left Ventricular Assist System - LVAS, Thrombectomy System, Coronary Stent, IntraOcular Implants for Hyperopia / Myopia / Presbyopia, Vaginal Rings, Vaccine Trials.

Endocrinology

Diabetes (Type I & II), Diabetic Foot Ulcer, Diabetic Neuropathy.

Gastroenterology

Cirrhosis, Diabetes (Type I & II), Diabetic Foot Ulcer, Diabetic Neuropathy, NASH

Immunology

Multiple Sclerosis, OA, RA, Solid Organ Transplant.

Infectious Disease

AIDS(HIV), Antibiotics, Cytomegalovirus, Hepatitis B, Herpes Simplex 1 & 2.

Internal Medicine

Allergies, Common Cold, Gout, Influenza, Obesity, Seasonal Allergic Rhinitis, Tobacco Studies

Neurology

Chronic Non-Malignant Pain, Convulsions, Epilepsy, Fibromyalgia, Headache, Insomnia, Migraines, Mulltiple Sclerosis, Muscular Dystrophy, Myasthenia Gravis, Narcolepsy, Obstructive Sleep, Apnea / Hypopnea (OSA), Pain Management, Post-Herpetic Neuralgia, Spinal Cord Injury, Stem Cell, Stroke ischemic / hemorragic.

Nephrology

Diabetic Nephropathy, Renal Failure.

Oncology

Breast / Colorectal / Lung / Ovarian / Prostate / Bladder Cancer, Upper GI, Chronic Cancer Pain, Malignant Melanoma, Multiple Myeloma, Pediatric Oncology, Solid Tumors (NSCLC, head and neck, soft tissue sarcoma).

Ophthalmology

AMD (wet/dry), Diabetic Retinopathy, Dry Eye, FECD, Hyperopia / Myopia / Presbyopia, glaucoma,IOL, LASIK, PRL (Phakic Refractive Lens) Macular Edema (retinopathy).

Pediatrics

ADHD, Antibiotics, Depression, Fragile X, Otitis Media, Pediatric Cancer, Pediatric Vaccines, Pre Term Neonates, Sickle Cell Disease.

Psychiatry

Alzheimers, Anxiety(GAD / SAD), Bipolar Disease, Dementia, Depression, OCD, Parkinsons Disease, Schizophrenia, Major Depressive Disorder(MDD).

Pulmonology

ADV (AdenoVirus) Vaccine, Asthma, Bronchitis (AECB) , CAP, COPD, Chronic Cough, Emphysema, Interstitial Lung Disease (ILD), Pulmonary Hypertension, Respiratory Distress.

Rheumatology

Arthritis, Rheumatoid Arthritis, Osteoarthritis.

Surgery

Post-op pain, Recombinent Human Thrombin (hepatic resection, PAB,AV Graft).

Urology

BPH, Urinary Stress Incontinence, UTI.

Vaccines

Cholera, COVID, flu.

Women’s Health

Oral Contraceptives, Female Stress Urinary Incontinence, Hormone Replacement, Menopause, Osteoporosis Pelvic Organ Prolapse, PolyCystic Ovary Syndrome (PCOS), Vaginal Atrophy,Overactive Bladder (OAB), HPV (Human PapillomaVirus).

Orthopedics

Device in spine and extremities, OA of the Knee