Experience

As a midsize clinical research organization (CRO) providing a broad range of services in multiple geographic regions, Cato Research is well suited to conduct multiple programs for various products. Cato Research has:

  • A proven track record of successful implementation of numerous trials
  • Significant experience managing large and complex multicenter studies
  • Responsive and stable project teams
  • A history of participation in numerous clinical trials that resulted in marketing authorizations by the FDA, Health Canada, and EMA
  • Experience with many external audits by sponsors and regulatory bodies without any critical findings
  • Reliable budget forecasting that minimizes the need for work order changes
  • A focus on quality people, quality data, and quality service to guarantee operational excellence
  • Proven, tried, and trusted track record

Cato Research has collaborated with multiple sponsors on research projects involving an array of products to treat multiple therapeutic areas that include those listed below. Cato Research has experience providing a full range of drug development services, including both clinical and regulatory activities — from preclinical projects to marketed products.

Our service experience includes preclinical and clinical strategy development; Investigation New Drug applications (INDs) authoring, compilation, and filing; annual report preparation; representation at FDA meetings; and Orphan Drug Application and Biologics License Application authoring, compilation, and filing. Learn more about our services >

Clinical service expertise includes clinical monitoring and management, data management, statistical support, protocol development and medical monitoring support. Additional services include general consulting, chemistry, manufacturing, and controls (CMC) consulting, and feasibility reports. Learn more about our clinical trial services >

Regulatory services expertise includes strategy and preparation or review relevant regulatory documentation. Additional services include assisting in compliance audits, licensing activities, and regulatory training. Cato Research also offers a regulatory database and system for handling the sponsor's regulatory files, useful for project status reports and inventories of auditable documents, which is much needed during study conduct and regulatory inspections. Learn more on about our regulatory affairs services >

In more than 25 years of service, Cato Research has gathered substantial experience in many different indications and with a wide variety of technologies — too numerous to list in full. The following represents some of the more substantial areas, but we encourage you to contact us to understand our relevant experience for any individual project.

Examples of our specialty areas are listed alphabetically below:

  • Cardiology

  • Highlights of our experience include, but are not limited to, the following:
    Acute coronary syndrome
    Angina pectoris (chronic stable, stable, Prinzmetal)
    Angioedema (hereditary)
    Angiogenesis
    Arrhythmia
    Atherosclerosis
    Cardiac ischemia
    Cardiovascular stent
    Coronary artery bypass graft
    Coronary artery disease
    Endocarditis
    Heart failure (congestive)
    Hypercholesteremia
    Hypertension
    Hypovolemic hypotension
    Lipodystrophy
    Myocardial ischemia/infarction
    Paroxysmal atrial fibrillation
    Peripheral vascular disease
    Pulmonary hypertension
    Pulmonary vein ablation
    Restenosis
    Suboptimal echocardiogram
    Supraventricular tachycardia (SVT)
    Syncope (bradycardic)
    Transmural myocardial infarction
    Vascular imaging for vascular disease

    Contact Us to Learn More about Our Experience and Expertise.


  • Dermatology

  • Highlights of our experience include, but are not limited to, the following:
    Actinic keratosis
    Atopic dermatitis
    Basal cell carcinoma
    Dermal scarring
    Diabetic wound healing
    Melanoma
    Mycosis fungoides
    Keloids
    Onychomycosis/tinea pedis
    Psoriasis

    Contact Us to Learn More about Our Experience and Expertise.


  • Devices

  • Highlights of our experience include, but are not limited to, the following:
    Needle-guide imaging software
    Cytologic sample preparation
    Dental hygiene
    Hearing aid
    Cancer brachytherapy
    Infusion pumps
    Cardiac catheter
    Cervical dysplasia screening
    Web‐based EEG analysis software
    Bladder cancer detection (combination product)
    Skin cancer (combination product)
    Spinal fusion/implants
    Various diagnostic products

    Contact Us to Learn More about Our Experience and Expertise.


  • Endocrinology / Metabolic

  • Highlights of our experience include, but are not limited to, the following:
    Diabetes
    Gaucher disease
    Hormone replacement
    Hyponatremia
    Osteopenia
    Thyroid disease
    Obesity
    Vitamin deficiency

    Contact Us to Learn More about Our Experience and Expertise.


  • Gastroenterology

  • Highlights of our experience include, but are not limited to, the following:

    Constipation
    Crohn disease
    Diarrhea
    Gastrointestinal cancers
    Gastric ulcers/erosions
    Gastroesophageal reflux disease
    Irritable (inflammatory) bowel syndrome/disease
    Short bowel syndrome
    Ulcerative colitis

    Contact Us to Learn More about Our Experience and Expertise.


  • Hematology

  • Highlights of our experience include, but are not limited to, the following:

    Anemia
    β‐Thalassemia
    Deep vein thrombosis
    Hemophilia
    Hypercholesteremia
    Hyponatremia
    Leukemia
    Lymphoma
    Myeloma
    Oxygen carrier/blood substitute
    Red blood cell storage
    Sickle cell disease
    Surgical bleeding control

    Contact Us to Learn More about Our Experience and Expertise.


  • Immunology / Rheumatology

  • Highlights of our experience include, but are not limited to, the following:

    Ankylosing spondylitis (arthritis)
    CIAS1-associated periodic syndromes
    Crohn disease
    Immunosuppressant
    Multiple sclerosis
    Primary immune deficiency
    Polymyalgia rheumatica
    Psoriatic arthritis
    Psoriasis
    Rheumatoid arthritis
    Scleroderma
    Short‐bowel syndrome
    Spondylitis
    Systemic juvenile idiopathic arthritis
    Ulcerative colitis

    Contact Us to Learn More about Our Experience and Expertise.


  • Infectious Disease

  • Highlights of our experience include, but are not limited to, the following:

    Anthrax
    Cytomegalovirus
    Endocarditis from MRSA
    Fungal infections
    Hepatitis
    HIV
    Infant Botulism
    Influenza
    Respiratory infection
    Sepsis
    Traveler’s diarrhea
    Tuberculosis
    Typhoid disease

    Contact Us to Learn More about Our Experience and Expertise.


  • Neurology / Psychiatry

  • Highlights of our experience include, but are not limited to, the following:

    Acute pain
    Chronic pain
    Epilepsy
    Huntington disease
    Multiple sclerosis
    Neuropathic pain
    Parkinson disease
    Muscular dystrophy
    Pseudo-bulbar affect
    Spinal cord injury
    Alzheimer disease/dementia
    Stroke

    Contact Us to Learn More about Our Experience and Expertise.


  • Obstetrics / Gynecology / Women’s Health

  • Highlights of our experience include, but are not limited to, the following:

    Breast cancer
    Breast implants
    Breastfeeding
    Cervical cancer
    Cervical screening
    Contraception
    Dietary supplement for pregnant and breastfeeding women
    Digital mammography
    Endometriosis
    Fibrocystic breast disease
    Menstrual cramps
    Osteoporosis
    Ovarian cancer
    Overactive bladder
    Pathogenic bacterial flora and yeast due to tampon use
    Polycystic ovarian syndrome
    Postmenopausal atrophy of vagina and urinary tract
    Postmenopausal estrogen deficiency
    Preterm labor
    Probiotic in infant formula
    Reconstructive breast surgery
    Tocolysis
    Vaginal hysterectomy, postoperative pain
    Vaginal pH reduction
    Vulvovaginal candidiasis

    Contact Us to Learn More about Our Experience and Expertise.


  • Ophthalmology

  • Highlights of our experience include, but are not limited to, the following:

    Age-related macular degeneration
    Diabetic retinopathy
    Dry eye syndrome
    Exudative macular degeneration
    Eye infection
    Glaucoma
    Ocular focusing
    Pure occult neovascularization

    Contact Us to Learn More about Our Experience and Expertise.


  • Oncology

  • Highlights of our experience include, but are not limited to, the following:

    Brain cancer
    Breast cancer
    Cancer‐related
    Colorectal cancer
    Gynecological cancers
    Gastric cancer
    Hematologic malignancies:
        Leukemia, myeloma, lymphoma
    Lung cancer
    Melanoma
    Pancreatic cancer
    Prostate cancer

    Contact Us to Learn More about Our Experience and Expertise.


  • Orphan Drugs

  • Highlights of our experience include, but are not limited to, the following:

    Amyotrophic lateral sclerosis
    Brain cancer
    CIAS1-associated periodic syndromes
    Duchenne muscular dystrophy
    Fabry disease
    Gastric cancer
    Genitourinary cancer
    Gaucher disease
    Hemophilia
    Mycosis fungoides
    Myeloma
    Pain: chronic, neuropathic
    Pancreatic cancer
    Parkinson's disease
    Pompe disease
    Polyposis coli
    Pulmonary arterial hypertension
    Scleroderma
    Sepsis
    Spinal cord injury
    Systematic ideopathic juvenile arthritis
    Typhoid

    Contact Us to Learn More about Our Experience and Expertise.


  • Pediatrics

  • Highlights of our experience include, but are not limited to, the following:

    Acute Otitis Media
    Dietary supplement for infants and pregnant women
    Duchenne muscular dystrophy (DMD)
    Effect of Infant Formula on Morbidity
    Gaucher Disease
    Head lice
    Hemolytic uremic syndrome
    Hemophilia
    Infant botulism
    Neonatal respiratory distress syndrome (RDS)
    Pediatric sleep apnea
    Pompe disease
    Probiotic in infant formula
    Systemic idiopathic juvenile arthritis

    Contact Us to Learn More about Our Experience and Expertise.


  • Rare Diseases

  • Highlights of our experience (with reference to the NORD's Rare Disease Database) include, but are not limited to, the following:

    Acquired hemophilia
    Acute respiratory distress syndrome
    Alpha-1 antitrypsin deficiency
    Ankylosing spondylitis
    Anthrax
    Apnea, infantile
    Apnea, sleep
    Arthritis, juvenile rheumatoid
    Arthritis, psoriatic
    Ataxia, Friedreich
    Autosomal dominant polycystic kidney disease
    Barrett esophagus
    Botulism
    Buerger disease
    Candidiasis
    Carcinoma, squamous cell
    Celiac disease
    Central diabetes insipidus
    Cervical dystonia
    Chagas disease
    Chlamydia
    Chronic lymphocytic leukemia
    Chronic myelogenous leukemia
    Crohn disease
    Cutaneous T-cell lymphomas
    Cystic fibrosis
    Duchenne muscular dystrophy
    Dystonia
    Encephalitis, herpes simplex
    Fabry disease
    Factor XI deficiency
    Factor XIII deficiency
    Familial hypercholesterolemia
    Fibromyalgia
    Gaucher disease
    Graft-versus-host disease
    Graves disease
    Growth hormone deficiency
    Hairy cell leukemia
    Hemophilia A and Hemophilia B
    Hepatitis B
    Herpes, neonatal
    Hodgkin's disease
    Hypoparathyroidism
    Idiopathic thrombocytopenic purpura
    Irritable bowel syndrome
    Legionnaires disease
    Leprosy
    Lupus
    Macular degeneration
    Malaria
    Mantle cell lymphoma
    Melanoma, malignant
    Ménière disease
    Meningococcal meningitis
    Multiple myeloma
    Multiple sclerosis
    Mycosis fungoides
    Paget disease
    Parkinson disease
    Phenylketonuria
    Pompe disease
    Psoriasis
    Pulmonary arterial hypertension
    Renal cell carcinoma
    Respiratory distress syndrome, infant
    Rett syndrome
    Scleroderma
    Short bowel syndrome
    Sickle cell disease
    Sjögren syndrome
    Stevens-Johnson syndrome
    Tardive dyskinesia
    Thrombotic thrombocytopenic purpura
    Tourette syndrome
    Turner syndrome
    Typhoid
    Ulcerative colitis
    Varicella zoster
    Von Hippel–Lindau (VHL) disease
    Zollinger-Ellison syndrome

    Contact Us to Learn More about Our Experience and Expertise.


  • Regenerative Medicine / Cell Therapies / Stem Cells

  • Highlights of our experience include, but are not limited to, the following:

    Graft-versus-host disease
    Advanced HIV
    Acute myocardial infarction
    Advanced melanoma and renal cell cancer
    Cartilage repair
    Ischemic stroke regulatory
    Myocardial infarction
    Degenerative joint disease

    Contact Us to Learn More about Our Experience and Expertise.


  • Respiratory Disorder / Pulmonology

  • Highlights of our experience include, but are not limited to, the following:

    Acute respiratory distress syndrome
    Alpha-1 antitrypsin deficiency
    Asthma
    Chronic obstructive pulmonary disease
    Neonatal respiratory distress syndrome
    Pulmonary arterial hypertension
    Respiratory tract infection
    Tuberculosis

    Contact Us to Learn More about Our Experience and Expertise.


  • Vaccines

  • Highlights of our experience include, but are not limited to, the following:

    Advanced cancer
    Anthrax
    Carcinoembryonic antigen vaccine
    Cytomegalovirus vaccine
    Ebola vaccine
    Escherichia coli
    Gastrointestinal cancer vaccine
    HIV/AIDS vaccine
    Influenza vaccine
    Marburg virus vaccine
    Melanoma vaccine
    Multiple sclerosis
    Pancreatic cancer
    Plague
    Prostate cancer
    Shigellosis
    Solid tumors
    Typhoid disease

    Contact Us to Learn More about Our Experience and Expertise.