Therapeutic Expertise

Therapeutic Expertise

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 below:

Oncology

Oncology
Request More Info

Cato Research has collaborated with more than 41 sponsors in Oncology research projects involving more than 30 different types of cancer indications in the past 10-15 years. Cato Research has conducted Phase 1 to Phase 4 oncology clinical trials involving sites located around the world. The list below demonstrates some of our broad range and depth of experience in this therapeutic area:

  • Advanced Cancer
  • Bladder Cancer
  • Brain Cancer, Neurological Cancer
  • Breast Cancer
  • Cancer Biologics and Proteins
  • Cancer Vaccines
  • Colon Cancer/Colorectal Cancer
  • Gastrointestinal
  • Gynecologic Cancers
  • Head & Neck Cancer
  • Hematological Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Lymphoma
  • Melanoma
  • Myeloma, Multiple Myeloma, Kahler's disease
  • Pancreatic Cancer
  • Prostate Cancer
  • Renal Cell Carcinoma
  • Solid Tumors

Advanced Therapies / Regenerative Medicine

Advanced Therapies - Regenerative Medicine: Cell and Gene Therapy
Request More Info

Cell Therapy

Cato Research has collaborated with many sponsors on research projects involving cell and gene therapy products and similar biologics to treat multiple therapeutic areas including oncology and infectious diseases, among others. Cato Research also has interacted extensively with the Food and Drug Administration’s (FDA) division of the Center for Biologics Evaluation and Research (CBER), the Office of Cell and Gene Therapy, as well as with the Canadian Health Products and Food Branch (HPFB). Ongoing contact with these groups provides us with the opportunity to maintain an awareness of current FDA/HPFB regulations, guidelines, and positions regarding monoclonal antibody development programs.

The following are examples of projects and expertise within Cato Research that are relevant to this field. These examples are illustrative and not exhaustive of the expertise available within Cato Research or its associates.

  • Autologous Dendritic Cell Therapy
      • Ovarian Cancer
  • Cell and Gene Therapy
      • HIV/AIDS
  • Cell Therapy
      • Cartilage repair in the knee
      • Degenerative Joint Disease of the knee
      • Melanoma, Malignant Melanoma, disseminated
      • Prostate Cancer
  • Stem Cell Therapy
      • acute leukemia, chronic myeloid leukemia, or myelodysplasia after bone marrow transplant to reduce graft-versus-host disease (GVHD)
      • Acute Myocardial Infarction
      • Ataxia
      • Bronchopulmonary Dysplasia

Gene Therapy

Gene Therapy, the use of DNA or RNA (including siRNAs or miRNAs) as a means to mitigate or cure disease, has the potential to transform medicine as we know it. The EMA has recently approved the Western world’s first gene therapy drug, Glybera from uniQure, to treat lipoprotein lipase deficiency. Treatments for conditions as diverse as Parkinson’s Disease, thalassemia, immunodeficiencies, coronary artery disease, ischemic stroke, and lymphoma, among others, are on the horizon as the field of Gene Therapy matures. Cato Research has the experience to translate these novel and complex technologies from the bench into clinical studies.

We have collaborated with many sponsors on research projects involving gene therapy products to treat multiple therapeutic areas, including oncology and infectious diseases, among others. Cato Research has provided scientific support for the development of a gene transfer vector, master cell bank, and cGMP manufacturing site for a gene therapy product and has experience providing a full range of drug development services including both clinical and regulatory activities. Cato Research has provided services including FDA and Recombinant DNA Advisory Committee (RAC) Meetings; Investigational New Drug Applications (IND) authoring, compilation and filing; annual report preparation; Orphan Drug Application (ODA) authoring, compilation and filing for multiple small molecules; and Biologics License Application (BLA) authoring, compilation and filing for a recombinant protein. Clinical services provided include 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.

The following are examples of projects and expertise within Cato Research that are relevant to this field. These examples are illustrative and not exhaustive of the expertise available within Cato Research or its associates.

  • Lentiviral-based cell based therapy
      • Advanced HIV
      • Naked DNA
      • Coronary artery disease
      • Peripheral vascular disease
  • Nanoparticle and DNA based therapy
      • Multiple myeloma
  • Viral gene therapy
      • Treatment for herpes viral infection
      • Treatment for cytomegaloviral infection
      • Pandemic influenza vaccine
      • Peripheral arterial disease
      • Musculoskeletal Disorder - Connective Tissue Disorder/Arthritis/Knees

Rare Diseases & Orphan Indications

Rare Diseases & Orphan Indications
Request More Info

CATO has significant experience and in house expertise in orphan indications and rare diseases, indications with small, difficult to recruit subject populations. CATO approaches these challenging projects with special emphasis on strategic development plans, the design and execution of effective regulatory strategies, and clinical trial design and conduct.

CATO has participated in numerous projects involving orphan drugs.  This participation includes preclinical, regulatory, clinical, statistical, and, manufacturing support.  CATO has authored and submitted to the FDA more than 35 successful orphan drug applications (ODA), amendments, and grants.  CATO has also designed and conducted pivotal clinical trials for a number of these orphan products as well as collaborated with numerous sponsors on multiple research projects involving more than 20 different types of orphan indications. Highlights of our experience in key indications are noted below.

  • Amyotrophic Lateral Sclerosis, Lou Gehrig's disease, ALS
  • Antivenom, snake bite, envenomation from North American Crotalid snakes
  • Bacillus Anthracis (Anthrax)
  • Bladder Cancer
  • Brain Cancer, GBM, high grade astrocytomas or mixed Gliomas
  • Buerger’s Disease/ Critical Limb Ischemia
  • CIAS1-Associated Periodic Syndromes (CAPS)
  • Duchenne Muscular Dystrophy (DMD), pediatrics
  • Ebola (vaccine), Marburg virus (MARV), Hemorrhagic fever
  • Fabry Disease
  • Gastric Cancer
  • Gaucher Disease
  • Hemolytic Uremic Syndrome Renal, pediatrics
  • Hemophilia
  • Infant botulism
  • Mycosis Fungoides, Alibert-Bazin syndrome, granuloma fungoides, cutaneous T-cell lymphoma
  • Myeloma, mab for ICAM-1 antigen
  • Pain: chronic, neuropathic
  • Pancreatic Cancer
  • Parkinson's Disease
  • Polyposis Coli, adenomatous polyposis coli (APC), sporadic adenomatous polyps
  • Pompe Disease
  • Pulmonary hypertension, pulmonary arterial hypertension (PAH)
  • Scleroderma
  • Sepsis, Septic Shock
  • Spinal Cord Injury, surgical
  • Systematic Idiopathic Juvenile Arthritis, pediatrics
  • Tuberculosis
  • Typhoid (vaccine)

Devices & Diagnostics

Devices & Diagnostics
Request More Info

Cato Research has collaborated with many sponsors on research projects involving device and diagnostic products to treat multiple therapeutic areas including cancer, respiratory diseases, and cardiology diseases, among others.

Cato Research has been involved with the development of medical devices for more than 50 different indications, has monitored and managed device clinical trials involving sites located worldwide; several of these device trials have involved complex study designs and invasive surgical procedures.

Below are a few examples of medical device studies, both completed and ongoing, that Cato Research has been extensively involved in:

  • Allergies (device test system)
  • Alzheimer’s Disease, Radio Frequency Device for Treating
  • Arrhythmia
  • Autism Diagnostic Device Kit
  • Bladder Cancer (Drug/Device Combination Diagnostic)
  • Blood Products
  • Brain monitoring device: Attention Deficit Hyperactivity Disorder, Traumatic Brain Injury, PTSD, and Dementia/Alzheimer’s
  • Breast Implant
  • Cardiomyopathy & CHF (Drug/Device Combo)
  • Cardiovascular Ablation Catheter
  • Cardiovascular Stent (Gene Therapy Device Combo)
  • Cartilage Repair Gel, surgical device implant study to treat cartilage lesions of the knee
  • Coronary Artery Disease
  • Cartilage Repair, articular cartilage repair of the knee device implant
  • Cell & Tissue Culture
  • Cervical Screening
  • Chronic Obtrusive Pulmonary Disorder (COPD) (Drug/Device Combo) Inhalation Solution
  • Chronic total occlusions (CTOs) in Coronary Artery Disease (Device Infusion)
  • Degenerative Disc Disease, joint replacement device
  • Dental Implants
  • Digital Mammography
  • Coronary Restenosis, Drug Delivery Catheter (Drug/Device Combo)
  • Emphysema
  • Endotoxin Detection Kit, Gram-negative, Innovative Receptor Technology (Diagnostic)
  • Gait Disorder (Neurostimulating Device Implant)
  • Hearing Aid
  • Hematology - Hemophilia/bleeding disorder, hemostasis disorders
  • HIV Diagnostic
  • Immunology/Rheumatology - Arthritis, Arthropathy
  • Immunology/Rheumatology- Fibromyalgia
  • In Vitro Diagnostics
  • Lead Detection in Blood (Diagnostic Device)
  • Medical Imaging Diagnostic
  • Neurology/Psychiatry - Acute Pain, Opioid Transdermal Patch, Surface device
  • Non-small cell lung cancer, Cell collection device for the monitoring of patients
  • Nonspecific indication, medical device/coatings
  • Ovarian Cancer (Diagnostic Device)
  • Skin Grafts/ Living Skin Replacement/ Diabetic Foot & Leg Ulcers
  • Surgical, laparoscopic device
  • Syncope Diagnostic
  • Transdermal Patches
  • Therapeutic Device
  • Therapeutic device for nerve gas poisoning
  • Valvular Heart Disease
  • Vertebroplasty

Neurology & Psychiatry

Neurology & Psychiatry
Request More Info

Cato Research has over 30 years of extensive experience in neurology and psychiatry. This experience involves collaborations with numerous sponsors including treatment of over 52 indications. To date, Cato Research has conducted over 200 clinical trials in central nervous system indications at sites throughout the world. Cato Research also interacts extensively with regulatory agencies such as the Food and Drug Administration (FDA) including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the European Medicines Agency (EMEA), Health Canada and the Canadian Health Products and Food Branch Inspectorate (HFBI). Ongoing contact with these regulatory groups keeps Cato Research up-to-date on current ICH, FDA, and HPFBI regulations, guidelines, and positions regarding neurology and psychiatry development programs.

Below are some indications that Cato Research has worked on in this therapeutic area:

  • Affective disorder
  • Alcoholism
  • Alzheimer disease
  • Amyotrophic lateral sclerosis (ALS), Lou Gehrig's disease
  • Anesthesia
  • Anxiety
  • Attention-deficit disorder (ADD), attention deficit / hyperactivity disorder (ADHD)
  • Central nervous system (CNS) disorders
  • Cerebral aneurysm
  • Chronic tinnitus
  • Claudication
  • Cognitive dysfunction
  • Dementia
  • Depression
  • Dravet syndrome
  • Eating disorder
  • Epilepsy
  • Gait disorder
  • Head injury (Concussion)
  • Headache/Migraine
  • Huntington disease
  • Insomnia
  • Multiple sclerosis (MS)
  • Muscular dystrophy (MD), Duchenne muscular dystrophy (DMD), oculopharyngeal muscular dystrophy (OPMD)
  • Narcolepsy
  • Neurally mediated syncope
  • Neuropathy
  • Pain (acute: postsurgical pain, postinjury pain, orthopedic pain; chronic; neuropathic)
  • Parkinson’s disease
  • Pediatric sleep apnea
  • Personality disorder
  • Pseudobulbar affect (PBA)
  • Psychosis
  • Schizophrenia
  • Sedative, sedation
  • Sleep disorder
  • Smoking cessation, nicotine addiction
  • Spasticity
  • Spinal injury, spinal cord injury, Spinal Cord Disorder
  • Stroke, ischemic stroke, acute ischemic stroke
  • Tourette syndrome/ Tic Disorder
  • Traumatic brain injury

Infectious Disease

Infectious Disease
Request More Info

Cato Research has significant experience in the development of products to treat infectious diseases and has successfully worked on both regulatory and clinical development in this area.  We have found that flexibility can be paramount in achieving clinical milestones.  For example, we have worked with several sponsors recently to achieve challenging corporate goals, including conducting an entire Phase 1 study in 10 weeks and locking a clinical database for a Phase 3 study within days of the last patient’s last visit.

Highlights of Cato Research’s experience in infections disease includes, but not limited to, the following indications:

  • Anthrax
  • Antibiotic
  • Antifungal
  • Antimicrobial
  • Acute Respiratory Distress Syndrome (ARDS)
  • Clostridium Difficile Associated Diarrhea (CDAD)
  • Cryptosporidiosis, Crypto, Cryptosporidium
  • Cryptococcal meningitis
  • Cytomegalovirus (CMV)
  • Escherichia coli
  • Enterotoxigenic (ETEC)
  • Ebola (vaccine), Marburg virus (MARV), hemorrhagic fever
  • Endocarditis from methicillin resistant Staphylococcus aureus (MRSA)
  • Fever
  • Head lice
  • Hepatitis B and C
  • Herpes simplex virus
  • HIV/AIDS
  • HIV-related lipotrophy
  • Infant botulism
  • Influenza
  • Leprosy
  • Otitis media, middle ear infection
  • Respiratory tract infection
  • Sepsis/Septic Shock
  • Shigellosis (vaccine)
  • Smallpox
  • Traveler’s diarrhea
  • Tuberculosis
  • Typhoid disease (vaccine)
  • Viral infection

Endocrinology & Metabolic

Endocrinology & Metabolic
Request More Info

Cato Research has collaborated with many sponsors on multiple research projects involving endocrine and metabolic diseases and conditions. Cato Research has conducted Phase 1 to Phase 4 clinical trials involving sites located around the world. Cato Research also has interacted extensively with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with divisions of the Center for Biologics Evaluation and Research (CBER), as well as with the Canadian Health Products and Food Branch (HPFB). Ongoing contact with these groups provides us with the opportunity to maintain an awareness of current FDA/HPFB regulations, guidelines, and positions regarding development programs.

Highlights of our experience in key indications are included, but not limited to, the list:

  • Acetaminophen Toxicity
  • Acromegaly
  • Alpha-1 Antitrypsin Deficiency
  • Cachexia
  • Calcium/Phosphate/Magnesium Homeostasis
  • Diabetes Mellitus
  • Atherosclerosis
  • Foot & Leg Ulcers
  • Gastroparesis
  • Kidney Disease
  • Retinopathy
  • Diabetic Neuropathy
  • Dietary Supplement for Infants and Pregnant Women
  • Diet & Lipid Disorder
  • Dyslipidemia
  • Enzyme Replacement Therapy
  • Estrogen Deficiency
  • Fabry Disease
  • Gaucher Disease
  • Gout
  • Hormone Replacement
  • Hyperlipidemia
  • Hyperphosphatemia
  • Hypertriglyceridemia
  • Hyponatremia
  • Inborn Error/Genetic Deficiency
  • Iron/ B12/ Folate Disorder
  • Lymphedema
  • Malabsorption
  • Nutrition
  • Obesity
  • Osteopenia
  • Osteoporosis
  • Parathyroid Disorder
  • Pertussis
  • Pompe Disease
  • Rickets -X-linked Hypophosphatemic
  • Satiety
  • Thalassemia
  • Thyroid Disease
  • Vitamin B-12 Replacement

Cardiology & Vascular

Cardiology & Vascular
Request More Info

Cato Research has significant, in-depth experience and in-house expertise in the clinical development of pharmaceutical agents for the treatment or prevention of cardiac and vascular diseases. Cato Research has participated in multiple research projects involving cardiology and vascular disease products. This participation includes regulatory and nonclinical services, clinical trial conduct and management, and manufacturing of compounds for these diseases.

Members of Cato Research’s clinical trial operations team have extensive skill in conducting studies pertaining to cardiology and vascular diseases such as the treatment of myocardial infarction, arteriosclerosis, critical limb ischemia, the treatment of angina pectoris, acute coronary syndrome, coronary artery disease, endocarditis, supraventricular tachycardia, hypertension, congestive heart failure, and arrhythmia.

Cato Research has extensive experience in cardiovascular indications and has conducted multiple, successful studies in such diseases. Services provided include protocol and Investigator’s Brochure development, strategic consulting, clinical monitoring and management, medical monitoring, pharmacovigilance, electronic data capture, statistical analysis, and medical writing (including annual report, clinical study reports, development plan, protocol and amendments, Investigator’s Brochures, and publications).

Cato Research has also performed various other activities in cardiovascular research and development, such as manufacturing oversight, preparation and submission of United States Investigational New Drug applications (INDs) and European and Canadian Clinical Trial Applications, and conduct of Food and Drug Administration (FDA) meetings.

Highlights of our cardiology and vascular experience in a broad range of indications in multiple geographic regions is included, but not limited to, the list below:

  • Acute coronary syndrome
  • Angina pectoris
  • Angioedema, hereditary
  • Angiogenesis
  • Arrhythmia
  • Atherosclerosis
  • Cardiac ischemia
  • Cardiomyopathy/CHF
  • Cardiovascular stent
  • Coronary artery bypass graft (CABG)
  • Coronary artery disease (CAD), heart disease, valvular heart disease
  • Critical limb ischemia
  • Diet and lipid disorder
  • Endocarditis (MRSA [methicillin-resistant Staphylococcus aureus])
  • Foot and leg ulcers
  • Heart failure, congestive
  • Hypercholesterolemia
  • Hypertension
  • Hypovolemic hypotensionLipodystrophy
  • Myocardial ischemia, myocardial infarction
  • Paroxysmal atrial fibrillation
  • Peripheral vascular disease
  • Pulmonary hypertension, pulmonary arterial hypertension (PAH)
  • Pulmonary vein ablation
  • QTc intervals, heart electrical cycle
  • Restenosis
  • Stroke, Cerebrovascular Accident (CVA), Cerebrovascular Insult (CVI)
  • Suboptimal echocardiogram
  • Supraventricular tachycardia (SVT)
  • Syncope, bradycardic
  • Thromboembolism, Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE)
  • Transmural myocardial infarction
  • Vascular imaging for vascular disease

Gastroenterology & Hepatology

Gastroenterology & Hepatology
Request More Info

Cato Research has collaborated with many sponsors on multiple research projects involving gastroenterology agents to treat a wide variety of gastric conditions and digestive disorders.  Cato Research has conducted Phase 1 to Phase 4 gastroenterology clinical trials involving sites located around the world.  Cato Research also interacts extensively with the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research and with divisions of the Center for Biologics Evaluation and Research, as well as with the Canadian Health Products and Food Branch (HPFB).  The ongoing contact with these groups keeps Cato Research aware of current FDA and HPFB regulations, guidelines, and positions regarding gastroenterology development programs.

Cato Research’s clinical trial operations team members are extensively skilled in conducting studies in the following areas pertaining to the treatment of ulcerative colitis, short-bowel syndrome, peptic ulcers, gastroesophageal reflux disease and colon polyps, but are also skilled in conducting studies pertaining to the treatment of irritable bowel disease and Crohn disease.

Highlights of Cato Research’s gastroenterology experience are listed below.  Additional indications or information can be provided upon request.

  • Cirrhosis
  • Colon atony
  • Colon polyps: adenomatous polyposis coli
  • Constipation
  • Crohn disease
  • Diarrhea, traveler’s diarrhea, ETEC/enterotoxigenic Escherichia coli
  • Enteritis
  • Esophageal varices
  • Exocrine pancreatic insufficiency
  • Fecal impaction
  • Gastric ischemia
  • Gastrointestinal cancer: Gastric, Gastroesophageal
  • Gastroenteritis
  • Gastroparesis
  • Gastroduodenal erosions
  • Gastroesophageal reflux disease (GERD)
  • Hepatic disorder
  • Iron overload: Thalassemia syndromes, Liver chelation therapy
  • Irritable (inflammatory) bowel disease/inflammatory bowel syndrome (IBD/IBS), inflammatory disease
  • Lactose intolerance
  • Non-alcoholic Steatohepatitis (NASH)
  • Pancreatic Disorder
  • Peptic/gastric ulcer disease, stomach ulcers
  • Postoperative ileus
  • Primary Sclerosing Cholangitis
  • Short-bowel syndrome
  • Steatorrhea in patients with short-bowel syndrome
  • Ulcerative colitis

Hematology

Hematology
Request More Info

Clinical-stage hematology research is a notoriously complex field that can be mired by difficulty in patient recruitment, complicated regulatory strategy, and complex clinical study design. However, the demand for novel hematology products has never been greater. Cato Research has significant experience designing hematology regulatory and clinical strategy in addition to managing clinical trials to translate novel and complex technologies from the bench to the market.

Cato Research has collaborated with many sponsors on research projects involving hematology products to treat multiple therapeutic areas including hyponatremia, red blood cell storage, blood substitutes, and deep vein thrombosis, among others. Cato Research has experience providing a full range of drug development services including both clinical and regulatory activities. Services provided include preclinical and clinical strategy development; Investigation New Drug Applications (IND) authoring, compilation and filing; annual report preparation; representation at FDA meetings; and Orphan Drug Applications (ODA) and Biologics License Application (BLA) authoring, compilation and filing. Clinical services provided include 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.

Highlights of our hematology experience are included, but not limited to, in the key indication list below:

  • Acute Anemia
  • Anticoagulation
  • Antithrombotic Therapy
  • Blood Clots
  • Blood Transfusion
  • Blood Replacement Product
  • Blood Storage
  • Coronary Artery Bypass Graft
  • Fanconi Anemia
  • Hematologic Malignancies:
  • Acute Lymphoblastic: Leukemia
  • Acute Myeloid Leukemia
  • Anaemia following: myelotoxic therapy
  • Bone Marrow Transplant
  • Chronic Lymphocytic: Leukemia
  • Chronic Myeloid: Leukemia
  • Gleevec-resistant Chronic: Myelogenous Leukemia
  • Graft Versus Host Disease (GVHD), Post bone: marrow transplant, in Leukemia
  • Lymphoma
  • Mantle Cell Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Non-Hodgkin's Lymphoma
  • Hemodialysis Graft Occlusion
  • Hemolytic Uremic Syndrome Renal (HUS)
  • Hemoglobin-Based Oxygen Carriers
  • Hemophilia A (Factor VIII deficiency)
  • Hemophilia B
  • Hemophilia C (Factor XI deficiency)
  • Hemophilia Factor V deficiency
  • Hemophilia Factor VII deficiency
  • Hypercholesteremia
  • Hyperlipidemia
  • Hyperprotenemia
  • Hypoplasminogenemia
  • Hyponatremia
  • Hypovolemia: Hypotension, Post Traumatic
  • Intravenous Immune Globulin for Infant Botulism
  • Idiopathic Thrombocytopenic Purpura
  • Myelofibrosis (MF) / Myeloproliferative: Myeloid metaplasia / Agnogenic myeloid metaplasia / Myelofibrosis with myeloid metaplasia (MMM)
  • Oxygen Carrier/Blood substitute
  • Peripheral Arterial Occlusions
  • Pernicious Anemia
  • Plasma Volume Expander
  • Platelet Replacement Product
  • Pulmonary Embolism
  • Recombinant Factor Concentrate
  • Red Blood Cell Storage/Therapy
  • Sickle Cell Disease (SCD) / Sickle Cell Anemia (SCA)
  • Stem Cell Replacement Therapy
  • Surgical Bleeding Control
  • β-thalassemia/ Thalassemia Anemia
  • Thrombosis: Deep Vein
  • Transmural Myocardial Infarction

Dermatology

Dermatology
Request More Info

Cato Research has provided services for a variety of dermatologic indications, including burns, scarring, keloids, and skin grafting. Other indications include sunless tanning, rhytid reduction, skin cancers, psoriasis, and dermatitis. Cato Research has provided early-stage development services such as nonclinical program design, CMC consultation, pre-IND meetings, IND and other regulatory filings, as well as clinical services. Clinical services performed in support of Phases 1, 2, and 3 dermatology studies have included site selection and study setup, clinical management and monitoring, data management, statistics, and medical writing.

The following are examples of projects and expertise within CATO that are relevant to dermatological products. These examples are illustrative and not exhaustive of the expertise available within CATO or its associates.

  • Acne
  • Acne scars
  • Actinic keratosis
  • Alopecia
  • Atopic dermatitis
  • Basal cell carcinoma
  • Burns
  • Chronic wound healing
  • Corticosteroid responsive dermatosis
  • Dermal scarring
  • Dermatitis
  • Dermatomyositis
  • Diabetic foot/leg ulcer
  • Diabetic wound healing
  • General dermatology
  • Glabellar rhytides
  • Head lice
  • Hypertrophic scar formation: postsurgical
  • Keloids
  • Large Wounds
  • Mycosis fungoides
  • Onychomycosis/tinea pedis
  • Pain: acute soft-tissue injuries
  • Psoriasis
  • Rhytids dermal depressions
  • Scar reduction
  • Scleroderma
  • Skin cancer: Melanoma, Basal cell carcinoma, Kaposis sarcoma
  • Skin flap grafts
  • Skin protection
  • Sunless tanning
  • Urticaria

Respiratory & Pulmonology

Respiratory & Pulmonology
Request More Info

Cato Research has in-depth experience and expertise in the development of treatment for disorders and infections of the lungs and respiratory tract, with special emphasis on the design and execution of effective clinical studies in this area. Cato Research has participated in multiple research projects involving treatment development in this area, including the design and implementation of protocols and clinical and regulatory strategy.

Cato Research has also supported all facets of product development in this therapeutic area including regulatory, nonclinical, manufacturing, clinical trial monitoring and management, and statistics and medical writing.

Cato Research has provided extensive regulatory services including, but not limited to FDA Meetings; Investigational New Drug Applications (IND) authoring, compilation, and filing; annual report preparation; Orphan Drug Application (ODA) authoring, compilation, and filing; and Biologics License Application (BLA) authoring, compilation and filing. Clinical services provided include clinical monitoring and management; data management; statistical support; protocol development; and medical monitoring support. Additional services include preclinical and general consulting; Chemistry, Manufacturing and Controls (CMC) consulting; and feasibility reports.

The following are examples of projects and expertise within Cato Research that are relevant to this field. These examples are illustrative and not exhaustive of the expertise available within Cato Research or its associates.

  • Alpha1-Proteinase Inhibitor Deficiency (Lung Symptoms)
  • Acute Lung Injury
  • Allergy and Colds
  • Asthma/bronchial asthma: novel anti-inflammatory
  • Chronic Obstructive Pulmonary Disease (COPD): Combination Bronchodilator Product, anti-mucosal product, w/ chronic bronchitis, w/ bronchoconstriction
  • Chronic Pulmonary Infection in Cystic Fibrosis Patients
  • Cystic Fibrosis
  • Emphysema: bronchial device
  • Idiopathic Pulmonary Fibrosis
  • Inflammatory Respiratory Syndrome
  • Pertussis
  • Pneumonia
  • Pulmonary Embolism: Lung
  • Pulmonary Hypertension: Pulmonary Arterial Hypertension (PAH), inhaled treatment, Primary Pulmonary Hypertension
  • Respiratory Distress Syndrome (RDS)(ARDS): Acute Severe, Adult, Neonatal, In Premature Infants
  • Respiratory Tract Infection: Antibiotic
  • Tuberculosis (TB)

Immunology & Rheumatology

Immunology & Rheumatology
Request More Info

Cato Research has in-depth experience and in house expertise in a variety of immunological and inflammatory disease indications. Cato Research approaches these challenging projects with special emphasis on strategic development plans, the design and execution of effective regulatory strategies, and clinical trial design and conduct.  Cato Research has conducted multiple successful clinical trials, Phase 1 through 3, in a variety of autoimmune disorders.

The following are examples of projects and expertise within Cato Research that are relevant to immunology and rheumatology products. These examples are illustrative and not exhaustive of the expertise available within CATO or its associates.

  • Allergic Rhinitis
  • Allergy
  • Arthritis: Ankylosing Spondylitis, Psoriatic Arthritis, Systemic Juvenile Idiopathic
  • Ataxia - Telangiectasia
  • Autoimmune Disease
  • CIASI Associated Periodic Syndromes (CAPS)
  • Crohn’s Disease
  • Familial Cold Syndromes
  • Hereditary Angioedema (HAE)
  • Immunodeficiency
  • Immunosuppressant
  • Lupus Nephritis
  • Multiple Sclerosis
  • Organ Transplant
  • Osteoarthritis
  • Osteoporosis: Vitamin
  • Psoriasis
  • Polymyalgia Rheumatica
  • Primary Immune Deficiency
  • Rheumatoid Arthritis
  • Scleroderma
  • Ulcerative Colitis

Nephrology & Urology

Nephrology & Urology
Request More Info

Cato Research has collaborated with many sponsors on multiple research projects involving agents to treat a wide variety of nephrology and urology disorders.  Cato Research has conducted Phase 1 to Phase 4 clinical trials involving sites located around the world.  Cato Research also has interacted extensively with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with divisions of the Center for Biologics Evaluation and Research (CBER), as well as with the Canadian Health Products and Food Branch (HPFB).  Ongoing contact with these groups provides us with the opportunity to maintain an awareness of current FDA/HPFB regulations, guidelines, and positions regarding development programs specific to nephrology and urology diseases.

Highlights of our experience in key indications are included in the following list.

  • Atonic Bladder/Bladder Atony
  • Benign Prostatic Hypertrophy (BPH)
  • Benign Prostatic Hyperplasia
  • Bladder Cancer
  • Diabetic Nephropathy/
  • Diabetic Kidney Disease
  • Erectile Dysfunction
  • Lupus Nephritis
  • Hemodialysis Graft Occlusion
  • Hemolytic Uremic Syndrome (HUS)
  • Interstitial Cystitis/Painful Bladder Syndrome
  • Kidney Disorder
  • Postmenopausal Atrophy of Urinary Tract
  • Prostate Cancer
  • Renal Cell Carcinoma/Cancer
  • Renal Cell Lung Metastases
  • Renal Failure/Renal Impairment: Acute Kidney Injury:novel anti-inflammatory product
  • Renal Transplant
  • Urinary Incontinence/Overactive Bladder/ Bladder Disorder
  • Urological Neoplasms
  • Urinary Tract Infection
  • Von Hippel-Lindau Disease (kidney tumors)

Obstetrics / Gynecology / Women’s Health

Obstetrics, Gynecology, Women’s Health
Request More Info

Cato Research has collaborated with numerous sponsors on multiple research projects geared towards the treatment of indications in obstetrics, gynecology, and women’s health. Cato Research also has interacted extensively with the Food and Drug Administration (FDA), namely the Center for Drug Evaluation and Research Division and the Center for Biologics Evaluation and Research Division, as well as with the Canadian Health Products and Food Branch. Ongoing contact with these agencies provides us the opportunity to maintain an awareness of their current regulations, guidelines, and positions regarding development programs specifically for women’s health.


Cato Research’s clinical trial operations team members not only have extensive knowledge in studies pertaining to the development of contraception, but are also skilled in conducting studies pertaining to the treatment of osteoporosis, endometriosis, pathogenic bacterial flora and yeast, fibrocystic breast disease, menstrual cramps, polycystic ovarian syndrome, post-operative pain associated with vaginal hysterectomy, overactive bladder, tocolysis, preterm labor, breast and ovarian cancers and conditions associated with menopause such as atrophy of the vagina and urinary tract and estrogen deficiency.


Highlights of our experience in key indications are included in the following list:

  • Breast Cancer
  • Breast Implants
  • Breastfeeding
  • Cervical Cancer
  • Cervical Screening
  • Contraception
  • Dietary Supplement for Pregnant and Breastfeeding women
  • Digital Mammography
  • Endometriosis
  • Fibrocystic Breast Disease
  • Gynecological Cancer
  • Infertility
  • 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
  • Pregnancy
  • Preterm Labor
  • Probiotic in Infant Formula
  • Reconstructive Breast Surgery
  • Tocolysis
  • Vaginal Hysterectomy, post-operative pain
  • Vaginal pH reduction
  • Vaginitis, Vaginal infection
  • Vulvovaginal Candidiasis (VVC), yeast infection, fungal infection

Pediatrics

pediatrics
Request More Info

Cato Research has collaborated with many sponsors on research projects involving pediatric, congenital, and genetic products to treat and help diagnose multiple therapeutic areas including Autism, Duchenne Muscular Dystrophy, Hemophilia, Infant Botulism, among others.

In addition, CATO has experience working with pediatric patients, especially those with rare diseases that would involve issues such as informed consent/assent/legal authorized representative. Through this experience, CATO is familiar with the logistical issues of these unique trials, such as study enrollment, tracking and managing study-related regulatory documentation (including, but not limited to, protocol amendments, 1572s, Investigator’s Brochures), and working with the clinical investigators at the regional medical centers. This practical knowledge is valuable in the design of clinical trials and the formulation of the overall regulatory strategy for pediatric, congenital and genetic products, including preparing Pediatric Study/Investigation Plans for both the United States and Europe.

The following are examples of projects and expertise within Cato Research that are relevant to pediatric, congenital, and genetic field. These examples are illustrative and not exhaustive of the expertise available within Cato Research or its associates.

  • Addictions
  • Achromatopsia
  • Aromatic L-Amino Acid Decarboxylase Deficiency
  • Attention-deficit disorder (ADD), attention deficit/hyperactivity disorder (ADHD)
  • Arthritis/ Anthropathy
  • Asthma
  • Autism diagnostic
  • Brain Cancer: Neuroblastoma, vaccine
  • Bronchopulmonary Dysplasia
  • Calcium/Phosphate/Magnesium Homostasis
  • Chronic Pulmonary Infection in Cystic Fibrosis Patients
  • CNS Tumor
  • Cognitive Dysfunction
  • Cold
  • Cystic Fibrosis
  • Depression
  • Diabetes: Type 1
  • Dietary Supplement for Infants and Pregnant Women
  • Duchenne Muscular Dystrophy (DMD)
  • Effect of Infant Formula on Morbidity
  • Exocrine Pancreatic Insufficiency
  • Fabry Disease
  • Fragile X
  • Gaucher’s Disease
  • Genetic-Alpha-Mannosidosis
  • Head Lice
  • Hemolytic Uremic Syndrome
  • Hemophilia (Factor VIII)
  • Hemophilia A
  • Infant Botulism
  • Infant Nutrition/Infant Formula
  • Molluscum Contagiosum
  • Neonatal Respiratory Distress Syndrome
  • Obesity
  • Organ Transplant Children with SCID-Severe Combined Immunodeficiency
  • Otitis Media
  • Pediatric Sleep Apnea
  • Platelet Disorder
  • Pneumonia
  • Pompe Disease
  • Primary Sclerosing Cholangitis
  • Probiotic in Infant Formula
  • Recombinant Human Arginase I (hArg1)
  • Respiratory Failure
  • Rett Syndrome
  • Sepsis/ Bacterial Infection
  • Sickle Cell Disease
  • Systemic Juvenile Idiopathic Arthritis (sJIA)
  • Traumatic Brain Injury
  • Tourette syndrome/ Tic Disorder
  • Viral Infection
  • Urea Cycle Disorder