Therapeutic Expertise

 

 

 

 

 

There is no shortcut to achieving therapeutic expertise.

Since 1991, Criterium has been developing programs that serve your needs to get the job “Done right and on time!” By offering a range of high-quality services along the drug development continuum, you can choose the service that meets one or all of your study management process requirements.

The commitment to quality resources and procedures is a Criterium hallmark. We can proudly point to a record of successfully preparing and coordinating clinical trials for regulatory submission, while meeting all critical interim milestones in the process.

This process of meeting time-sensitive and multiple deadlines is guided by Criterium’s staff of board certified physicians who are trained in medical writing for various areas of your trials. The data flow is optimized by Criterium’s proprietary real-time technology solutions such as TeleDiary™ Interactive Voice Response system and StudyControl™ Clinical Trial Management system. These technologies are available to all of our regional offices worldwide on a 24/7/365 basis to make the workflow as efficient as possible.

The following list is a small sample of the Therapeutic Expertise Categories (as well as experience with trials on a variety of medical devices, delivery systems and media) that Criterium has developed by servicing clients worldwide. Our representatives will be happy to share specific details upon request. A list of therapeutic applications follows each category:

Allergy:

We have conducted a number of Phase II-IV clinical and therapeutic bio-equivalence allergy studies in the United States and South Africa. We have investigated steroid and antihistamine drug preparations in different formulations, including intra-nasal and oral. With offices in both hemispheres, we are able to meet the strictest timelines. This is specifically critical for seasonal allergy studies because we can conduct trials almost year round. Our two board-certified physicians can provide guidance and medical writing services for your allergy and respiratory trials, including:

• Perennial Allergic Rhinitis
• Seasonal Allergic Rhinitis
• Bacterial Sinusitis
• Allergic conjunctivitis
  

 

 

 

Cardiovascular Diseases:

Criterium has worked on a variety of cardiovascular diseases studies and has applied technology to the successful control of patient screening, validation before randomization and continued compliance during therapy. Criterium has conducted studies in the following areas:

• Arrhythmias
• Congestive Heart Failure
• Coronary Artery Bypass Graft Surgery (CABG) Follow up
• Deep Vein Thrombosis
• Hypertension
• Thrombosis

 

 

Central Nervous System:

Criterium has worked on studies covering a variety of CNS indications. We have experience used a number of different technologies to register and randomize patients as well as collect data in real-time.

• Alzheimer’s disease
• Anti-depressant
• Anti-psychotic for schizophrenia
• Anxiolytic
• Chronic fatigue syndrome
• Epilepsy
• Multiple sclerosis
• Sleep induction
• Smoking cessation

 

 

Delivery Methods:

• Buccal (Cheek)
• Inhalation
• Intranasal
• Intrathecal
• Intravenous
• Transdermal
• Oral

 

 

 

 

Dermatology:

• Actinic keratosis
• Artificial skin
• Burn debridement
• Decubitus ulcer
• Diabetic foot ulcer
• Fungal infections
• Impetigo
• Onychomycosis
• Tinea pedis
• Tinea versicolor
• Wrinkles

 

 

Gastroenterology:

• Crohn’s disease
• Duodenal ulcer
• Esophagitis
• Fabry disease
• Gastric ulcer

 

 

 

 

 

Hematology:

• Anemia from cancer treatments
• Anemia from thermal iInjury
• Hemophilia
• Hemophilia factor VIII
• Sickle cell anemia
• Von Willebrand’s disease

 

 

 

 

 

 

Infectious Diseases:

Criterium has worked in various capacities to conduct studies in patients with Infectious Diseases. Our office in South Africa is a platform for conducting HIV studies in sub-Saharan Africa. Our South Africa staff is experienced in the management of vaccine and therapeutic studies. Difficult-to-find populations are usually more readily available for studies in South Africa. Criterium also provides pharmacy management services as well as clinical monitoring, remote study management and data management and analysis services in the following areas:

• Lower respiratory tract infection (LRTI)
• Bacterial sinusitis
• Bacterial vaginosis
• Chronic bronchitis
• Fungal infections
• Hepatitis A, B, C
• Human immunodeficiency virus(HIV)
• Influenza vaccine
• Malaria
• Pediatric pneumonia
• Skin and soft tissue infection
• Urinary tract infection (UTI)

 

 

Auto-Immune Diseases:

• Crohn’s disease
• Osteoarthritis
• Rheumatoid arthritis

 

 

 

 

 

 

 

 

Internal Medicine:

In difficult-to-find patient population studies, Criterium works with clients to over-enroll sites and control costs using technology to manage data from those sites that are actively screening and enrolling patients into the study.

• Crohn’s disease
• Osteoarthritis
• Rheumatoid arthritis
• Ulcerative colitis

 

 

 

 

 

 

 

Media:

• Capsules
• Creams
• Gels
• Patches
• Solutions
• Sterile Solutions
• Tablets

 

 

 

 

Medical Devices:

• Artificial skin for wounds and ulcers
• Bladder retraining device
• Bladder warming device
• Bulking agent for wrinkles
• Bulking agents for incontinence
• Diagnostic equipment evaluation and validation
• Lens replacement for cataracts
• Nebulizers
• Stents
• Transcutaneous nerve stimulators

 

 

 

 

Metabolic Diseases:

• Diabetes
• Hypercholesterolemia

 

 

 

 

 

 

Oncology:

• Breast cancer
• Pancreatic cancer
• Prostate cancer

 

 

 

 

Ophthalmology:

• Anti-allergy therapy for allergic conjunctivitis
• Clinical trial management support for open angle glaucoma clinical trial
• Collagen glaucoma drainage device for surgical treatment of open angle glaucoma
• FDA/IDE clinical investigation for intraocular lens, Phase I-II, multi-center trial in Europe
• ICL for correction of myopia and hyperopia
• Immuno-therapy for prevention of secondary cataracts
• Intraocular lens (IOL) for aphakic patients and sodium hyaluronate viscoelastic
• Lens replacement for cataracts
• Multi-center international investigation conducted in Europe and the US, Phase II and III
• Regulatory support for a late stage age-related macular degeneration (ADM) clinical trial
• US regulatory agent in support of 510k submission for glaucoma diagnostic device

 

Pain Management:

Criterium senior management has years of experience designing, conducting, managing and summarizing studies of agents administered for acute and chronic pain including arthritis, surgical pain and cancer pain. Using our TeleDiary™ IVR services, we collect data directly from patients who evaluate their absolute pain, changes in pain and pain relief when treated with narcotic or non-narcotic analgesics, administered orally, by injection or transdermally. We have provided data gathered in this way for NDAs and Supplemental NDAs. Areas in which Criterium has expertise include:

• Acute and Chronic Pain
• Malignant and Non-Malignant Pain
• Headache pain
• Migraine
• Transcutaneous nerve stimulation

Respiratory:

Criterium has managed Respiratory drug studies including beta-agonists and steroid formulations via all routes of administration (inhalation, oral, and injectable). Using the TeleDiary™ patients are able to report pulmonary function information collected from portable electronic devices. Criterium has conducted studies in the following areas:

• Mild, moderate, and severe pediatric and adult asthma
• Community acquired pneumonia
• Chronic obstructive pulmonary disease (COPD)
• Cystic fibrosis
• Respiratory tract infections.

 

 

 

Urology:

Criterium has conducted IND and IDE studies in various urologic indications with sites in USA, Canada, Brazil, Austria, Britain, Germany, South Korea, Singapore, Philippines, Malaysia and Thailand. Using our technology, Criterium has been able to manage the financial needs of small clients and regional differences in costs. These studies have resulted in drug and device approvals in the USA and other regions of the world.

• Erectile Dysfunction
• Stents
• Stress Incontinence
• Training Devices
• Urge incontinence
• Urinary Incontinence

 

 

 

Women’s Studies:

Criterium’s technology is ideally adapted for conducting large studies in women’s health in Phase III and Phase IV. Using our technology tools, we have contributed pivotal data to NDAs, supplemental NDAs and ANDAs. The areas in which Criterium has experience are:

• Bacterial Vaginosis
• Bleeding Disorders
• Fungal Infection
• Hormone Replacement Therapy
• Oral contraception
• Premature labor and delivery
• Stress and Urge Urinary Incontinence

 

 

 

Therapeutic Expertise

Allergy: Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis, Bacterial Sinusitis, Allergic Conjunctivitis	Cardiovascular: Congestive Heart Failure (CHF), Hypertension, Arrhythmias, Mortality, Angina, Atherosclerosis, post-CABG
CNS: Alzheimer’s Disease, Anxiety, Depression, Multiple Sclerosis, Chronic Fatigue Syndrome	Dermatology: Cosmetic, Retinoic Acid, Decubitus Ulcer, Artificial Skin
Gastroenterology: Crohn’s Disease, Duodenal Ulcer, Gastric Ulcer, Esophagitis, Fabry Disease	HIV/Infectious Disease: Human Immunodeficiency Virus (HIV), Acquired Immunodeficiency Disease Syndrome (AIDS), Lower Respiratory Tract Infection (LRTI), Pediatric Pneumonia, Chronic Bronchitis, Skin and Soft Tissue Infection, Urinary Tract Infection (UTI), Hepatitis A, B, and C, Bacterial Vaginosis, Malaria, Fungal Infections
Immunology: Auto-Immune Disease (Rheumatoid Arthritis, Osteoarthritis, Crohn’s Disease)	Internal Medicine: Chrohn’s Disease, Osteoarthritis, Rheumatoid Arthritis, Ulcerative colitis
Medical Devices: Stents, Bulking Agents for Incontinence, Bladder Retraining Device, Bladder Warming Device, Artificial Skin for Wounds and Ulcers, Nebulizers, Lens Replacement for Cataracts, Diagnostic Equipment Evaluation and Validation, Bulking Agent for Wrinkles, Transcutaneous Nerve Stimulators	Metabolic Disease: Diabetes, Hypercholesterolemia
	Hematology: Hemophilia, Von Willebrand’s Disease, Plasmapheresis
Oncology: Breast, Renal, Pituitary	Ophthalmology: Lens replacement and Immunosuppressive therapy for prevention of secondary cataracts
Pain Management: Narcotic, Non-narcotic, Acute and Chronic Pain, Malignant and Non-Malignant Pain, Headache pain, Migraine, Transcutaneous Nerve Stimulation	Respiratory: Mild, moderate, and severe pediatric and adult asthma; Community acquired pneumonia, Chronic obstructive pulmonary disease(COPD), Cystic Fibrosis, Respiratory tract infections.
Transplantation: Kidney	Urology: Urinary Incontinence, Urge incontinence, Stress Incontinence, Stents, Erectile Dysfunction, Chronic Renal Failure
Vaccines: Human Immunodeficiency Virus (HIV), Influenza	Women’s Studies: Premature labor and delivery, Oral contraception, Hormone Replacement Therapy, Bleeding disorders, Stress and Urinary Urge Incontinence, Osteoporosis, In Vitro Fertilization
Delivery: Inhalation, Intranasal, Buccal, Transdermal, Intravenous, Intrathecal, Oral	Media: Tablets, Capsules, Solutions, Sterile Solutions, Gels, Creams, Patches