PRINEOS team has more than 25 years of scientific, medical and biostatistical know-how, as well as sound clinical and regulatory experience encompassing more than 1100 clinical studies on drugs, medical and diagnostic devices, food supplements, nutraceuticals and dermocosmetics across many therapeutic areas.
Our strongest expertise lies in:
Cancer is the second leading cause of death globally, accounting for nearly 10 million deaths in 2020. Lung, prostate, colorectal, stomach and liver cancers are the most common types of solid tumors in men, while breast, colorectal, lung, cervical and thyroid cancers are the most common among women. Cancer burden continues to grow globally, exerting tremendous physical, emotional and financial strain on individuals, families, communities and health systems.
About 28% of our team’s overall experience concerns solid tumors, primarily interventional and observational clinical trials (from phase I to phase IV) studying various therapeutic interventions, including drugs, Advanced Therapy Medicinal Products (ATMPs), immunotherapies and medical devices, for (advanced/ metastatic):
๏ Breast cancer
๏ Lung cancer
๏ Gastrointestinal, liver and pancreatic cancers
๏ Genitourinary and renal cancers
๏ Skin tumors
๏ Brain tumors
๏ Prostate cancer
Hematological diseases are pathological conditions primarily affecting the blood or blood-producing organs. Common hematologic disorders include anemia and iron deficiency, bleeding disorders such as hemophilia, blood clots and blood cancers such as leukemia, lymphoma and myeloma. Hematology-related diseases contribute substantially to global mortality and morbidity.
Approximately 15% of PRINEOS experts’ overall expertise and know-how lies in the hematology/onco-hematology field. Our experts have been involved in the design and conduct of numerous interventional (mostly phase II and III) and observational clinical trials in adults and children on novel drugs and ATMPs for several indications, including but not limited to:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ Transfusion hemosiderosis
๏ Acute/chronic myeloid leukemia
๏ Chronic lymphocytic leukemia
๏ Hodgkin’s and non-Hodgkin’s lymphoma
๏ Acute lymphoblastic leukemia
๏ Multiple myeloma
๏ Primary myelofibrosis
๏ Myelodysplastic syndrome
๏ Beta-thalassemia
๏ Graft versus host disease
๏ Hemophilia A and B
๏ Immune thrombocytopenia
๏ Polycythemia vera
๏ Von Willebrand disease
Neuropsychiatric disorders, namely neurological conditions (i.e. any condition that affects the brain, spinal cord and/or nerves) and mental disorders, are the number one cause of disability in the world. As the global population is growing and ageing, the prevalence and burden of neuropsychiatric disorders continue to increase with significant impacts on health and major social, human rights and economic consequences in all countries of the world. Among neurological disorders, cerebrovascular diseases, Alzheimer’s Disease and other dementias, migraine, epilepsy and meningitis are the most burdensome.
Approximately 8% of our professionals’ overall experience regards neuropsychiatric disorders. Our experts have worked on various interventional (phase II and III) and observational clinical studies on drugs, ATMPs and medical devices in patients suffering from, among others:
๏ Multiple sclerosis
๏ Parkinson’s disease
๏ Alzheimer’s disease
๏ Epilepsy
๏ Migraine
๏ Chronic/neuropathic pain
๏ Schizophrenia
๏ Depression
๏ Vascular dementia
๏ Opioid abuse
Cardiovascular diseases are a group of disorders of the heart and blood vessels that includes hypertension, coronary heart disease, cerebrovascular disease, peripheral vascular disease, heart failure, heart valve disease and cardiomyopathies. Cardiovascular diseases are the first leading cause of death worldwide and a major cause of disability.
About 6% of the overall experience of our group of experts is related to cardiovascular diseases, in particular interventional and observational clinical studies (from phase I to phase IV) investigating therapeutics ranging from drugs and ATMPs to medical devices and nutraceuticals for the treatment or prevention of, among others:
๏ Heart failure
๏ Hypertension
๏ Myocardial infarction
๏ Coronary artery disease
๏ Deep vein thrombosis
๏ Ischemic stroke
๏ Left ventricular dysfunction/hypertrophy
Rheumatic and musculoskeletal diseases (RMDs), i.e. a diverse group of diseases commonly affecting the joints, and in some cases the muscles, other tissues and internal organs, are a major cause of disability. Around one out of four citizens in Europe suffer from a chronic RMD. Most common RMDs include low back pain, osteoarthritis, osteoporosis, fibromyalgia, rheumatoid arthritis and gout.
About 6% of PRINEOS team’s overall experience concerns RMDs. PRINEOS experts have extensively contributed to the design and development of numerous interventional and observational clinical studies (from phase I to phase IV) on drugs, ATMPs and medical devices in patients with, among others:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ Systemic-onset juvenile idiopathic arthritis
๏ Rheumatoid arthritis
๏ Psoriatic arthritis
๏ Osteoarthritis
๏ Osteoporosis
๏ Ankylosing spondylitis
๏ Axial spondylarthritis
๏ Inclusion-body myositis
๏ Polymyalgia rheumatica
Endocrine and metabolic diseases span a vast range of conditions. Among those, diabetes is the most common disorder and its prevalence has been rising, with a greater rapidity in low- and middle-income countries. Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and lower limb amputation, and one of the world’s top ten leading cause of death.
Nearly 6% of the overall experience of our professionals lies in the field of endocrinology and metabolic diseases, having supported the design and management of numerous interventional and observational clinical studies (mostly phase II, III and IV) on drugs, medical devices and food supplements for several indications, including but not limited to:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ Type 2 diabetes
๏ Metabolic syndrome
๏ Obesity
๏ Dyslipidemia
๏ Cushing’s disease
๏ Acromegaly
๏ Growth hormone deficiency
๏ Primary hyperaldosteronism
Some of the most common Chronic Respiratory Diseases (CRDs) (i.e. diseases of the airways and other structures of the lung) are chronic obstructive pulmonary disease (COPD), asthma, occupational lung diseases and pulmonary hypertension. COPD is the third leading cause of death worldwide, with the majority of these deaths occurring in low- and middle-income countries. Asthma is a major noncommunicable disease, affecting both children and adults.
About 5% of PRINEOS team’s overall experience regards respiratory diseases. PRINEOS experts played an integral role in the design, development and analysis of several interventional and observational clinical trials (mainly phase II, III and IV) on various interventions, including drugs and food supplements, in adult and pediatric patients with, among others:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ COPD
๏ Asthma
๏ Idiopathic pulmonary fibrosis
๏ Pulmonary arterial hypertension
๏ Acute respiratory distress syndrome
๏ Allergic rhinoconjunctivitis
๏ Lymphangioleiomyomatosis
Infectious diseases are disorders caused by pathogenic microorganisms, such as bacteria, viruses, fungi or parasites. No doubt nowadays COVID-19 is the first serious infectious disease that comes to mind. Even not considering the recent COVID-19 pandemic, infectious diseases are one of the leading causes of death worldwide, particularly in low-income countries and especially in young children. Moreover, antibiotic resistance is one of the greatest public health challenges of our times.
Approximately 4% of the overall experience of professionals at PRINEOS encompasses a wide variety of infectious diseases, including but not limited to:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ COVID-19
๏ Meningococcal B meningitis
๏ Onychomycosis
๏ HIV/AIDS
๏ Herpes zoster
๏ Malaria
๏ Respiratory tract infections
๏ Bacterial rhinosinusitis
๏ Otitis media and externa
๏ Urinary tract infections
๏ Influenza
๏ Community-acquired pneumonia
๏ Small intestinal bacterial overgrowth
๏ Bacterial conjunctivitis
Vision impairment is a common problem worldwide. Ageing increases the risk of eye diseases that can lead to eyesight impairments ranging from slight vision abnormalities to complete blindness. Major causes of vision impairment are refractive disorders, cataracts, age-related macular degeneration, glaucoma, and diabetic retinopathy.
About 4% of PRINEOS team’s overall experience lies in the field of ophthalmology, having worked on numerous interventional and observational clinical trials (from phase I to phase IV) involving drugs/ATMPs, medical devices and food supplements in adult and pediatric patients with, among others:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ Age-related macular degeneration (AMD)
๏ Choroidal neovascularization
๏ Diabetic macular edema and retinopathy
๏ Glaucoma
๏ Cataract
๏ Dry eye syndrome
๏ Retinitis pigmentosa
๏ Retinopathy of prematurity
๏ Blepharitis
๏ Panuveitis in Beh et's disease
Gastrointestinal and liver diseases have considerable prevalence rate and burden, being responsible for around one million deaths each year across Europe across all ages. Cirrhosis, which is commonly caused by alcohol, non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) and viral hepatitis, and other chronic liver diseases are a major cause of morbidity and mortality globally. Gastric diseases range in prevalence and severity, and include a variety of widespread and burdensome chronic disorders such as irritable bowel syndrome (IBS).
About 4% of our team’s overall experience lies in the gastroenterology and hepatology field. Our group of experts has contributed to the design and development of several interventional and observational clinical studies (mainly phase II, III and IV) evaluating drugs, medical devices and nutraceuticals for several gastrointestinal and liver diseases, including but not limited to:
๏ Chronic hepatitis B and C
๏ IBS
๏ Crohn’s disease
๏ Chronic constipation
๏ Diverticular disease
๏ NASH
๏ Ulcerative colitis
๏ Hepatic fibrosis
๏ Infantile colic
Almost half of people in Europe have a skin problem or disease. The majority of skin conditions are not life-threatening; however, many can be severe and disfiguring enough to devastate a patient's quality of life. Indeed, dermatological disorders continue to be the 4th leading cause of non-fatal disease burden worldwide.
About 3% of PRINEOS team’s overall experience concerns dermatological disorders, having substantially contributed to the design and conduct of several interventional and observational clinical trials (mainly phase II, III and IV) on novel drugs in patients with, among others:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ Psoriasis
๏ Hidradenitis suppurativa
๏ Atopic dermatitis
๏ Rosacea
๏ Cutaneous lupus erythematosus
๏ Chronic palmoplantar pustular psoriasis
๏ Chronic spontaneous urticaria
Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared to the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens. About 80 percent of these rare disorders are of genetic origin, about half affect children, many are fatal, and very few have cures. The subject of rare diseases was noticed as a serious health, social and economic problem in the European Union countries and in the world.
Nearly 2% of the overall experience of PRINEOS experts regards genetic diseases. Professionals at PRINEOS have provided extensive support designing, conducting and analyzing several interventional and observational clinical trials (from phase I to phase IV) on novel drugs in patients with a wide variety of rare genetic diseases, including but not limited to:
๏ Rare or orphan diseases are serious, often chronic and progressive diseases that affect a small number of people compared the general population. Any disease affecting fewer than 5 people in 10,000 in Europe is considered rare. There are more than 6,000 rare diseases and, overall, rare diseases may affect 30 million European Union citizens.
๏ Fragile X syndrome
๏ Cystic fibrosis
๏ Spinal muscular atrophy
๏ Systemic sclerosis
๏ Tuberous sclerosis complex
๏ Becker Muscular Dystrophy
๏ Sickle cell disease
๏ Down syndrome
๏ Tumor necrosis factor receptor associated periodic syndrome
๏ Neonatal onset multisystem inflammatory disease
About 7% of our overall experience encompasses numerous clinical trials across other therapeutic areas, such as immunology, nephrology, urology, gynecology and diagnostics.