Experience in Numbers
We pride ourselves on our quality of work, there is no substitute for experience as the numbers show below.
55
Drugs
Number of different drugs
450
+
Studies
Total number of Studies to date
40
Trials
Number of Studies per year
38
Sponsors
Number of sponsors to date
Breakdown by phase - Some examples of our experience below:
Phase I Studies
6
+
Trials
Immunology
35
+
Trials
Oncology
15
+
Trials
Respiratory
4
+
Trials
Skin
Phase II Studies
6
trials
Neurology
15
+
Trials
Oncology
10
+
Trials
Respiratory
4
trials
Skin
Phase III Studies
10
+
Trials
Immunology, Respiratory, Oncology, Skin
Other Studies
10
+
Trials
Phase IV
15
+
Trials
Observational
12
+
Trials
Cosmetics
8
+
Trials
Animal
Breakdown by innovative statistical method
30
+
Trials
Bayesian inference
30
+
Trials
Adaptive dose escalation in phase I
40
+
Trials
Adaptive dose-finding
20
+
Trials
Group sequential methods
10
+
Trials
Adaptive sample size re-estimation
8
+
Trials
Population enrichment trials
14
+
Trials
Seamless studies
4
+
Trials
Population PK/PD
Experience by Therapeutic Area
- Oncology (pancreatic, Cutaneous Squamous Cell Carcinoma, solid tumors, prostate cancer, acute myeloid leukemia, hematological malignancies
- Nervous system (pain, migraine, epilepsy, parkinson, alzheimer, depression, anxiety, schizophrenia, narcolepsy, insomnia, abuse potential, neurogenic detrusor overactivity, shift work disorder, multiple sclerosis)
- Skin (acne, psoriasis, actinic keratosis, dandruff, UV pigmentation, hidradenitis suppurativa
- Opthalmology (macular dystrophy, cataract surgery, uveitis, age-related macular degeneration, multifocal choroiditis, diabetic macular edema, retinal vein occlusions, hotorefractive keratectomy)
- Virology (malaria, influenza, human cytomegalovirus)
- Cardiovascular (anemia, hypertension, systolic heart failure, peripheral artery disease, paroxysmal nocturnal hemoglobinuria, pulmonary arterial hypertension
- Metabolic (diabetes, cholesterol, obesity, non-alcoholic steatohepatitis)
- Anti-infectives (anti-biotics, sepsis)
- Respiratory (asthma, chronic obstructive pulmonary disease, Pulmonary Sarcoidosis, allergic rhinitis, grass allergy, mechanical ventilation)
- Immunology (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, Crohn’s disease)
- Urology/Gynecology (Distal Renal Tubular Acidosis, cystinuria , vulvodynia, ulcerative colitis, hypophosphatasia, kidney disease, renal impairment, external genital warts, kidney transplant, polycystic ovary syndrome, nephropathy
- Ear, nose, throat (tinnitus)
- Endocrine (acromegaly, NET, diabetes, insulin resistance)
- Muscle and bones (sarcopenia, osteoporosis, Inclusion Body Myositis, spinal muscular atrophy, autologous chondrocyte implantation, cartilage lesions, pigmented villonodular synovitis, Duchenne muscular dystrophy
Regulatory Experience
- EMA and FDA
- Regulatory documents preparation/review
- Meeting attendance: scientific advises, POCD, End of Phase II, NDA, Type B and C meetings
- Area : anti infectives, neurosciences, endocrinology, ophthalmology, urology, virology
Request for proposal
We will be pleased to hear about your trial project and provide you with a tailored-made, cost effective biometrics solution.
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