Trial Experience

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Experience in Numbers

We pride ourselves on our quality of work, there is no substitute for experience as the numbers show below.

50
Drugs
Number of diifferent drugs
300+
Studies
Total number of Studies to date
40
Trials
Number of Studies per year
35
Sponsors
Number of sponsors to date
Breakdown by phase - Some examples of our experience below:
Phase I Studies
6+
Trials
Immunology
15+
Trials
Oncology
10+
Trials
Respiratory
4+
Trials
Skin
Phase II Studies
6
trials
Neurology
10+
Trials
Oncology
8+
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
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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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