Trial Experience

We are great at what we do!

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Data management and organisation

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
350
+
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
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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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