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Therapeutic Area Experience in Clinical Trials

Quanticate has a wealth of therapeutic area experience. We have supported over 1000 studies in biostatistics, statistical programming, clinical data management, pharmacovigilance, and medical writing across all major therapeutic areas.

Therapeutic Areas which we have clinical trial experience:

Cardiovascular/Metabolic
Quanticate has worked in a number of different indications in the cardiovascular and metabolic arena including disseminated intravascular coagulation (DIC), stroke, coronary heart disease, acute coronary syndromes, and heart failure. We have provided assistance on multi-centre, multinational trials investigating the effect of exercise in subjects with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease in addition to extensive experience supporting a Biologic License Application (BLA).

CNS
Quanticate has supported many studies over the last 10 years across a diverse range of therapeutic indications in all phases of clinical development. Biometrics services have been provided to many clinical studies in the Central Nervous System therapeutic area, such as Alzheimer's, Parkinson's, and Infectious Diseases studies across Phases I to III.

Dermatology
Quanticate has worked in a number of studies in the indications of Acne, Dermatitis, Atopic Eczema, Acne Vulgaris, Psoriasis Lesions, and Lipodystrophy. Endpoints include numbers of different types of lesions/pustules.

Endocrinology & Metabolic Disease
Quanticate has supported many studies in Endocrinology over the last 3 years.  Our expertise includes, but is not limited to, provision of biostatistical and programming, clinical data management, and medical writing services for diabetes and growth hormone deficiency projects spanning all phases of clinical development.

Gastroenterology
Quanticate has worked in a number of studies in the indications of Crohn’s disease, Ulcerative Colitis and constipation.

Haematology
Over the last three years, Quanticate has worked on multiple studies in Haematology covering studies on Phase I and IV.

Anti-infectives
Quanticate has worked on a number of anti-infectives in the following indications: sinusitis, impetigo, vulvo-vaginal candidiasis, and malaria prevention. In addition, we have supported a client across 3 Phase II/III studies for the use of antibiotics in combating malaria in emerging markets. We are familiar with a range of endpoints, including quality of life (QoL) data, parasite-replication count, immunological endpoints (such as interleukins) and antibodies.

Infectious Diseases
Over a period of 10 years spanning all biometric functions, we have successfully worked on numerous Infectious Diseases (including Phase III studies in this area). Example indications include; Cholera, influenza, and Hepatitis. In addition, we have a long-established history of supporting our customers on HIV studies across a range of compounds and indications. We are familiar with a range of endpoints, including quality of life (QoL) data, viral-load, clusters of differentiation 4 (CD4) counts, and survival analysis. We have experience in detailed evaluation of the impact of genetic variants on safety and efficacy endpoints.

Muscoskeletal, Rheumatology, & Osteology
Quanticate has successfully worked in multiple studies in Muscoskeletal Rheumatology & Osteology, covering indications such as Multiple Sclerosis and Duchenne Muscular Dystrophy.

Nephrology, Renal, & Urology
Over the last 3 years, Quanticate has supported a number of studies with regards to Nephrology, Renal, & Urology. Specific indications such as Chronic Kidney disease, Anaemia, and Benign Prostatic Hyperplasia have been covered during these studies. The studies worked on covered multiple phase studies.

    

Neurosciences
Quanticate has worked in a number of different indications in the neurosciences area, including Major Depressive Disorder, Attention-Deficit-Hyperactivity-Disorder, Alzheimer's Disease, Parkinson's Disease, Huntingdon Disease, Schizophrenia, Pain (acute pain, arthritic pain, diabetic peripheral neuropathic pain, post-herpetic neuralgia, fibromyalgia), restless legs syndrome, and migraine. Challenges in the neurosciences area include high placebo response in some indications, monitoring of suicidal ideation and behaviour, assessment of symptoms that emerge on discontinuation of treatment, and carrying out studies in subjects with significant cognitive impairment.

Obstetrics/Gynaecology
Over the last 3 years, Quanticate has worked on multiple Gynaecology studies with reference to Ovulation, Contraception, and Anovulation. These studies have successfully worked on during Phase IV.

Oncology
Quanticate has worked in a number of different indications in the oncology area indicating squamous cell cancer (various locations) and solid organ cancers including prostate. We are familiar with many of the key endpoints that arise including assessing tumour response (lesion size and other methods of tumour measurement), progression-free survival, and overall survival, and we have undertaken studies modelling tumour growth.

Ophthalmology
Quanticate has worked in a number of different indications in the ophthalmology area including age-related macular degeneration (AMD), diabetic macular edema, and medical devices including the application of contact lenses and intraocular lenses. We are familiar with many of the key endpoints that arise including Visual Acuity (Snellen), Intraocular Pressure, Colour Vision Scales, quality of life (QoL) data, and 1000 person-years at risk.

Pain Management
Quanticate has successfully worked on a number of multi-centre, flexible dose, and multinational studies across the pain therapeutic area (e.g. post-surgical pain after inguinal hernia repair, neuropathic pain associated with HIV neuropathy, and chronic central neuropathic pain after spinal cord injury).

Rare Diseases
Quanticate has worked on various rare disease studies and have recently supported an orphan drug application by providing both statistical and medical writing activities to a study investigating the safety and efficacy of recombinant human C1 inhibitor, for the treatment of acute attacks in patients with hereditary angioedema. In addition, we have experience of estimating prevalence for an orphan drug application in Parkinson's disease, and head and neck cancers.

Respiratory & Immuno-inflammatory
Quanticate has worked in a number of different indications in the respiratory and immuno-inflammatory disease area including allergic rhinitis, asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, psoriasis, ankylosing spondylitis, and transplantation (renal and liver). Quanticate supported a large pharmaceutical company on a study of COPD. This involved exploratory statistical modelling of exacerbations and economic costs.

Vaccine & Virology
Quanticate has worked on a number of vaccine studies for different indications, including Falciparum malaria for a large pharmaceutical company, and numerous other immunogenicity studies, in addition to vaccination studies in veterinary medicine (including for bovine respiratory diseases, feline leukaemia, feline influenza, and porcine boar taint). Endpoints included antibody response at primary or booster vaccination and clinical signs. Some of this work involved assessing combinations of multiple vaccines which had already been proven efficacious in monovalent or bivalent form, and combining these into trivalent or pentavalent forms.

 


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"Thank you so much!  It’s so nice to get this study crossed off of our list! We really appreciate everything that Quanticate has done for our study.  We look forward to working with you all in the future!"
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