TherapeUtic experience
ARIRDMSCRO, founder member has a wealth of therapeutic area experience. He has supported over 1000 studies in Clinical Operations and Project Management across all major therapeutic areas including oncology, cardiovascular, CNS, endocrinology, dermatology, ophthalmology, orthopedics, vaccines, pediatrics, elderly studies, wound healing and neurology. Therapeutic Areas which we have clinical trial experience.
Cardiovascular/Metabolic
ARIRDMSCRO, founder member has worked in a number of different indications in the cardiovascular and metabolic arena including Non valvular Atrial Fibrillation (NVAF), stroke, coronary heart disease, acute coronary syndromes, and heart failure. We have provided assistance on multi-center, multinational trials investigating the effect of exercise in subjects with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease.
Neurosciences
ARIRDMSCRO, founder member has worked in a number of different indications in the neurosciences area, including Major Depressive Disorder, Alzheimer’s Disease, Schizophrenia, Pain (acute pain, arthritic pain, diabetic peripheral neuropathic pain, etc.). Challenges in the neurosciences area include high placebo response in some indications, monitoring of suicidal ideation and behavior, assessment of symptoms that emerge on discontinuation of treatment, and carrying out studies in subjects with significant cognitive impairment.
CNS
ARIRDMSCRO, founding member has supported many studies over the years across a diverse range of therapeutic indications in all phases of clinical development. Project management services have been provided to many clinical studies in the Central Nervous System therapeutic area, such as Infectious Diseases studies across Phases I to IV.
Oncology
ARIRDMSCRO, founding member 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 tumor response (lesion size and other methods of tumor measurement), progression-free survival, and overall survival, and we have undertaken studies modelling tumor growth.
Dermatology
ARIRDMSCRO, founding member has worked in a number of studies in the indications of Acne Vulgaris, Psoriasis Lesions, and complicated skin and skin structure infections. Endpoints include numbers of different types of lesions/pustules.
Ophthalmology
ARIRDMSCRO, founding member has worked in a number of different indications in the ophthalmology area including 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, Intraocular Pressure, Color Vision Scales, quality of life (QoL) data, and 1000 person-years at risk.
Endocrinology & Metabolic Disease
ARIRDMSCRO, founding member has supported many studies in Endocrinology over the last few years. Our expertise includes, but is not limited to, provision of effective project management and clinical operations for diabetes and growth hormone deficiency projects spanning all phases of clinical development.
Pain Management
ARIRDMSCRO, founding member has successfully worked on a number of multi-center, 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 and surgery).
Gastroenterology
ARIRDMSCRO, founding member has worked in a number of studies in the indications of Crohn’s disease, Ulcerative Colitis, Ulcerative Proctitis and IBD.
Rare Diseases
ARIRDMSCRO, founding member has worked on various rare disease studies and have recently supported an orphan drug application by providing both project management and clinical operations activities to a study investigating the safety and efficacy of recombinant molecules. In estimating prevalence for an orphan drug application in head and neck cancers.
Haematology
Over the last few years, ARIRDMSCRO, founding member has worked on multiple studies in Hematology covering studies on Phase III and IV.
Respiratory & Immuno-inflammatory
ARIRDMSCRO founding member 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).
Anti-infectives
ARIRDMSCRO, founding member has worked on a number of anti-infectives in the following indications: Volvo-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.
Vaccine & Virology
ARIRDMSCRO, founding member has worked on a number of vaccine studies for different indications, including Falciparum malaria for a large company, and numerous other immunogenicity studies, in addition to vaccination studies in veterinary medicine (including for bovine respiratory diseases and bovine immunization). 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.
Infectious Diseases
Over a period of 19 years spanning all clinical operation functions, we have successfully worked on numerous Infectious Diseases (including Phase III studies in this area). Example indications include; TB, MRSA, MDRTB, IBD, and Vaccines. 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.
Muscoskeletal, Rheumatology, & Osteology
ARIRDMSCRO, founding member has successfully worked in multiple studies in Muscoskeletal Rheumatology & Osteology, covering indications such as Multiple Sclerosis etc.
Nephrology, Renal, & Urology
Over the last few years, ARIRDMSCRO, founding member has supported a number of studies with regards to Nephrology, Renal, & Urology. Specific indications such as Chronic Kidney disease, Anemia, and Benign Prostatic Hyperplasia have been covered during these studies. The studies worked on covered multiple phase studies.
