Therapeutic Experience

With over 35 years of experience, Datapharm has proudly managed clinical research across all phases and most therapeutic areas. Datapharm has relationships with some of the best clinical trial Investigators and sites in Australia and New Zealand.

Therapeutic Areas of Experience:

gastroenterology
haematology and immunology
mental health
musculoskeletal
neurology
oncology
ophthalmology
pain
respiratory
reproductive technology
AIDS/HIV
alternate therapies
anti-infectives
cystic fibrosis
cardiovascular
diabetes
dermatology
devices
diagnostics
first-in-humans

Respiratory Research

Datapharm recently completed an Australia wide multi-centre clinical trial in COPD, recruiting over 300 patients in a limited seasonal timeline. Datapharm is currently consolidating its Respiratory Clinical Trials Network for Australia & New Zealand to cover research into Asthma, COPD, CF, IPF, Bronchiectasis, Emphysema, alpha 1-antitrypsin deficiency and flu vaccines. To find out more about this capability contact us today.

Pain research

Datapharm managed two phase I pharmacokinetic studies of analgesic products using healthy volunteers and conducted several studies of treatments for chronic pain including back pain, sciatica, pain due to cancer and the neuropathic pain of diabetes. One large phase III study investigated pain relief for subjects with post-herpetic neuralgia, plus migraine and chronic daily headache with some of Australia’s leading pain management experts. Datapharm is building its Clinical Trials Network for Australia and New Zealand targeting Central Nervous System (CNS) clinical research.

Oncology Research

Datapharm has conducted a number of first-in-man (Phase 0) studies from the first gene therapy study referred to GTRAP in the mid 90s, targeted intra-arterial and delivery vehicle studies and most recently intratumoural injections of a DNAzyme. These new and innovative treatment strategies needed careful planning and implementation to see each project to successful completion.

Datapharm has experience in Phase 1/II studies of prostate cancer therapies, melanoma treatments, haematological malignancies and glioblastoma multiforme. These are typically dose finding studies often requiring a PK component. Datapharm has assisted with Phase II clinical studies of breast and ovarian cancer, cancers of bowel and blood and a large international Phase III clinical trial using antisense material in the treatment of CLL. This was an important and successful study allowing our client to proceed to final registration of the product.

Datapharm also has Phase IV (post-marketing) oncology experience, having conducted a long-running study into the use of isoflavones to treat prostate cancer.

Currently Datapharm is building its clinical trial network of Melanoma specialists for both early and late phase clinical trials in Australia and New Zealand.

Dermatology Research

Datapharm has customised early phase studies into the safety of dermal fillers for cosmetic enhancements and a pilot study into a skin assessment instrument for understanding perception of changes due to aging. Datapharm has experience in multiple phase II and III studies of systemic sun protection products adding to our experience of cosmetic dermatology studies, along with phase IV eyelash enhancement study for which we provided statistical and medical writing services.

There’ve been phase II and IV studies into atopic eczema treatments and a phase II/III study using a systemic acne treatment. We were pleased to be part of studies of psoriasis in phase II and phase IV of product development and we conducted a phase II study in the very disfiguring and difficult to treat skin disease, vitiligo. Wound healing, while not a disease of skin alone, has been the target of three very different early phase studies of natural products and laser therapy.

Cardiovascular Research