Early clinical-stage US dermatology biotech Botanix Pharmaceuticals was keen to accelerate the clinical development of its lead acne product and...
Experience
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With more than 1,100 projects completed across most therapeutic areas, Novotech has a world of experience. And it’s that experience that sets us apart, making us one of the leading midsize clinical research organizations – not just in the Asia-Pacific region, but in the world.
Case Studies
Here are just a few examples of why we have a reputation as the leading regional CRO in the Asia-Pacific.
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 When a global pharmaceutical company and its CRO partner required assistance recruiting for a phase III trial investigating a wet AMD product,... |
 As part of its global phase III trial, a US biotechnology company required the inclusion of specific Asia Pacific countries due to the high... |
 Early clinical-stage US biotech DiaMedica engaged Novotech to help it take advantage of Australia’s supportive early stage research... |
 When South Korean oncology biotechnology company PharmAbcine completed a successful domestic phase I study for the... |
 In support of a global registry study, the Thrombosis Research Institute (TRI) engaged Novotech to monitor a... |
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Our CRO Services
| Clinical Trials | Audits |
| Biostatistics | Medical Services |
| Data Management | Commercialization |
| Regulatory Affairs | Site Management (SMO) |
Many biotechnology companies come to Australia to conduct early phase clinical trials and take advantage of straightforward regulatory streams and the lucrative R&D cash refund scheme. Biotechnology companies then often look at locations in Asia, such as South Korea, Thailand and China to tap into their huge treatment-naïve patient populations for their later phase clinical research.
Novotech is recognized as the Asia-Pacific full-service contract research organization (CRO). Novotech has been instrumental in the success of over 1,000 clinical trial projects of Biotechnology companies in key areas such as Immuno-Oncology, Infectious diseases, Vaccines and Orphan and rare diseases.
Novotech has provided CRO services across a broad range of Oncology, hematology, Infectious diseases, Vaccines and Orphan indications and treatment modalities.
Oncology-Hematology CRO services
Biotechnology companies are facing increased challenges around participant recruitment and retention, lengthy timeframes and relatively high costs.
For these reasons we observed a fast-growing interest from biotechnology companies to include the Asia-Pacific region for their Oncology drug development. The yearly activity growth of biotechnology companies in Oncology and Immuno-Oncology was estimated at around 40% in the Asia-Pacific region between 2016 and 2018.
About half of Novotech’s projects are in Oncology and Immuno-Oncology. Novotech has built teams with deep expertise in Oncology and Immuno-Oncology and strong connections with Oncology key opinion leaders and sites in the Asia-Pacific region.
Infectious diseases and Vaccines CRO services
Novotech has completed over 150 projects in Infectious diseases and Vaccines. Many biotechnology companies look at the Asia-Pacific region for their trials in Infectious diseases and Vaccines due to the high prevalence of diseases such as Hepatitis (Hepatitis B, Hepatitis C), HIV and Influenza.
Orphan and rare disease drugs CRO services
Over the last years, we saw a major global effort in the clinical development of Orphan drugs. Asian countries have been implementing legal frameworks similar to the Orphan Drug Act used in the US, encouraging clinical trials in many locations including South Korea, Taiwan, Singapore and The Philippines.
Areas of Expertise
Our extensive experience as a clinical research organization across major therapeutic areas include:
| Analgesia - pain management | Infectious Diseases - genital herpes, influenza, pneumonia, sepsis |
| Anti-infectives - antivirals, novel antibiotics, vaccines | Gastroenterology - cirrhosis, Crohn's disease, hemorrhoids, IBD |
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Cardiovascular - acute coronary syndromes, CAD, CHF, chronic angina |
Oncology - a range of indications including: breast, colorectal, glioma, head & neck, hepatic, melanoma, NSCLC, ovarian, pancreatic, prostate cancer |
| CNS - ADHD, Alzheimer's, epilepsy, migraine, MS, sleep disorders, stroke | Ophthalmology - glaucoma, macular degeneration |
| Dermatology - actinic keratosis, basal cell carcinoma, hyperhidrosis, psoriasis, tinea | Psychiatry - bipolar disease, depression, schizophrenia |
| Endocrinology - diabetes type I and II, HRT, obesity, osteoporosis | Respiratory & Allergy - asthma, bronchitis, cystic fibrosis, emphysema, pneumonia, rhinitis |
| Hematology - CTCL, DVT, leukemia, lymphoma, myeloma, PTCL | Rheumatology - Osteoarthritis and Rheumatoid Arthritis. |