NOVOTECH (australia) Pty Ltd
Level 3, 235 Pyrmont Street
Pyrmont, NSW 2009, AUS
Contact Person: Julia Jones, Executive Director, Business Development
Clinical Trial Monitoring, Data Management, Electronic Data Capture, Medical Writing, Project Management, Protocol Development, Quality Assurance/Control, Regulatory Affairs/Regulatory Strategy, Statistical Services/Meta Analysis, Trial Management
Novotech is internationally recognized as the leading Asia Pacific focused clinical CRO headquartered in Australia with operations throughout the region. With a track record of 18 years and hundreds of clinical trials from First In Man to post approval services, Novotech’s full service offering includes:
Biometrics Services (Clintrial®, Medidata®, Viedoc®, SAS, WinNonlin®)
Pharmacovigilance (Empirica Trace®)
Quality Assurance Audits
Regulatory Affairs Consulting
Third Party Vendor Management, including Contracts Management
All projects are supported by state-of-the-art technology, including real time access to daily project progress powered by Oracle Siebel, the industry leading CTMS platform.
Novotech’s clients are predominantly US and European based pharma and biotech companies engaged in Phase II/III registration studies for FDA and EMEA submissions. The following markets are covered:
Australia, Hong Kong, India, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand
Novotech is committed to further expansion in the region, and routinely partners CROs from other regions for seamless service delivery on global projects, for which it is regularly audited to FDA requirements.
Adverse Event Management/Software, Case Report Forms, Clinical Study Reports, Clinical Trial Monitoring, Data Management, GCP Compliance, Pharmacovigilance, Project Management, Statistical Services/Meta Analysis, Trial Management