Contact Information
NOVOTECH (australia) Pty Ltd
Level 3, 235 Pyrmont Street
Pyrmont Sydney, NSW 2009, AUS
Phone: 285691400
Fax: 285691496
Internet: www.novotech-cro.com
Email: julia.jones@novotech-cro.com
Contact Person: Julia Jones, Executive Director, Business Development
Services
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
Description
Novotech is the leading Asia Pacific focused clinical CRO headquartered in Australia with operations throughout the region
Novotech is internationally recognized as the leading Australia based clinical CRO. With a track record of 15 years and hundreds of clinical trials from First-In-Man to post approval services, Novotech’s full service offering includes:
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Feasibility Assessment
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Project Management
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Monitoring
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Biometrics Services (Clintrial®, Medidata®, SAS, WinNonlin®)
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Pharmacovigilance (Empirica Trace®)
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Quality Assurance Audits
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Regulatory Affairs Consulting
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Third Party Vendor Management, including Contracts Management
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Local Sponsorship
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.
Markets Covered
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, India, Malaysia, New Zealand, 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.
Services
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
http://www.novotech-cro.com/