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NOVOTECH (australia) Pty Ltd

Description: 

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:

  • Feasibility Assessment
  • Project Management
  • Monitoring
  • Biometrics Services (Clintrial®, Medidata®, Viedoc®, SAS, WinNonlin®)
  • Pharmacovigilance (Empirica Trace®)
  • Quality Assurance Audits
  • Regulatory Affairs Consulting
  • Third Party Vendor Management, including Contracts Management
  • 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, 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.

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/

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

Contact Information: 

NOVOTECH (australia) Pty Ltd
Level 3, 235 Pyrmont Street
Pyrmont, 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