About the NSW Clinical Trials Business Development Centre

If you want to know more about conducting clinical trials in Sydney or the Asia/Pacific region, the NSW Clinical Trials Business Development Centre is the first point of contact.

We are a one-stop-shop for commercial and non-commercial sponsors wishing to find out more about what Sydney can offer for clinical development.

We have access to outstanding infrastructure for conducting clinical trials and provide clinical trial strategies tailored for product research and development for pharmaceutical, biotechnology and medical device companies.

The NSW Clinical Trials Business Development Centre can connect you with the following services:

Study Design and Management Protocol design and review Investigator brochure write-up Study planning and Implementation Clinical trial management Clinical research form (CRF) preparation Clinical trial (IRB/HERC) approval Site selection and management Pre-clinical trial services Phase I, II, III and IV clinical studies Study monitoring and data collection Multilingual staff and documentation Adverse event reports Medical report writing

Data Management and Analysis Case report form review Data entry/quality control Automatic edit checking and query tracking Statistical services and analysis planning Integrated report preparation Integrated summaries of safety and effectiveness Preparation of SAS data for FDA/EMEA/TGA

Regulatory Affairs Services Regulatory strategy Preparation of IND, IDE, MAA, NDA, PMA, 510k Representation with regulatory authorities, including FDA and TGA Preparation for regulatory meetings Regulatory submission guidance Regulatory affairs submission compliance service

For more information, email info@clinicaltrials.org.au or call  +61 2 8374 3569