Safety and Pharmacovigilance

Complete range of in-house services

Clinical trials safety monitoring and reporting is vital to ensure participant safety, data integrity and regulatory compliance.

Regulatory guidelines around clinical trial safety monitoring and reporting demand strict safety management procedures, from a highly-skilled, and experienced safety team.

Technology

Avance Clinical’s state-of-the-art built-for-purpose technology facilitates the management, reporting, and analysis of key safety information that may arise during study conduct.

Our safety monitoring and reporting services ensure regulatory compliance, and monitoring of the study drug safety profile to identify, evaluate and minimise safety-related risks at a reasonable cost.

Deep Regulatory Knowledge

As the leading Australian CRO for biotechs, Avance Clinical’s clients benefit from deep regulatory knowledge of the Australian and New Zealand clinical environment, a state-of-the-art safety and pharmacovigilance electronic database Argus, and a multi-disciplinary safety team with diverse therapeutic area expertise and decades of experience in safety management and reporting.

In-house Safety and Pharmacovigilance Services

Study-specific training for Investigational Sites on Safety Reporting
Argus Sponsor enterprise set-up and Study-Specific Safety Database set up
Preparation of the Study Specific Safety Reporting Plan, Safety Reporting Forms and relevant guidelines for the Investigational Sites

Receipt and processing of Individual Case Safety Reports in Argus

Data entry, Medical Coding (MedDRA and WHODD), QC, Medical Review and Distribution
Follow-up and query management
Expedited reporting of SUSARs and other safety information such as Significant Safety Issues and Urgent Safety Measures to relevant stakeholders such as Regulatory Authorities, ECs and Investigators
Periodic Safety reporting to local ECs and Investigators
DSUR distribution and submission to Investigations and ECs
Preparation and submission of Annual Safety Reports in Australia
The Australian Government R&D grant means up to 43.5% rebate on clinical trial spend
No IND required for clinical trials
Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks
Globally accepted data
Clinical Trials

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More benefits

Avance Clinical can leverage all the benefits of Australia and New Zealand’s clinical ecosystem to deliver your study

Almost half clinical costs

The Government R&D grant means up to 43.5% rebate on clinical trial spend

Rapid Start-up

Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks

Start-up time

Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks

No IND

No IND required for clinical trials

GMP material

Full GMP material is not mandated for Phase I clinical trials

Gene-therapy accreditation

Avance Clinical is an accredited gene-therapy CRO

Seasonal studies

Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia and New Zealand's counter-flu and allergy seasons

FDA and global regulatory data compliance

Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track record in FDA compliant research

Rebate

The Government R&D grant means up to 43.5% rebate on clinical trial spend

Start-up time

Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks

Capabilities

Full service CRO in Australia and New Zealand

195
Studies in the past 5 years
150
Experienced Team Members
10,000
Participants in the past 5 years
24
Years of of CRO experience

“Within Asia-Pacific’s highly competitive CRO market, Avance Clinical stands out as a leader in early phase biotech clinical trials.

The company offers a highly responsive and proactive service for biotechs wanting rapid and innovative clinical trial solutions, with the highest level of data compliance. Avance Clinical offers a real size match for biotechs that means better mission understandings and stronger customer service compared to some of the larger CROs.”

Nidhi JalaliAnalyst Best Practices, Frost & Sullivan

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