Skip to main content

safety reporting services

Safety Reporting Services

Safety monitoring and reporting

Safety monitoring and reporting in clinical research trials ensure both patient safety, data integrity, and regulatory compliance.

Strict regulatory guidelines on clinical trial safety monitoring and reporting necessitate the preparation and implementation of study-specific safety monitoring and reporting strategies and procedures.

Our safety monitoring and reporting services help you ensure regulatory compliance, with optimal efficiency at a reasonable cost.

Regional regulatory knowledge

As a leading Australian CRO, our clients benefit from our regional regulatory knowledge, quality systems approach multi-disciplinary safety expertise, and adherence to reporting timelines of the Australian Therapeutic Goods Administration (TGA) and other competent authorities.

Complete study-specific safety reporting services

Our Statistical and Pharmacokinetics Services include:

Avance Clinical offers complete study-specific safety reporting services, which include data collection, processing, review, safety report writing, and reporting. Our dedicated safety monitoring and reporting team comprise highly skilled individuals with in-depth knowledge in diverse therapeutic areas and several years of clinical trial safety management services experience.

Safety Management
Reporting Plans/ Forms
SAE Narratives
Reporting to Local Regulatory Authorities and Ethics Committees
Expedited/Periodic Safety Report Distribution
Training of trial investigators and site study staff on study-specific monitoring and reporting
Dedicated service with 24/7 phone and fax lines to receive information on adverse events from clinical trial sites
Collection, evaluation, analysis and reporting of safety information
Coding of Adverse Events (MedDRA)
Review of case reports
Preparation and submission of Safety Update Reports to the TGA and other relevant authorities
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
How we work

Learn more about how we work

Request a Proposal or Talk to our Team  CONTACT US

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 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


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


Full service CRO in Australia and New Zealand

Studies in the past 5 years
Experienced Team Members
Study participants (past 5 years)
Years of of CRO experience

“Avance Clinical’s clients are international biotech companies primarily from the United States, United Kingdom, Japan, China, South Korea, Taiwan, France, and Germany. These clients are seeking a premium CRO with the same experience and advanced technology platforms offered by the major global CROs, but with an agile and customer focused approach to clinical management in Australia and New Zealand.”

Supriya Lala KunduBest Practices Research Analyst, Frost & Sullivan

Ready To Partner with Us?

Contact Us