Statistical and Pharmacokinetics Services

End-to-end data management

Avance Clinical’s Statistical and Pharmacokinetics Services provide in-house end-to-end data services using streamlined capture, analysis and reporting pathways.

Regulatory-compliant

Our team provides a range of services related to the regulatory-compliant CDISC model, with a focus on the SDTM and ADaM standards and their supporting documentation.

We ensure full data traceability and track value level metadata so that our supporting Define.xml complies to Pinnacle21 validation and our deliverables are submission-ready for your clinical research trial.

Statistical and Pharmacokinetics Services

Our Statistical and Pharmacokinetics Services include:

Optimized study design and protocol review, including sample size calculations
Statistical Analysis Plan (SAP) development
Comprehensive suite of randomization solutions
CDASH conforming CRF design
CDISC compliant SDTM and ADaM dataset implementation
Conversion of legacy data for current submissions
Complex statistical analysis
Rapid PK analysis for interim decision making
Tailored presentation of individual data and aggregated data
Use of validated specialist software (WinNonlin and SAS)
Clear and concise communication to all stakeholders
Embedded quality assurance
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

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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
Study participants (past 5 years)
24
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

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