Into Clinic Faster

Surrogate drug development department for start-up companies

Avance Clinical has a dedicated scientific and regulatory affairs service, ClinicReady, headed up by Gabriel Kremmidiotis, Chief Scientific Officer, Avance Clinical (pictured on right with Jorgen Mould PhD, BSc (Hons) Avance Clinical’s Scientific Affairs Specialist – left).

Biotech Demand

This is in response to increased demand from biotechs for preclinical study management and scientific and regulatory advice to take their products to first-in-human trials.

Start-up Challenges

The ClinicReady range of services constitutes a natural progression in Avance Clinical’s role as the premier provider of early drug development support to the biotechnology sector. The company recognises the major challenges faced by small biotechnology companies, particularly start-up companies who seek to drive their novel therapeutics to demonstration of safety and preliminary clinical Proof of Concept.

Drug Development Department

With ClinicReady, Avance Clinical’s team can act as a surrogate drug development department for start-up companies who are looking to benefit from a virtual model of operationalisation and execution from the early stages of drug candidate discovery to demonstration of preliminary clinical POC.

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See our latest client case study
Read about our Intranasal Expertise in Fierce Biotech
Learn about ClinicReady in Endpoints News

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Learn about First Pass Approval Rates

ClinicReady First Pass Approval Record

What is ClinicReady?

ClinicReady is your outsourced drug development department.

ClinicReady is designed for start-up companies who are looking to benefit from a virtual model of operationalisation and execution from the early stages of drug candidate discovery to demonstration of preliminary clinical POC.

The right data

Our team of scientific and medical affairs specialists advise clients early in the development process, prior to them commencing preclinical safety and toxicology activities, so they conduct an appropriately balanced set of preclinical studies to get the right data for approval of their first-in-human study in Australia.

Scientific and medical affairs specialists

The ClinicReady team of scientific and medical affairs specialists comprises PhD-qualified individuals with decades of experience in industry and academic research.

Clinical trial designs

The experienced team provides clients with scientific, regulatory, and medical writing services, preparation of investigator’s brochures, clinical trial designs, and study protocols, and patient information and consent forms as well as clinical trial data and clinical study reports.

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Gap Analysis
Preparation of Drug Development Plans
Pre-clinical vendor selection and management
Scientific Advice
Therapeutic Area Advice
Chemistry Manufacturing Controls (CMC) Advice
Preparation of Investigator’s Brochure
Regulatory agency submission support
Medical writing services
The Australian Government R&D grant means up to 43.5% rebate on clinical trial spend
Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks
No IND required for clinical trials
Globally accepted data
Scientific and Medical Affairs

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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
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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

Ready to Get Your Drug into Clinic?

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