ClinicReady
The Preclinical CRO Team for Biotechs
Have an emerging preclinical asset and unsure of all the steps to reach the clinic? ClinicReady is your outsourced team of Ph.D.-qualified scientific and regulatory affairs specialists with you from preclinical planning through Phase I and beyond.
Full Preclinical CRO Support
Before committing budget to preclinical safety and toxicology work, you need to know you’re running the right studies. The ClinicReady team can engage before preclinical activities begin to ensure every study generates data that supports the transition to clinical and sets your asset on a GlobalReady development path.
Scientific & Regulatory Affairs
Embed in-house scientific and regulatory affairs specialists in your program from the start.
Gap Analysis
Data review to identify what you have and what your IND package still requires
Regulatory Submission Support
Study design built for approval from the earliest stages
Trial Design
Proof of Concept (POC) endpoints and key data collection strategy aligned to regulatory expectations
Protocol Review
Experienced scientific and medical team oversight
Later-Phase Strategy Integration
A development roadmap that takes you from preclinical to Phase I and beyond
Preclinical Vendor Selection & Management
Trusted partners, already vetted by the Avance Clinical network
Clinical Trial Design & Medical writing
Access a comprehensive suite of scientific, regulatory, and medical writing services — from study protocols to investigator’s brochures.
Therapeutic Area Advice
30+ years of cross-indication experience across oncology, CNS, renal & metabolic, and more
Chemistry, Manufacturing & Controls (CMC) Advice
Specialist input at every stage of development
Investigator's Brochure Preparation
Expert communication of study design and process
Study Protocols and Clinical Trial Designs
Rigorous, regulator-ready protocols built to streamline approval and execution
Patient Information & Consent Form Development
Clear, compliant documentation that supports informed consent across your study population
Clinical Study Reports
Comprehensive, audit-ready reporting of trial data structured for regulatory submission
30+ Years of Deep Clinical Research Management
250+ Indications
Deep therapeutic experience across oncology, CNS, renal, metabolic, rare disease, and more — spanning every stage of clinical development.
Extending Budgets by up to 43.5%
Secure the Australian Government R&D rebate on your clinical trial spend when you advance to Phase I.
Extending Budgets by up to 43.5%
Secure the Australian Government R&D rebate on your clinical trial spend when you advance to Phase I.
Globally Accepted Data
From your first preclinical protocol, every data point is structured to meet FDA, EMA, TGA, and all major regulatory authority standards.
ClinicReady in Action
Tetherex Pharmaceuticals
"The Avance team demonstrated flexibility and a solution-oriented attitude in working with us towards obtaining rapid ethics approval, thereby facilitating trial initiation in a timely and efficient manner." - Dr. Russell Rother, President and Chief Operating Officer
Frequently Asked Questions
Get answers to frequently asked questions about Avance Clinical’s ClinicReady preclinical CRO services.
ClinicReady is Avance Clinical’s outsourced preclinical CRO service. It provides early-stage biotechs with a surrogate drug development team — Ph.D.-qualified scientific and regulatory affairs specialists who guide preclinical planning, regulatory submissions, and clinical trial design.
A preclinical CRO supports biotechs before their first human clinical trial. Services typically include gap analysis of existing data, design and oversight of studies and trials, preparation of drug development plans, regulatory submission support, vendor selection and management, and early clinical trial design. Avance Clinical’s ClinicReady covers all of these through an integrated outsourced team model.
Yes. ClinicReady’s scientific and regulatory affairs team works with early-stage biotechs to ensure that the preclinical studies they conduct generate the data required to support an IND application and first-in-human approval. This includes study design, protocol review, and regulatory agency submission support.
ClinicReady is designed for early-stage biotech companies and startups advancing a preclinical asset that want to benefit from an outsourced drug development model. It’s particularly well-suited to lean teams without in-house scientific or regulatory affairs expertise.
Most preclinical CROs execute individual studies. ClinicReady acts as your surrogate drug development team, providing strategic oversight across the entire preclinical program. That includes gap analysis, regulatory planning, vendor management, and clinical trial design. It connects your preclinical work to your Phase I strategy from the start.
ClinicReady is the first stage of Avance Clinical’s GlobalReady model. Once your preclinical foundation is in place, the same Avance team transitions with you into early-phase clinical trials, preserving institutional knowledge, data continuity, and your development roadmap. There is no handoff to a new CRO.
Avance Clinical has therapeutic experience across more than 250 indications and operates Centers of Excellence in Oncology, CNS, Early Phase, and Renal & Metabolic. ClinicReady’s team provides therapeutic area advice as part of the service.
Avance Clinical is headquartered in Australia and has direct operations across Australia, New Zealand, and North America, with established operations in South Korea and Taiwan — expanding into Singapore, Malaysia, India, and mainland China. European programs are delivered through the GlobalReady framework.
For early-phase trials, Australia offers significant advantages, including no IND requirement, fast site initiation, and up to 43.5% of eligible trial spend returned through the R&D Tax Incentive. Learn more about the Australian Advantage
Pressure-Test Your Preclinical Program Before Stakes Rise
ClinicReady gives you the expertise to get critical preclinical decisions right.