With ClinicReady, our 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.
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.
Our ClinicReady team of scientific and medical affairs specialists comprises PhD qualified individuals with decades of experience in industry and academic research. Our experienced team provide 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.
ClinicReady by Avance Clinical offers the following services:
- 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