As your trusted clinical partner, we help you achieve your objectives by combining high quality infrastructure, trial participant engagement and care with seamless management across each phase of your trial.
By working together, we help create new healthcare opportunities, connecting people to potentially life-changing treatments, as well as rewarding professional challenges amid the early stage development of medical advancements.
Across our client base of medical and health professionals, pharmaceutical and biotech companies, contract research organisations (CROs) and our patient cohort, we offer unrivalled expertise in clinical trial research management and project management services,
Pharmaceutical,
Biotech and CRO clients
We promise swift, reliable and efficient service, where your clinical study is activated quickly, rigorously and precisely and meets compliance measures.
Comprehensive management from Phases I, II, III to IV
Segmented management for Phases II to IV
Identification and procurement of principal investigators/sites for clinical trial participation
Assembling and aligning multi-disciplinary health professionals to form a clinical trials site team (e.g. engaging an ophthalmologist, physician, pathology technician, medical photographer, masked and unmasked study coordinators and investigators)
Human Research Ethics Committee (HREC) submissions and reporting
Expeditious clinical trial research agreement, budget development and contract execution on behalf of sites
Trial participant identification, recruitment, pre-screening and filtering
Audit preparation for sites and recommendations provision on CAPAs
Serious adverse event reporting
Source documentation template development
Data entry
Management, accountability and documentation of investigational product
Doctors and Health Professionals
We ensure the entirety of your clinical study is managed with ease and expertise you can rely on. For Investigator Initiated Trials (IIT), we work with you from trial inception to prepare and develop all required documentation for your protocol and sample size calculations, through to funding submissions. Our extensive experience in the process of managing sponsored trials means that you can leave the entire process to us.
Comprehensive site management from Phases I, II, III to IV for sponsored or Investigator Initiated Studies
Segmented site management for Phases II to IV for sponsored or Investigator Initiated Studies
Human Research Ethics Committee (HREC) submissions and reporting
Clinical trial research agreement budget development and negotiation
Site feasibility assessments and site selection visit preparation and coordination
Study documentation maintenance
Sponsor relationship management
Staff research training and certification
Representation of site at investigator/coordinator meetings
Site management and accountability of investigational product
Trial participant identification, referral, recruitment and appointment scheduling
Source documentation template development
Data entry
Budget development, negotiation and contract review
Study financial management and reconciliation
Quality assurance processes implementation and SOPs to ensure integrity of study data
Quality control monitoring and auditing of study processes and data
For Investigator Initiated Trials:
Protocol development to ensure validity of data and streamlined trial management
Database searching and development
Article sourcing
Sample size calculations
Funding submissions
Statistical data analysis
Manuscript preparation and submission
“Since the inception of ZAVE in 2014, we have collaborated on a number of trials including some quite complex interventional trials in ophthalmology, which we have successfully managed. In particular we managed to restart a clinical trial for an international pharma who was unable to get any patient recruitment in spite of a year of investment. We were able to recruit patients within the first 3 months. I have been greatly comforted and the burden of running trials greatly eased by the capacity and diligence of the ZAVE team. They have very good attention to detail and understand the difficulties of fitting in travel, surgical dates and other things that intrude upon everyday clinical practice. Flexibility of patient and investigator scheduling (within visit windows) is of paramount importance to successful prosecution of trials. In ophthalmology trials, ZAVE are the premier clinical trials management group.”
Principal Investigator A/Prof Michael Coote, FRANZCO
