Service Features
The Research Directorate aims to make St Vincent’s a premier and preferred site to conduct sponsored clinical trials across a broad range of disciplines.
To improve support for sponsors, researchers and companies, the Research Directorate is proud to announce the Research Valet Service.
Valet includes full HREC submission preparation and liaison throughout the submission and approval process. St Vincent’s Hospital Melbourne is not required to be a participating site to utilise this service.
* Additional fees apply for more complex submissions e.g more than 8 PICFs or more than 50 documents. Please contact us for more information.
Download brochure| Valet® Fee (AUD) | $5,500 + GST* |
|---|---|
| Service Provision | Full |
| Complete preparation & review of all ethics documentation: - PICF Master - HREA & distribution of site SSAs - Victorian Specific Module |
|
| Single point of contact for ethics and HREC liaison | |
| Coordination of essential documentation | |
| Distribution of approved documents to CRO Sponsor/Sites as required | |
| Submission acknowledgement from HREC Secretary | |
| Committee review acknowledgement/decision within two business days of meeting | |
| Ethics outcome within 30 days+ (Excludes First in Human and Phase 1 trials) |
+ dependent on fast response timelines from sponsors to valet comments/recommendations
Research Valet®
Lead Site Management
St Vincent's Hospital Melbourne Research Directorate also offers Research Valet post approval management services that facilitates all post approval project submissions and ongoing ethics management.
This service provides researchers a smooth start up with a highly competitive timeline to gain ethics approval, providing St Vincent’s a competitive edge on the global market for clinical trials.
| Post Approval Management* | Cost |
|---|---|
| Major amendment fee (IB, Protocol submission with additions to ICF, Addition of sites exceeding 4 sites, Total number of documents exceeding 20) | $1,000 |
| Intermediate amendment fee (IB, Protocol submission without updates to ICF, Addition of sites (2-4) only, Administrative and patient facing documents exceeding 20) | $750 |
| Minor amendment fee $500 (Administrative and patient facing documents, Addn of single site) | $500 |
| Submission of documents for HREC email acknowledgement | $100 |
*Amendments will receive acknowledgement of receipt on the day (within standard operating hours) and be submitted once review is finalised in consultation with the study sponsor.
Research Valet®
St Vincent’s
The key feature of this unique service is close communication between sponsors/researchers and the Research Valet team at each step of the process.
Sponsors or researchers will receive study outcome within 30 days of HREC meeting (except First in Human/Phase 1 studies), and governance approvals will be targeted at seven days after submission of all required documentation.
Senior members of the Research Valet® Team include:
Dr Megan Robertson, Director of Research
As a current clinician (ICU) and over 10 years as Research Director in both the public and private sector, Megan has focused on facilitating research and embedding clinical research as a core component of clinical care. Her clinical knowledge and experience running clinical trials at the bedside provides a deep understanding of the trial process and the requirements for effective and efficient governance.
Dr Trixie Shinkel, Research Valet Manager
Trixie joined the Valet team in 2018, bringing over 20 years of HREC and research governance experience to her position. Trixie is the first point of contact for all Valet enquiries and manages our strict timelines and close communication processes. Trixie has a BSc (Hons) and PhD in neuroendocrinology and broad experience in preclinical and clinical research.
