GRS Newsletter – September 2019

Staff Updates

Farewell, Tiana
Farewell, Tiana
In July 2019, our longest-serving team member, Tiana, left Genesis Research Services to begin a new career as an early childhood educator. Tiana joined the then Hunter Clinical Research team in 2013 as a business administration trainee.

For the past 2 years, Tiana has been studying for her qualifications in early childhood education and graduated in June 2019. Not surprisingly, Tiana made such a great impact on her short placement, that she was offered a full-time role.

Tiana was a valued team member and a pleasure to work with throughout the years. She kept our staff, investigators and participants organised, and greeted all with a friendly smile. We wish Tiana all the best with her new career!

Welcome, Dr Jane Morgan
Welcome, Dr Jane Morgan
A warm welcome to our newest investigator, Dr Jane Morgan!

Dr Morgan is an experienced General Practitioner with a special interest in women’s health. She has worked in numerous rural areas around NSW and is currently practicing in Hamilton, Newcastle. Dr Morgan is a passionate advocate for human rights and has a deep appreciation for the natural environment.

Dr Morgan’s research interests lie in primary care projects that will have a real community benefit, with a specific focus on conditions that are beyond human control, inherited or otherwise. Dr Morgan’s addition has expanded our capacity to participate in high volume primary care and vaccine studies.

Welcome, Ashlie
Welcome, Ashlie
Earlier this year, we welcomed new clinical trial coordinator – Ashlie – to our team.

Ashlie is a registered nurse, and is working with us in a part time capacity to assist with our general medicine and back pain clinical trials. She is passionate about patient focussed care in order to provide positive health outcomes for her study participants.

Welcome, Amy
Welcome, Amy
Amy is the most recent addition to the Genesis team. She has taken on the role of research services administration coordinator.

Amy has a diploma in business administration, retail management experience and a bubbly personality. She has a strong desire to challenge herself and grow her extensive administration skill set.

New Business

Website Updates

We’ve made a few updates to the Genesis website:

  • Head on over to our ABOUT page to learn more about our investigators and research team.
  • Our new CLINICAL TRIALS page showcases our clinical trials experience and dedicated facilities.
  • To make it easier for prospective participants to find and apply for currently enrolling clinical trials, we created the JOIN A TRIAL page.
  • We have also opened up an EDUCATION portal through which investigators and research personal can access GRS-developed online training courses. Currently, we have one course on offer: an accredited Good Clinical Practice (ICH-GCP) course. A comprehensive site development course is in the works.
  • A link to our Privacy Policy now appears in the footer of every page of the website.

Next on the list is a new homepage!

GCP Online Training

Did you know that you can complete your Good Clinical Practice (GCP) training online with us? We developed and launched our very own Good Clinical Practice (ICH-GCP) course earlier this year. The course is designed to prepare investigators and research staff for the conduct of clinical trials.

The training program consists of 12 modules, providing an overview of GCP, the principles of ICH-GCP, the Australian regulatory environment, and investigator responsibilities. The course content, final quiz and certificate are compliant with the TransCelerate Site Qualification and Training (SQT) Initiative’s Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6 R2), which enables the mutual, professional recognition of GCP training within the Australian clinical research industry.

Click here to read more about the course and view the complete list of modules.

BeforeAfter
Pathology Room Makeover
Earlier in the year, we started the first phase of our pathology facility upgrades, which was to replace the flooring and purchase a pathology chair. This allowed us to participate in a large healthy-volunteer study investigating a potential booster to the flu vaccine.

Phase 2 of the upgrade has just been completed. This involved installing custom benchtops and cabinetry. We think the new room looks fantastic!

Site Statistics
Site Statistics
In the 2018 – 2019 year, we had over 860 participant visits on site as part of our clinical trials. Well done, team!

Events

SCRS
SCRS
Members of our clinical and business teams attended the Society of Clinical Research Sites – Site Solutions Summit in Melbourne this year. It was the first time Katie and Heather attended the summit. Everyone enjoyed the conference experience.

Dom and Mel were involved in panel discussions throughout the summit and contributed knowledge from their clinical research experience. Here they are with the President of SCRS.

Clinical Research - Business Essentials Education Workshops
Clinical Research - Business Essentials Education Workshops
This year, our Business Development Manager, Mel, was commissioned by Praxis Australia, a clinical research education provider, to develop and host multiple workshops around Australia to improve the essential business knowledge required by clinical staff to manage a clinical trials centre.

So far this year, more than half of the workshops have been sold out and all of the workshops have received rave reviews for their relevance and excellent delivery.

First Investigator-Led Network Project
First Investigator-Led Network Project
We have designed and received grant-funding for a new clinical trial using an intrathecal drug pump for people who have not had success with spinal cord stimulation therapy. We are managing this study across multiple investigative sites, with many of Australia’s great pain specialists.

In early 2019, we hosted the Investigator’s Meeting, which marked the first major milestone for the project. The management and investigative teams attended, along with representatives from the device manufacturing company.

Study Highlights

Influenza Vaccine Study
Influenza Vaccine Study
We greatly exceeded our target of 200 participants when we successfully enrolled 288 participants for this study! We successfully included the requested percentage of participants over the age of 65 years. This is very important as the client needs to assess the impact of the investigational injection on participants in the older population.

Well done to the lead clinical trial coordinator, Michael, the entire GRS team, and all of our investigators who contributed their time and expertise to this study! Everyone committed to the success of this project and it was great to see the team at their best!

First Patient in Spine Injection Study in Australia
First Patient in Spine Injection Study in Australia
Dr Russo was the first investigator to enrol a participant in a study involving a new investigational injectable therapy for degenerative disc disease. This study aims to reduce low back pain by improving the structural integrity of the spine and restoring the strength of spinal discs.

This is a fantastic achievement for the lead clinical trial coordinator, Heather, our doctors, and the day surgery and imaging teams who made this possible.

New Journal Publication

CRPS Immune Profiling

Last year, Dr Russo and the Genesis team entered into a collaborative research project with Dr Paul Austin and his research team at the University of Sydney. In this study, we collected blood samples from volunteering patients with complex regional pain syndrome (CRPS) and healthy participants. Dr Austin’s team performed immunophenotyping to investigate differences in immune cells between patients and controls. We found increased numbers and activation of several white blood cell subsets. The research was published in March this year. Congratulations to both teams and a huge thank you to all of the volunteers who participated in the study.

You can view the publication for free here.

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