Clinical Trials at Genesis

We are dedicated to enhancing clinical trials research in compelling ways by combining advances in technology with expert medical care. Through clinical diligence, we strive to help others by providing access to new treatments, supporting our sponsors by delivering data excellence, and contributing to the progression of medical research.

We offer an extensive range of clinical expertise across a variety of therapeutic areas and phases of clinical trials conduct. Genesis Research Services is considered a global leader in the field of pain medicine and neuromodulation.

We provide pharmaceutical, biotechnology and clinical research organisations with a dedicated team of professionals and a purpose-built facility designed to meet the needs and requirements for conducting clinical trials. We also provide specialist proficiency for trial supporting services that are aimed at attaining trial and investigator development.

Clinical Trials Experience

Medical Devices
Medical DevicesNeuromodulation Studies
We have worked on numerous spinal cord stimulation studies. Dr Marc Russo has extensive experience in conducting “first-in-human” device implants. We take great care of our participants, conducting all surgical implants at Lingard Private Hospital and suitable procedures at the Hamilton Day Surgery Centre.

Study List
Chronic Pain
Chronic PainPharmaceutical Studies
The Genesis team has specific experience in neuropathic pain clinical trials. Painful diabetic neuropathy, post-herpetic neuralgia and complex regional pain syndrome are conditions regularly seen by our pain specialists. As such, we have conducted many clinical trials for these indications.
Rheumatology Pharmaceutical Studies
We are regularly involved in conducting trials for ankylosing spondylitis, spondyloarthritis, rheumatoid arthritis and psoriatic arthritis. We conduct these studies with local rheumatologists: Dr David Mathers and Dr John Van Der Kallen.

Musculoskeletal Pharmaceutical Studies
We have recruited a large number of participants into various osteoarthritis of the knee clinical trials. Our enrollment record in this area is impressive! In one study, we randomized 30 participants onto a single trial in just 3 months, closing recruitment in record time.
Study List
VaccinesPharmaceutical Studies
We are set up to ensure the facilitation of high volume studies, such as influenza vaccine clinical trials involving healthy populations. We have consistently enrolled over 100 participants into vaccine clinical trials.
Investigator-Initiated Studies
Investigator-Initiated StudiesObservational & Exploratory Studies
Did you know that we develop and conduct our own studies? Some of these involve collaborations with university researchers. We have successfully initiated studies involving new stimulation programs for chronic back pain, as well as immune profiling studies for neuropathic pain conditions.

Our Facilities

Ethics & ICH-GCP
Ethics & ICH-GCP
We use Bellberry Human Research Ethics Committees (HRECs) for all of our clinical trials.
The time from submission to approval for a new application is approximately 6 weeks.
Our staff are all trained and experienced in HREC management. Our investigators are equipped to provide consultation regarding protocols in relation to ethics approvals.

All Genesis staff and investigators hold current ICH-GCP certificates. Our management team has developed a TransCelerate accredited ICH-GCP online training course.

Investigational Product Storage
Investigational Product Storage
All investigational products (IP) are stored on-site in our dedicated pharmacy. We have a qualified pharmacist on site who oversees our IP pharmacy.

We have equipment on-site for IP storage at ambient temperature, 2-8°C, -20°C and -70°C. All of our storage systems have digital temperature monitoring and excursion alerts. We also have secure storage for investigational medical devices.

All IP storage is lockable and kept in a lockable room. Our facility is equipped with alarm systems and multiple locks.

Quality Management
Quality Management
We are the only private clinical trial site in Australia to have an ISO9001 accredited Quality Management System. All areas of our business adhere to this strict standard.

We conduct regular reviews of our operating procedures and provide relevant standard operating procedures to our clients for their records. Our staff also generate study-specific policies and procedures where appropriate.

Dedicated Research Centre
Dedicated Research Centre
We are an independent research centre consisting of 4 clinical rooms, multiple offices, and a sponsor delegate monitoring space.

Site visitors have access to Wi-Fi, scanning, printing and copying services, and private on-site parking.

Newcastle, NSW - Prime Location
Newcastle, NSW - Prime Location
Newcastle is the 7th largest city in Australia, with a progressive community of 480,000 people, making it a great location to conduct clinical trials.

Newcastle Airport is within 30 minutes drive and Broadmeadow train station is in walking distance to our site. Transport around Newcastle is reasonably easy. Participants have access to free parking on site.

Provider Affiliations
Provider Affiliations
We have affiliations with local private hospitals, a nearby day surgery centre, and imaging and pathology providers.

All of our providers have research experience and are able to support our projects with varied resources to ensure our clients’ needs are met.