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

Lower back pain - Newcastle Research Institute - Genesis Research Services
Medical Devices
Neuromodulation Studies

We have worked on numerous neuromodulation device studies, particularly spinal cord stimulation for chronic low back and/or leg pain. Dr Marc Russo has extensive experience in conducting “first-in-human” device implants. 

We take great care of our participants, performing all surgical implants at Lingard Private Hospital and suitable procedures at Hamilton Day Surgery Centre.

Newcastle Research Institute - Genesis Research Services
Chronic Pain
Pharmaceutical Studies

We have specific experience in conducting chronic pain clinical trials, including neuropathic pain. Painful diabetic neuropathy, post-herpetic neuralgia, and complex regional pain syndrome (CRPS) are conditions regularly seen by our pain specialists. As such, we have conducted many clinical trials for these indications.

Newcastle Research Institute - Genesis Research Services
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.

Osteo knee - Newcastle Research Institute - Genesis Research Services
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.

Vaccination - Newcastle Research Institute - Genesis Research Services
Vaccines
Pharmaceutical 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.
Newcastle Research Institute - Genesis Research Services
Investigator-Initiated Studies
Observational & 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 complex pain conditions.

Our Facilities

GCP - Ethics - Newcastle Research Institute - Genesis Research Services
Ethics & Good Clinical Practice

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 Good Clinical Practice (GCP) certificates. Our management team has developed a TransCelerate accredited ICH-GCP online training course.

ICH-GCP Course

Newcastle Research Institute - Genesis Research Services
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.

ISO9001 Newcastle Research Institute - Genesis Research Services
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.

Doctor and patient - Newcastle Research Institute - Genesis Research Services
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 Research Institute - Genesis Research Services
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 within walking distance to our site. Transport around Newcastle is reasonably easy. Participants have access to free parking on site.

Newcastle Research Institute - Genesis Research Services
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.