Site Information

At Genesis Research Services, 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.

With 15+ years of experience in clinical trials conduct, we offer an extensive range of clinical expertise across a variety of therapeutic areas and phases of clinical trials, including first-in-human device trials and investigator-initiated studies. Genesis Research Services is considered a global leader in the field of pain medicine and neuromodulation.

We provide sponsors and CROs 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.

Therapeutic Areas

  • Pain Medicine
  • Rheumatology
  • Neurology
  • Gastroenterology
  • Hepatology
  • Orthopaedic Surgery
  • Neuromodulation
  • Vaccines

Dedicated Team

Our investigators include pain specialists, rheumatologists, general practitioners, gastroenterologists, and an orthopaedic surgeon. Our coordinators are trained in ECG, venepuncture, fibroscan, dangerous goods handling, physical and mental health first aid, HREC management, CTMS, and electronic site files and source documentation. All staff hold current ICH Good Clinical Practice (GCP) certificates.
About Us

Competitive Timelines

We aim to finalise contract negotiations with 2 weeks and plan for feasibility to recruitment within 8-12 weeks. Our highly motivated staff strive to have agreements and budgets reviewed and returned same day as received, and internal governance review approvals within 2-3 days. Independent ethical review is provided by Bellberry Limited, with 12 HRECs meeting up to 3 times per week. Full ethical review is expected within 6 weeks.

Quality Focused

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.

Population Profile & Access

Newcastle is the 7th largest city in Australia, with a progressive community of 460,000 people, and a total of 730,000 people within the Hunter Valley region.

Our participant registry contains over 12,000 potential trial participants. As a division of Hunter Pain Specialists, we also have access to an extensive population of patients with a range of acute and chronic pain conditions.

Our site is a 30-minute drive from Newcastle Airport and a short walk from Broadmeadow train station. Participants and visitors have access to free parking on site.

Site Features

  • Multiple clinical rooms & offices
  • Pathology room with pharmacy
  • Sponsor delegate monitoring space
  • Building alarms & lockable rooms
  • Secure storage of IP & trial documents
  • Offsite archiving at secure storage facility

Equipment

  • Vital signs equipment
  • ECG machine
  • Spirometer
  • Refrigerated centrifuge
  • Pharmacy drug safe
  • Ambient, 2-8°C, -20°C & -80°C IP storage
  • Digital temperature monitoring & excursion alerts for all IP

Provider Affiliations

  • Local private hospital
  • Nearby day surgery centre
  • Psychologists & psychiatrists
  • Access to ophthalmologists
  • Imaging & pathology providers with research experience

Contact our feasbility team