Site Capabilities

Clinical Research Excellence in Newcastle

Genesis Research Services brings 15+ years of experience to phase I–IV clinical trials across a range of therapeutic areas. We are a recognized world leader in pain medicine and neuromodulation research.

Our diverse team, purpose-built facility, competitive timelines, and internationally accredited QMS ensure study conduct meets the highest benchmarks for safety, efficiency, and regulatory compliance.

Therapeutic Experience

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

Diverse Team

Our investigators include pain specialists, rheumatologists, general practitioners, gastroenterologists, and more.
Our study 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.
Our team includes a qualified pharmacist, medical writer, and digital recruitment specialist.
All staff maintain ICH GCP certification.
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 approvals within 2-3 days. Independent ethical review is provided by Bellberry Limited, with HRECs meeting up to 3 times per week. Full ethical review is expected within 6 weeks.

Quality Focused

We are proudly GCSA certified by The International Accrediting Organization for Clinical Research (IAOCR). This site-specific accreditation recognises our commitment to the highest international standards of quality, ethics, and performance in clinical research. We are also fully recognised by NSW Health under the Quality Recognition Scheme (QRS). Our robust Quality Management System supports consistent and compliant trial conduct. Study-specific procedures are developed as needed.

Population Profile & Access

Newcastle is the 7th largest city in Australia, with a progressive community of over 500,000 people, and a broader catchment of approximately 800,000 people within the Hunter Valley region.

Our participant registry contains over 12,000 potential trial participants. We are affiliated with Hunter Pain Specialists, providing 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. Free private parking is available to our participants and visitors and is located to the right of our building.

Site Features

  • Dedicated clinical rooms & office spaces
  • Pathology room & laboratory
  • On-site pharmacy with drug safe
  • Sponsor delegate monitoring workspace
  • Building alarms & lockable stores
  • Secure storage of IP & trial documents
  • Off-site archiving at secure storage facility

Equipment

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

Provider Affiliations

  • Local private hospitals
  • Partnering pain and gastroenterology clinics
  • On-site infusion clinic
  • Imaging & pathology providers with research experience
  • Access to psychologists, psychiatrists, physiotherapists, & ophthalmologists

Contact our feasibility team