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
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.
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.
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.
Observational & Exploratory Studies
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.