Recruitment Process
The recruitment process at Cognivus is managed by our dedicated in-house research team in close collaboration with our multidisciplinary clinical staff. This integrated approach ensures timely, effective, and full participant enrolment across all clinical trials. From study start-up to close-out, our team provides consistent support and oversight to maintain high standards and meet study timelines.
Our team has extensive expertise in Good Clinical Practice (GCP) and adheres to both global and local regulatory standards. We operate under well-established internal Standard Operating Procedures (SOPs), ensuring all research activities are conducted with precision, accountability, and ethical integrity.
We are highly experienced in navigating complex governance and regulatory frameworks, including both local and international requirements. This includes a solid understanding of site-specific governance policies, sponsor protocols, and global compliance expectations.
Our capability in obtaining ethics approvals—whether through Human Research Ethics Committees (HREC) or other relevant regulatory bodies—is well established. We are known for our streamlined ethics submission process and our ability to secure approvals in a timely and efficient manner, supporting rapid study start-up.
Cognivus maintains a robust and diverse participant database and leverages an expansive referral network, including general practitioners, specialists, and allied health professionals. We also employ innovative recruitment strategies—digital outreach, community engagement, and pre-screening tools—to reach and retain eligible participants quickly and effectively.
Cognivus Therapeutic Areas
This section highlights how users can earn rewards through referrals, making engagement beneficial and rewarding for both referrers and new users.
CNS & Pain Disorders
- Neuroscience
- Mental health
- Neuropathic Pain
- Musculoskeletal Pain
- Spinal cord diseases
- Rehabilitation
- Neurology
Internal Medicine
- Cardiology
- Endocrinology
- Respiratory & Sleep
- Urology
- Rheumatology
- Geriatric
- Gynaecology
Immunology & Infectious
- Infectious disease
- Immunology
- Vaccines
- Dermatology
- Medical device
Our Key Partners
Our key partners help us deliver the very best in research and help with the fight against deadly diseases that we are researching.
Case Studies
ASCEND Study
Background: A randomised, double-blind, sham-controlled, multi-centre Phase I/II clinical trial by Vivex Biologics, Inc., to evaluate the safety and effectiveness of VIA Disc NP, a minimally processed human nucleus pulposus tissue allograft, for supplementing degenerated intervertebral discs in participants with symptomatic degenerative disc disease.
Requirements: Enrolment of 110 adult participants across up to 10 investigational sites in Australia. The sponsor aimed to ensure rapid patient recruitment and high-quality follow-up visits.
Outcomes:
- Cognivus recruited 40 patients in under six months.
- Site staff demonstrated flexibility and adaptability when sponsor recruitment targets changed.
- 100% compliance with the study requirement of 24-hour data entry.
- High-quality follow-ups, flexibility, and efficiency contributed to robust data collection.
OMNIA Real-World Audit
Background: A prospective, long-term real-world practice audit evaluating the clinical performance of the Nevro OMNIA 10 kHz spinal cord stimulation system in patients with chronic pain.
Requirements: Recruitment of up to 20 patients over 12 months; all underwent a trial phase requiring ≥50% pain reduction before permanent implantation. Outcomes focused on responder rate, satisfaction, pain relief, sleep, function, and medication use.
Outcomes:
- Cognivus achieved timely patient identification and implantation, with strong retention through 12 months.
- High-quality follow-ups and accurate data reinforced sponsor confidence in site performance.
- Exemplary compliance with GCP and routine practice standards ensured smooth audits and data integrity.
GEMINI Study
Background: A pre-market, prospective, open-label clinical investigation evaluating the safety, usability, and performance of Abbott’s Gemini rechargeable spinal cord stimulation system in patients with chronic intractable pain.
Requirements: Up to 25 participants across 8 Australian sites, with a target of 20 evaluable implants. Participants completed baseline, implantation, and structured follow-ups (2 weeks, 6 weeks, and beyond). Key measures included adverse events, pain relief, patient satisfaction, charging experience, and quality of life.
Outcomes:
- Cognivus ensured smooth participant progression from enrolment to implantation, maintaining protocol compliance at every stage.
- Regular, complete follow-ups enabled accurate data capture and reinforced sponsor satisfaction.
- Effective collaboration with Abbott strengthened sponsor confidence in site quality, flexibility, and regulatory compliance.
Closed-Loop Spinal Cord Stimulation Study
Background: Sponsored by Medtronic, this study, Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop Spinal Cord Stimulation System, investigated the NeuroSense feature designed to reduce overstimulation sensation in patients with chronic pain.
Requirements: Participants underwent a spinal cord stimulation trial phase of up to 10 days. Only those achieving ≥50% pain reduction were eligible for permanent implantation.
Outcomes:
- Cognivus achieved strong recruitment and retention, ensuring continuity from trial to permanent implant.
- 100% compliance with GCP and precise data entry reinforced sponsor confidence.
- Robust collaboration with Medtronic enabled efficient monitoring and consistently high-quality follow-ups.
Nalu Neurostimulation System (NAL-01-2018-AUS)
Background: A prospective, multi-centre, open-label feasibility study by Nalu Medical, Inc., to confirm the performance and assess user satisfaction of the Nalu Spinal Cord Stimulation System in adults with chronic intractable leg pain, with or without back pain.
Requirements: Permanent implantation of up to 40 subjects across 10 centres in Australia and New Zealand. Eligible participants were aged 21–80 with chronic neuropathic leg pain (≥6 months), unresponsive to conservative treatment, and achieving ≥50% pain reduction during a 3–30 day trial phase.
Outcomes:
- Cognivus met recruitment targets and ensured participant compliance through effective trial-to-implant support.
- Accurate, timely data reinforced sponsor trust in site reliability.
- Strong collaboration with Nalu Medical demonstrated Cognivus’ capability in managing device-based trials seamlessly.
SPMC-002 Study
Background: A single-centre, prospective, open-label study by Cognivus Research Group, evaluating high-frequency (10 kHz) spinal cord stimulation in patients with chronic chemotherapy-induced peripheral neuropathic pain (CIPN). The study hypothesised that this therapy would provide clinically meaningful improvements in symptoms, functional limitations, and quality of life.
Requirements: Permanent implantation of 20 patients. Participants had CIPN for at least six months post-chemotherapy, were in cancer remission, had VAS pain ≥6/10, failed conventional management, were on stable analgesic regimens, over 18 years old, and suitable surgical candidates.
Outcomes:
- Cognivus successfully recruited and permanently implanted eligible patients, achieving study objectives.
- Data integrity was safeguarded through strict adherence to GCP, SOPs, and rigorous monitoring.
- High-quality follow-ups, timely data entry, and smooth execution reinforced sponsor confidence.
SALIENT Study
Background: A Phase I/II, multi-centre, randomised controlled trial sponsored by SpineThera Australia, evaluating SX600 for pain relief in patients with painful diabetic neuropathy. The study aimed to assess safety, tolerability, and efficacy compared with placebo.
Requirements: Enrolment of adult participants with painful diabetic neuropathy, with rigorous safety and pain assessments, alongside strict compliance with follow-ups and data entry.
Outcomes:
- Cognivus successfully screened and enrolled eligible patients with efficient recruitment timelines.
- 100% compliance with GCP, SOPs, and sponsor protocols ensured high-quality, audit-ready data.
- A strong sponsor relationship facilitated efficient monitoring, rapid query resolution, and confidence in site performance.
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