Perioperative
Perioperative Clinical Trials require careful orchestration across multiple phases of patient care, from preoperative preparation through intraoperative management to postoperative recovery.
Trials in this specialty must navigate unique challenges, including complex patient management, safety monitoring during surgical procedures, and coordination among multidisciplinary teams. At iNGENū CRO, our expertise ensures high-quality, compliant, and efficient trials that advance perioperative medicine. iNGENū CRO collaborates with experienced surgical teams, anaesthesiologists, and perioperative care specialists, ensuring robust trial design, meticulous execution, and comprehensive data analysis.
Our team has significant experience in the design and execution of trials across various perioperative domains, including:
- Enhanced Recovery After Surgery (ERAS) protocols
- Novel analgesics and anaesthesia techniques
- Surgical site infection prevention
- Hemodynamic management
- Thromboprophylaxis
- Postoperative nausea and vomiting (PONV) management
Disciplined,
Cost-Efficient Execution
while maintaining the Highest Quality
Local Trials,
Global Approvals
Access FDA Regulatory Expertise
Our Clinical Team has over
120
years
of Combined Clinical Trial Experience
Addressing Common Pain Points Associated with Perioperative Clinical Trials
Complex Coordination Among Multidisciplinary Teams
Problem:
Perioperative trials involve coordinating various specialists, including surgeons, anaesthesiologists, nursing staff, and rehabilitation experts, which can be logistically challenging.
iNGENū CRO addresses this pain point with Integrated Trial Management:
We utilise integrated trial management systems and clear communication channels to ensure seamless coordination among multidisciplinary teams. Regular team meetings, standardised protocols, and defined responsibilities enhance operational efficiency and collaboration.
Patient Safety During Surgical Procedures
Problem:
Ensuring patient safety during trials that include surgical interventions requires vigilant monitoring and immediate response capabilities.
iNGENū CRO addresses this pain point with Advanced Safety Monitoring Systems:
Our trials incorporate state-of-the-art monitoring technologies and real-time data analysis. A dedicated safety oversight board provides continuous review, allowing rapid intervention in response to adverse events, ensuring patient well-being throughout the perioperative period.
Variability in Surgical Techniques
Problem:
Differences in surgical techniques across sites or surgeons can introduce variability in outcomes, complicating data interpretation.
iNGENū CRO addresses this pain point with Standardised Surgical Protocols:
We develop standardised surgical protocols in collaboration with leading surgical experts and ensure consistent training across all trial sites. Centralised data review processes further minimise variability and enhance data reliability.
Managing Pain and Anaesthesia Outcomes
Problem:
Accurate and consistent measurement of pain, sedation levels, and anaesthesia-related outcomes can be challenging due to their subjective nature.
iNGENū CRO addresses this pain point with Objective Measurement Tools:
We employ validated pain and sedation assessment tools alongside advanced monitoring devices (e.g., depth of anaesthesia monitoring). Our team provides comprehensive training to clinical staff on the consistent application and interpretation of these tools.
Postoperative Follow-up and Patient Retention
Problem:
Maintaining patient engagement during postoperative follow-up, particularly for extended recovery periods, is critical but challenging.
iNGENū CRO addresses this pain point with Patient-Centric Follow-up Approaches:
Our approach includes flexible scheduling, remote follow-up options, and digital patient engagement tools to ensure high retention rates. Continuous communication, education, and support help patients remain committed and compliant throughout the trial.
The iNGENū CRO Difference
Local Trials, Global Approvals
We uniquely combine Australian expertise with direct FDA submission capabilities.
Disciplined, Cost-Efficient Execution
iNGENū CRO takes a highly strategic approach to clinical research.
Australian-Headquartered, Asia-Pacific Reach
We provide sponsors with comprehensive trial capabilities.
We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have been very happy with all aspects of the management of the clinical trial.
Ready to discuss your Perioperative Clinical Trial?