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.

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

iNGENū CRO collaborates with experienced surgical teams, anaesthesiologists, and perioperative care specialists, ensuring robust trial design, meticulous execution, and comprehensive data analysis.

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 

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.

Ensuring patient safety during trials that include surgical interventions requires vigilant monitoring and immediate response capabilities.

iNGENū 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.

Differences in surgical techniques across sites or surgeons can introduce variability in outcomes, complicating data interpretation.

iNGENū 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.

Accurate and consistent measurement of pain, sedation levels, and anaesthesia-related outcomes can be challenging due to their subjective nature.

iNGENū 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.

Maintaining patient engagement during postoperative follow-up, particularly for extended recovery periods, is critical but challenging.

iNGENū 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

iNGENu - FDA
Local Trials, Global Approvals

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Our seamless integration allows trial data from Australia to be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENu - cost efficient
Disciplined, Cost-Efficient Execution

iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes. Our trials are designed with efficiency in mind, eliminating unnecessary costs while maintaining the highest scientific and regulatory standards.

iNGENu - APAC
Australian-Headquartered, Asia-Pacific Reach

We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless combination of cost-efficiency and high-quality clinical trials. We leverage the region's competitive pricing while maintaining rigorous Australian-based project management and clinical oversight.

"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.

We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."

Giles Moss
Chief Executive Officer

iNGENu testimonial-logos-monotone-1

Ready to discuss your Perioperative Clinical Trial?

 

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