FULL SERVICE SUPPORT
ENT Clinical supports clients throughout their clinical development program; from defining clinical strategy, target population and trial design, through to regulatory submissions, trial set up and training of local staff and to expert monitoring and DSMB reporting. Our clinical and statistical experts and specialist data management systems will ensure high quality and timely analysis, interpretation and reporting of your trial data; offering a Full-Service Solution.
- Clinical strategy advice
- Target population identification
- Clinical trial design
- Site identification and feasibility assessment
- Regulatory submissions
- Site set-up
- Clinical trial delivery
- Project Management
- Local staff training
- Site management & monitoring
- DSMB reporting
- Data management
- Statistical analysis
- Trial data interpretation
- Trial data reporting
Scientific input and consultancy
We are well versed with and support all therapeutic approaches for inner ear and central auditory disorders, including drugs, genes and cells for optoprotection, restoration and regeneration.
We provide expertise for the full range of lead indications in ENT, Hearing & Balance, including drug and noise induced hearing loss, mono and multigenic conditions, age related hearing loss, as well as tinnitus, central auditory processing and balance disorders.
We work with clinicians who are familiar with all therapeutic delivery approaches to the inner ear and central auditory pathways: from systemic administration and local delivery through drops, sprays and intratympanic injections, to surgical approaches via a cochlear implant or delivery device. More importantly, we can effectively implement our clinical and scientific knowledge to your trial design and development and advise you in using biomarkers and imaging.
Patient recruitment
We provide expertise in recruiting adult and paediatric patients from public and private hearing services across a range of healthcare systems. We work with sites and settings outside traditional hearing services to recruit patients (at risk of) hearing loss, and have a network of oncologists and respiratory physicians with an interest in ototoxicity, as well as geneticists, primary care and community physicians keen to provide their perspective on hearing loss and to test new hearing treatments in their patients.
Operational excellence
We have hands-on experience in the development and delivery of investigator led and commercial early and late phase trials of novel hearing therapeutics, hearing devices and complex interventions in ENT, Hearing & Balance. Together with our committed network of academic leaders and investigators around the world.
Professional collection, handling and storage of your hearing data
Experienced clinical data project managers coordinate key activities and manage study data flow, ensuring that data are collected, handled and stored accurately and appropriately. In addition to regular data management tasks, efforts are made to add value to clinical research projects by leveraging the available information for project management and compliance, in order to facilitate the use of central and risk-based monitoring approaches.