Hearing loss is the most prevalent sensory dysfunction in humans and recognised as major health, societal and economic burden and an area of unmet medical need. Recent scientific breakthroughs supported by growing private and public investments have facilitated a pipeline of novel hearing therapeutics, ranging from small molecule drugs to gene and cell therapies. As these therapeutics are advancing towards the clinical trial domain, specialist input to deliver proof of concept and to test safety and efficacy has become a priority to both scientists and industry.
Who we are
ENT Clinical is the academic clinical research organisation with the know-how and expertise to support your clinical development program in the hearing field. We do so by combining our clinical expertise and operational quality with specialist knowledge of the translational and patient pathways in hearing disorders, resulting in credible, creative, cost-effective solutions for clinical trials. ENT Clinical is embedded within Julius Clinical, an international science CRO with a long tradition of academic and operational excellence.
What we offer
ENT Clinical offers unique clinical trials expertise and services in ENT, Hearing and Balance disorders and a well-established international network of scientists and clinicians committed to the translation of hearing discoveries into treatments for patients.
ENT Clinical brings together expert insight in the latest developments in translational hearing research with excellence in clinical trial operations to effectively support your clinical development program. Our global and committed network of clinical academic leaders, guarantees access to expert sites and patient populations across the world.
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.
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.
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.
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.
Partnership and personal commitment
ENT Clinical and Julius Clinical’ senior leaders are actively involved in trial review, function as point of escalation and are committed in achieving timelines together with your allocated operational team. Internal and external communication lines are short and swift allowing for rapid problem resolution.
At the heart of ENT Clinical lies scientific expertise and operational excellence.
Chief Scientific Adviser
Anne Schilder is an ENT surgeon and trialist with over 25 years of experience in developing, conducting and leading clinical trials in ENT, Hearing and Balance disorders. She is a National Institute of Health Research (NIHR) Senior Investigator at the Ear Institute at University College London (UCL). She leads the NIHR UCLH Biomedical Research Centre’s programme of translational hearing research focusing on developing, trialing and implementing innovative hearing approaches in current hearing services. Her research ranges from first-in-man trials of novel hearing therapeutics (investigator lead and commercial, to late phase trials of common surgical and medical treatments in ENT, and from analysis of routine hearing health data to early health economic evaluation and clinical implementation of hearing innovations
She works closely with charities like Action on Hearing Loss and Fondation Pour l'Audition; patient and public involvement is at the heart of her research. As joint Co-ordinating Editor of Cochrane ENT, National Lead of the NIHR Clinical Research Network ENT Specialty and through her roles in international organisations like the International Society for Inner Ear Therapeutics, Anne plays a pivotal role in translational clinical research in ENT, Hearing and Balance in the UK and internationally.
Business Development Director
Tessa Kliest has obtained her research Master’s degree in Neuroscience and Cognition at Utrecht University, the Netherlands. Tessa started as a scientific network associate in 2017 at Julius Clinical, the company behind ENT Clinical, where she moved to business development to combine her passion for science with business. Her position at ENT clinical enables her to combine her scientific mind and expertise with her sharp eye for business opportunities. Her strengths lies in connecting different stakeholders varying from pharma, biotech to clinicians and scientists by discussing clinical development needs in neuroscience related topics with different in order to empower treatment and therapies for patients.
Hans van Dijk
Chief Operational Officer
Hans van Dijk
For over 25 years, Hans has supported the clinical development of novel therapies across various therapeutic areas. His experience covers the full range of clinical development from first-in man to global phase III cardiovascular outcomes studies. Hans has served as the Global Head of Cardiovascular and Metabolics at QuintilesIMS as well as Global Head of Regulatory and Start-up. Hans knows the challenges our Biopharma partners face and is keen to ensure that ‘ENT Clinical’ is truly invested in the success of our customers.