Avillion ensuring quality
Experienced and focused R&D professionals
The Avillion model incorporates highly experienced staff, dedicated to individual projects, who through robust training and oversight are able to accelerate trial programs whilst delivering a consistently high quality standard. Our experienced team have on average more than 15 years’ of industry experience and have held key R&D roles in pharma, biotech and CROs, collectively bringing a broad range of therapeutic expertise to Avillion.
The team includes medical doctors, biostatisticians, quality assurance professionals, regulatory experts, project directors, clinical project managers and clinical project administrators located in the EU, the USA and APAC. Our staff are assigned to lead and manage single trials or programmes, enabling them to provide focus and dedication, becoming intimately involved and familiar with every aspect of our projects.
Robust training and oversight
Training of staff at Investigator sites, CROs and other third parties is developed and delivered by our therapy area expert medics in collaboration with the assigned PM(s). This training is augmented through the Avillion team’s close oversight of all research activities, enabling the development and maintenance of strong relationships with trial Investigators through attendance at site initiation visits, conducting oversight visits of trial sites and directly supporting optimal management of patient care and adverse events.
The Avillion team pro-actively manages the CRO on a day-to-day basis, working to complement and practically support the CRO project team, essentially working as ‘one-team’. This joined-up ‘hands-on’ approach enables speed of execution, from optimization of study set-up and accelerated patient enrolment, through to high quality data outputs and compressed timelines from study initiation to clinical study report production, leading to a critically important overall reduction in the time to regulatory filing.
Quality assured timely results
Through our highly effective model, strong strategic partnerships and expedited delivery, quality is central to everything we do. Each trial has a bespoke intensive audit program developed and overseen by the Avillion Head of Quality Assurance and delivered by our network of specialist independent auditors. These programs include comprehensive audits of the CRO partner before and during the project, audits of third party suppliers, systems, investigator sites and targeted document quality reviews. Connecting into the trial quality management strategy and utilising ongoing study and quality metrics to ensure the audit program optimises oversight and delivers timely process improvement opportunities for the trial with the aim of mitigating risk and maximising quality.
Our overall approach is to ensure that each trial will be performed in the most efficient and expedited way possible, whilst ensuring the high level of quality required is achieved. To date this approach has led to a meaningful time saving of up to one year compared to the pharma partner’s expectations.