Interview with Ashley Hunter
The role of a Sr. Director of Clinical Operations and Delivery
“Our mission is to always be an extension of our sponsor team and not act as a separate entity, a true partnership.”
What is your job position and how would you define it?
I am a Sr. Director of Clinical Operations and Delivery and I head up the Strategic Development and Delivery team. My role within Strategic Development is to provide our sales team with consultative support to potential and existing clients. In turn, I develop a strategy for solutions that will optimize the likelihood of their trial being successfully conducted within the timelines and budgets that they have set.
When does your expertise come into the product’s life cycle?
Our area of expertise comes into play late-stage pre-clinical so getting sponsors and biotech companies, pharmaceutical companies ready to take that drug into the clinic for first-in-human trials and we can support them all the way [through post-marketing and real-world evidence through post-marketing and real-world evidence.
What is Aixial’s area of expertise?
Aixial has been providing support to biotech and pharmaceutical companies for more than 2 decades. We have expertise in Project Management, Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Safety, Medical Writing, and Regulatory Affairs. Our core area of focus is Oncology, Rare Diseases, Radiopharmaceuticals and Cell and Gene therapy. Over the last 20+ years, we have successfully delivered over 1,500 clinical trials across 24 therapeutic areas.
Why are CRO’s important in the clinical research industry?
Throughout the years, there have been a number of surveys that have been conducted in the industry asking that very question and time and time again the results show that CROs can improve trial efficiencies and increase productivity and the quality of the trials that are delivered. Because we are specifically focused on clinical trial delivery, we bring a vast amount of knowledge to the table that really helps to optimize and deliver the trial in the most efficient manner. There is also an economical aspect and cost efficiency in using CROs to support clinical trials. We are able to deploy resources on a flexible scale meeting the needs of our sponsors, so flexing up, and flexing down when they need us to help support their clinical trial delivery.
How is Aixial Group staying at the forefront of the innovation?
Our people are what drive innovation. At Aixial, we have over 1,000 team members that are experts in their role and their functions. It’s with the input of our subject matter experts, that we are able to face adversity and challenges together and come up with a winning solution that will support our sponsor’s goals but most importantly will benefit the patients that are participating in clinical trials.
“Our people combined with our technology is what positions us to successfully deliver clinical trials and keeps in the forefront of innovation.”
Ashley Hunter, Sr. Director of Clinical Operations and Delivery
Second to our people, is our technology. We have a large suite of technological solutions to meet the needs of our sponsors, based on the size, complexity, and reporting needs. This includes a variety of systems for clinical reporting, clinical data reporting, safety data, regulatory reporting, and statistical reporting, as well as CSR delivery. In addition to this, we have strong experience to support decentralized trials with the use of technology for eConsent, ePRO, and also wearable devices for safety monitoring.