Almac Clinical Technologies (ACT) is one of five business units within the Almac Group, an established contract development and manufacturing organization. Where does ACT fit in?

Almac Clinical Technologies, headquartered in the United States, provides our biopharmaceutical partners with innovative software and professional service solutions to simplify the management of the most critical elements in clinical trial conduct. More specifically, ACT designs and deploys complex software that helps trial sponsors automate complex decisions that occur in clinical trials – such as randomization, patient dosing, titration, eligibility/enrollment criteria from 3^rd party centralized laboratory tests, and medication inventory management. Many of these functions are combined as part of a web-based software system commonly known in the industry as ‘Interactive Response Technology,’ or IRT for short. As a member of the wider Almac Group, our capabilities augment and complement the core functions of Almac’s Clinical Services division in terms of packaging, labeling and distributing clinical supplies.

What are some of the biggest hurdles faced in clinical trials in terms of compliance?

The biggest challenge that the industry faces is keeping abreast of potential shifts in the regulatory landscape. Our clients consistently depend on us to advise on the implications of specific regulations. For instance, while oversight of temperature-sensitive clinical supplies, or “cold chain,” has always been important, the regulations have now changed to require monitoring of all supplies, including ancillary and room temperature supplies. As a result, Almac has created a product called TempEZ™ which tracks and monitors all clinical trial supplies with a particular focus on ensuring product stability and optimal temperature are maintained. This area of oversight is becoming more crucial by the day, especially as we see the biopharmaceutical landscape shift focus from small-molecule compounds, to large-molecules (biologics) that are extremely expensive to produce.

Another area of focus is the challenge of data privacy as the use of cloud and encryption technologies increases. Traditionally, the pharmaceutical industry has been slow to change, but there is currently a greater need and financial pressure. Because of developments in healthcare and pressures around costs, companies and the industry at large are accepting change at a more aggressive rate than I have seen in my 20 years in the industry.

Could you elaborate on Almac’s IXRS Technology and its advantages?

IXRS® 3 focuses primarily on randomization, drug assignment and maintaining the blind in a clinical trial. Over the years, the platform has grown to automate dosing decisions and titration decisions, thereby improving data integrity over manual processes which can be subject to suspicion. We also now bring in a more global and broad supply management possibility. Unlike virtually all of our competition we do not rely on acquisitions for new technology systems; we build them internally using our own expertise.

Almac’s IXRS® 3 is also the only Interactive Response Technology system available on the market today that has the ability to perform a complete accountability and reconciliation of clinical trial supplies after they’ve arrived at the clinical site. Couple this with TempEZ™, which has the stability data, and we can account for all supplies at all points in the supply chain. We looked at over 200 studies across various sets of criteria, half of which used Almac’s solution, and found that there were consistently less drug shipments, 40% less on average, when companies engaged us for both IXRS® and clinical supply management & distribution. Shipments cost millions of dollars, so there are a lot of savings to be made, particularly for larger trials. Our ability to tailor and customize solutions distinguishes Almac Clinical Technologies from other technology proprietors. A one-size-fits-all approach simply does not work.

What are the core motivations behind the establishment of the Almac Clinical University?

Across the industry we have found that there is no place to share thought leadership or knowledge, especially relating to the niche of what we do in supply management. The market component offers a forum to share knowledge by posting white papers, presentations, and so on. In addition, there is a specialized component for our customers. If a client’s internal processes, workflows or systems function differently from the standard, we will tailor an eLearning curricula to acclimate users of the IXRS® on how best to perform specialized functions. We provide interactive training and certification to ensure comprehension and retention in the event a regulatory agency requests it.

What do you see as the major challenges for the industry in the short term and how should they be addressed?

By their very definition, clinical trials are high-risk. There is no room for error, whether in patient randomization or in the assignment of a product kit or dose. The supply side is equally critical and is becoming increasingly important due to the costs associated with costly investigational products, like biological compounds. These compounds are more difficult to make and caution is required to ensure adequate supply to conduct trials, while minimizing instances of superfluous shipments. Clinical site selection and retention are becoming increasingly important, and we are focused on providing visibility and analytics in these areas to aid success.

The industry needs to work together in a cross-functional manner to drive speed, efficiency and cost in trials. We have seen some fresh thinking in the industry at a leadership level, and companies are coming together to share their knowledge and experience to create industry standards across countries, like the TransCelerate initiative. These types of broad-reaching consortiums are well poised to drive meaningful change in an industry which has historically been risk-averse and slow to implement new solutions.

How does Almac plan to develop its services going forward?

Our focus has always been on reducing complexity in as many aspects of clinical trial conduct as possible. We have significant efforts to include the perspective of the clinical site more – improving the usability of their workflow, which in turn helps trial sponsors to retain their preferred sites. We are developing new forms of automation like barcode scanning instead of manually inputting kit numbers for accountability logs, which saves time and reduces instances of human error. We are also looking at leveraging our data, another big industry trend, to produce unique analytics to help our clients stay informed and enable them to make smarter decisions at high-cost inflection points. Any area in which there are frustrations or pain-points is where Almac Clinical Technologies will look to innovate.