Innovative IRT Solutions: Almac’s Commitment to Clinical Trial Quality and Innovation in APAC

Joseph Goh

Design Manager – 系统设计经理 | Almac Clinical Technologies

Introduction 

My name is Joseph, and I have been a Design Manager at Almac for almost eight years. I began my journey in Singapore, where I am originally from, but I have been based in Japan for over two years now. 

The Secret Behind Changi Airport’s Success 

As a Singaporean, I am proud of our world-class Changi International Airport, which has won top honors 12 times, including consecutively from 2013 to 2020. Achieving such success is not easy. One reason is the enforcement of high-quality, process-driven services. For example, Changi Airport customizes solutions and partnerships with airlines instead of using a one-size-fits-all model. This enables Changi Airport to drive air traffic and connectivity, maintaining its status as a premier air hub. The airport’s vision includes delivering the unique Changi Experience—a personalized, stress-free, and positively surprising journey. This means that airport facilities are constantly improved, renovated, or newly built to surpass customers’ and passengers’ expectations. This culture of excellence has kept Changi Airport as the top airport for many years. I share this success story to draw a comparison to why I believe Almac has remained one of the top IRT vendors in this field.

The True Value of IRT Systems 

In today’s world, IRT systems are constantly adding new features, functionalities, and boast fantastic-looking UIs. While these are important, how many features can we add? How robust should an IRT system be? And how cutting-edge should a UI look? While these features are now ubiquitous amongst IRT providers, a key differentiator that separates us from our competition is the process, service, and support that we can offer.

Quality Starts from the Design 

When I started as a Design Manager (DM), I was told the learning curve could be steep.  As the job involves detailed planning, quality design standards, and control. As a DM, we are well-trained to read and understand the study protocol to provide the best IRT design. New DMs are assigned a mentor for at least six months, receiving guidance from senior DMs during their first few studies. Just like how Changi Airport customizes solutions and partnerships with airlines, we engage in detailed discussions with clients to customize the system based on their study needs. There is no one-size-fits-all solution. 

After discussing requirements with the client team, the design goes through two rounds of review—one through a requirement presentation to the Group Leader (GL) and Technical Service Leader (TSL), and another detailed requirement review. If any requirements are not up to par, the design managers must improve the design based on the reviewer’s comments. Due to stringent quality controls, this can translate into a substantial amount of work to be done within a short period. I did lose some sleep because of such high demands. However, these are to ensure the designs are of the highest quality before client sign-off.

Not Just Typical Project Managers 

When the APAC team first started out, DMs like us also held a hybrid role as PMs. We often joked that project managers (PMs) are our first and last line of defense. We were the first to receive the sometimes-difficult demands from our clients, and the last to enjoy the fruits of our work. PMs are the ones who hold and gel the team together, ensuring outstanding items are addressed timely, timelines are kept in check, and customers are kept happy. 

PMs need to know how to interpret client expectations and require certain skills to read between the lines. Our PMs have years of experience and are skilled in client management. They build good relationships with the study team and have a solid technical knowledge of IXRS.  Years ago, during one of the Investigator Meetings in China, I was presenting the IXRS section, and during the Q&A session, a question pertaining to drug supply was brought up. While I was answering the question, I mentioned the client’s internal standard which was not part of the scope of IXRS. During lunch, the client study manager expressed to me that he was impressed that an Almac PM was able to provide such detailed replies to the participants.

Collaboration and Support in Development and Testing 

Sometimes when I chat with our developers, they share that as developers, they do not work alone. From the start, a TSL is assigned to provide technical support and consultation. Code reviews are also done by TSLs to ensure complex or high-risk sections are properly and efficiently coded. Our testers then heavily test those codes, who are also assigned a GL for support and consultation. Features that do not pass testing will have bugs raised through a proper system to ensure resolution. During development and testing, DMs like myself, developers, and testers maintain constant communication to address any issues or improvements needed for the design.

In these eight years, thankfully, I only have a handful of studies that were considered highly complex. I remember one study that involved chemotherapy treatment, which had multiple titration rules and different combinations of chemotherapy options that impacted the visit schedule. The challenge for us was to make such a highly complex study simple to navigate and operate for the site users. During the development of that study, the developer had to explore different ways of coding to ensure the system could perform visit schedule switches along with the different chemotherapy. We also came together to discuss the different test scenarios and adjust the design accordingly to ensure the system was free from bugs. We too want to surpass the client’s expectations and give them a pleasant, worry-free experience using our system, just like what Changi Airport does.

Quality Assurance: You Shall Not Pass? 

When all development, internal testing, and UAT are completed, what stands between the system go-live is our outstanding team of Quality Assurance Analysts (QA). Holding the quality gate, QA analysts ensure that proper documentation, development tasks, and test case reviews check all the QC boxes. Any missing component will not pass the stringent QC process. Every checkbox must be checked. 

Our QA team goes beyond acting as a gatekeeper for our development. We also have an Incident Report (IR) team that meticulously investigates any quality incidents, providing detailed reports on the causes and devising Corrective and Preventive Actions (CAPA). Their work helps us continuously identify shortcomings and improve our processes. 

Of course, we must acknowledge our audit team, who play a crucial role in supporting audits and inspections. Whether it is a regulatory audit or a client request, our audit team consists of highly specialized staff who coordinate all documentation and interview requests. They ensure that audit inspections are conducted properly, documents are provided accurately, and all requests are meticulously tracked and documented. Their importance in helping us keep up to date and aligned with regulatory guidelines cannot be overstated.

Our Own Team Success Story #1 

In 2020, the pandemic broke out, causing significant challenges for several studies in China due to strict lockdown measures. As cities were under lockdown, it became difficult to provide drugs to patients, with hospitals also being inaccessible. One of our clients reached out to our Project Managers (PM), seeking ideas or solutions for this extraordinary situation. The PM organized a meeting with the client and included a consulting Design Manager (DM) to discuss potential solutions. 

During the discussion, we concluded that the only viable option for the client’s operations was to ship the drug directly from the depot to the patient. Some studies were more complex, especially double-blinded studies involving numbered kits. Fortunately, it was an open-label (OL) study with non-numbered kits, allowing us to quickly devise a workaround. The process involved the drug supply manager moving the drug from the depot to the site using the adjust inventory feature. The site would then perform the visit transaction for the subject. Once completed, the site would request a specialized clinical logistics company to collect the drug from the depot and deliver it directly to the subject. With this workaround, we ensured that patients continued to receive their doses, and the study progressed smoothly without any further interruptions. 

Although the workaround was simple, the meeting lasted over an hour as we needed to understand the client’s operational restrictions to provide the best solution for both the client and the patient. This pandemic level was unprecedented for everyone involved. However, using this experience as a learning opportunity, we enhanced our system by adding a “Direct Depot-to-Subject Visit Assignment” functionality.

Our Own Team Success Story #2 

Years ago, during one of our studies, a kit type that was being replaced, which was not brought to the attention of the IRT project manager. The new kit type had a different volume, affecting the actual quantity to be assigned. This required the system to assign a new kit type code and a system amendment to update the kit assignment logic. The situation was complicated by the fact that there were about five to six patients waiting for randomisation, and the transaction could not proceed because the new kit type could not be assigned. Given the difficulty in recruiting patients for this study, the client was keen to avoid turning them away. 

Our PM called for a meeting with the client, and our team began working on a solution. By referencing the study randomisation records, we arranged a work around to have the subjects randomised until the system could be updated. Together with the client’s drug supply manager, we also assessed any subsequent drug dispensations that would be impacted, and came up with a mitigation approach, to avoid interruption in subject treatment. Our QA team ensured that these processes and deviations were properly recorded, documented and any potential regulatory concerns were addressed. This way, even in the event of an audit check, we could be confident that the process did not compromise the study’s integrity. 

While these processes were ongoing, we quickly assembled a team for an emergency build release and worked tirelessly around the clock. Once the release went live, data in the IXRS was accurately injected to match all transactions. The entire process of adding the new kit type assignment logic and going live took less than a week, without compromising quality. All subjects were treated correctly, data integrity was maintained, recruitment was unaffected, and all unblinding information was securely preserved. While we do not consider ourselves superheroes, during that week, many of us felt like we were wearing study-saving capes.

Conclusion 

Finally, I would like to share some words from several client study managers: 

• “Compared to another vendor, we felt much more secure entrusting this study with Almac.”
• “The knowledge you have of our internal processes was a pleasant surprise. This shows the quality of Almac.”
• “Any study with Almac IRT is worry-free. UAT is the smoothest sailing compared with other vendors.” 

These testimonials from our valued customers are a tremendous encouragement to us. The success of both Changi Airport and Almac is built on a shared commitment to quality and continuous improvement. Changi Airport’s excellence in the aviation industry and Almac’s unique approach to development processes ensure we deliver reliable IRT solutions. 

Our process is distinctive in its meticulous understanding of client needs, rigorous multi-layered quality control, and a culture of open communication and continuous learning. These unique elements are integral to our operations and have earned us the trust and loyalty of our clients. As we continue to innovate and uphold these high standards, we are confident in our ability to provide exceptional service and maintain our leadership in the field. For more information regarding Almac’s APAC IRT Regional Capabilities and for more information on our commitment to delivering quality services to our customers, visit our website: Almac’s Asia-Pacific (APAC) IRT Regional Capabilities