Advanced Clinical

Tim Jackson

Perks of Cloud in Biotechnology

If a firm is NOT using the cloud, they are missing important functional gains and substantial cost savings. The benefits of cloud computing are just as valuable for the life sciences/ biotech industry as they are for other industries. Of course, the mix between using a pure SaaS or public-private hybrid cloud solutions for a life sciences firm will be different than an auto parts manufacturer, but there are common approaches for biotech foundational business processes. For example, sales, marketing, financial operations, and HR functions could be cloud deployments for any firm. Only in regulated clinical operations is there more of a bias to on-premise solutions, however, even in clinical operations, there are plenty of cloud alternatives such as cloud-based EDC and electronic Trial Master File (eTMF) solutions. Our own Clinical Trial Management System (CTMS) is a proprietary solution that we host in our private cloud.

The Impact of IoT on Biotechnology

For biotech and healthcare in general, the Internet of Things (IoT) themes are really not that new. In life sciences, IoT means enabling instruments, patient sensors, and clinical professionals with technology that allows data to be captured once and at the source. That is the promise of IoT. Healthcare has been chasing these goals for years. So at some sites, when patient results are measured bedside or from a lab system, the data is captured once and automatically transferred to the Electronic Health Record (EHR) and then to the Electronic Data Capture (EDC) system.

"Research identifies that the marginal dollar spent on business process automation and BI/analytics are far more valuable than adding to or supporting legacy systems."

The Technology Requisites for Biotechnology Enterprises

I see five strategic technology needs for clinical operations in the next few years.

1. First is the proper deployment of Risk-Based Monitoring (RBM) solutions. RBM's adoption will transform the study monitoring function. As tech leaders, RBM solutions present us with two large challenges. The first is to cost effectively integrate our clinical systems with our RBM solution. The second is to help our teams really challenge themselves to call out the right mix of Key Risk Indicators (KRIs). Only with effective KRIs will the investment in the RBM solutions be realized. Our own RBM work has highlighted this factor when we look at how much time we spend on defining and building the right mix of KRIs for a study.

2. Next is the need for better security tools. We spend a lot of time and money ensuring whether our systems are secure. My concern is that the conventional wisdom is wrong, or at least not optimal, for a clinical data center. To clarify, the conventional wisdom is that layered defenses and encryption are best practices. Essentially that means there is a heavy reliance on threat containment after a penetration. That may work for a commercial enterprise, but, in the context of clinical data, we need better defenses on the perimeter.

3. The third strategic need is for faster development, adoption, and use of industry standards within clinical systems. We know the inherent complexity and variation in clinical studies creates a heavy design burden on standards. Building standards for how data is structured and the fundamental business processes of a study including study design and protocol, EHR and lab integrations, Case Report Form (CRF) development, data collection methods, data analysis, RBM, and reporting and submission, need to be incorporated into technology systems. 

The value of standards is clear to everyone, but time is of the essence. We know there is direct correlation between advances in standards and improved interoperability which in turn reduces costs and complexity.

4. The fourth strategic need is an increased use of mobile solutions. Mobile technology in clinical operations lags behind general commercial applications. The security, standardization and validation demands are higher for clinical trials, but can be engineered into a mobile application. The productivity and quality gains from moving clinical operations technology closer to the data discovery on a more real-time basis to the moment of the data discovery (from monitoring activities, to patient enrollment, to safety investigations, etc.) will increase response time and reduce the need for data transcription or transformation.

5. Last is the need for more workflow automation. Advanced Clinical has seen a dramatic increase in productivity from applying business process automation to the clinical monitoring process. Within our CTMS, we define studies and the key actors. The CTMS makes available automated workflow that facilitates site preparation, first patient visits, interim visits, exception handling with complete electronic signatures, calendar views, audit trails, reporting to the eTMF and task notifications. If a firm is working with a complex legacy system, don't miss the opportunity to look at some of the newer workflow tools that securely integrate with legacy systems.

Transitions in the Contributions  of a CIO

I see my role as a technology leader better described as a leader of digital transformation. The key to the role is: (1) forging a strategic alignment between business strategy and digital initiatives (2) building a faster and more agile culture, (3) spending smart, not more, on IT, and (4) creating the vision for IT to 'keep the trains running' while creating new client-facing and clinical operation capabilities.

Of those requirements, strategic alignment is by far the hardest goal to achieve but also the most important. Achieving this alignment requires building teamwork and trust on the leadership team, creating consensus on spending and priorities, coordination with business initiatives, managing risk, and building and managing an internal team.

Being fast and agile is the newest requirement. If your board or CEO hasn't challenged you for more development faster, then there is probably a disconnection. Fast and agile translates to faster decision making that balances strategy and tactics and is reflective of the view that sustaining status quo is a bigger risk than formulating and acting on a digital strategy.

Research identifies that the marginal dollar spent on business process automation and BI/analytics are far more valuable than adding to or supporting legacy systems. Advanced Clinical focuses on reducing the overall IT expenditure as a percent of revenue. We also focus on building BI and RBM, and using technology to automate workflow that connects clinical operations and business systems.

Creating a vision and managing a team to maintain current technology while creating new applications has always been an IT requirement. However, the pace of change and expectations for results have both increased each year. Therefore, we should challenge ourselves and our teams to be even more creative as engineers, project managers, process specialists, and business partners. Our continued success follows from that.

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