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As discussed in our last blog, we see three BIG trends impacting clinical trials and how they are conducted. As the clinical trials industry rapidly evolves, we anticipate these trends to not only continue, but potentially grow, in the foreseeable future. They are:

  • Adaptive trials
  • Data Standardization
  • Increasing Complexity of Clinical Trials

As we continue to monitor and analyze these trends and the accompanying new requirements, we wanted to share how we are approaching them from a product strategy perspective.

In support of adaptive clinical trials, we have listened closely to our customers, particularly those working on oncology trials which are often adaptive design trials. With new sources of data, improvement in analytics and advances in science, cancer research is growing rapidly and is an ideal place to apply adaptive trial design.

In these types of trials, patient follow-up, treatment and management are non-linear activities. Tracking and managing incoming data in a traditional eClinical solution would require fragmented data entry and multiple access points. The iMednet patient record page offers a clear and concise visualization of the protocol assessment. It graphically depicts what data has been collected and what still needs to be collected. As patients participate in the trial, respond to treatment, change dosing, increase or reduce visits, staff can see the real-time view of the data they have and the data they need and can respond accordingly. This enables site staff to prioritize activities and increase efficiency and helps monitors to provide greater oversight with less effort.

From the data standardization perspective, we have continued to align our development strategy with CDISC data standards. Though the standards are more strongly entrenched for pharmaceutical and biotech products, we also track those emerging standards being developed to support medical device trials.

Clinical Data Acquisition Standards Harmonization (CDASH) is a CDISC initiative that defines basic standards for the collection of clinical trial data. In iMednet, users can build CDASH compliant forms. In addition, our form libraries enable clinical trial teams to create and reuse therapeutic area specific forms. Once a team has invested the time and energy in configuring iMednet, they can define study templates that allow them to quickly and easily replicate custom dashboards, workflows and roles. These types of reusable elements throughout the system add ongoing efficiencies to current and future study set-up activities. They also allow teams to share and benefit from therapeutic area expertise, experiences and best practices.

Finally, we know it is imperative to address the increasing complexity that is overtaking clinical trials. There are many different factors that are contributing to the increasing complexity. It is an often-discussed aspect of clinical trials in conference presentations and industry journal articles. The iMednet guiding principle in our product strategy is to SIMPLIFY the user experience. This continues to be a driving force behind our unified platform, because we understand the importance of protecting the user from complex tasks that can become bottlenecks in the trial process. From our comprehensive and easy-to-use study build tools to the intuitive navigation, we make clinical research easy, fast and efficient.

When built with native modules, a unified platform approach ensures that trial team members have consistent experiences and that powerful automation is available wherever it is needed. This intentional design often stands out to users who have experience with other platforms that have evolved from acquired or “bolted-on” modules. The challenge of inconsistent interfaces and patchy functionality add complexity to an already complex process. Our unified platform approach delivers a seamless experience and is designed to address complexity with simple, flexible solutions that add efficiency – not complexity – to clinical research.

Though our product strategy continues to evolve, we are committed to staying ahead of the curve on important aspects of clinical trials. This means we will continue to lead the industry with solutions that address the challenges of adaptive clinical trials, leverage data standardization initiatives and continue to chip away at the increasing complexity of clinical trials. To learn more about how to choose the right eClinical technology, check out, “Choosing an eClinical Solution Ready for the Demands of Tomorrow”.