The idea that clinical trials demand flexible solutions is not novel. However, defining how that flexibility is delivered may be. One of the most effective ways to offer substantial flexibility is to present different approaches to study builds. The Mednet Technical Project Operation (TPO) team has developed a reliable study build methodology that enables customers to build their studies or contract with Mednet to build them. In either scenario, the collaborative approach ensures the quickest path to success.
Customer Study Builds
As described in our previous blog, there are a variety of factors research teams need to consider when determining whether to build studies on their own or have Mednet build for them. Mednet customers who decide to build their studies may require different levels of support. In most cases, Mednet recommends each designer use the iMednet Learning Management System (LMS), a library of online courses including hands-on videos, documented best practices, and comprehensive designer guides. As part of this training program, Mednet assigns a LMS mentor from the TPO team to guide the new designer(s), providing feedback and practical assignments to reinforce user learning. This collaborative process combines digital and human interactions to accommodate different learning styles. After completion of the training program, the learner will have a solid understanding of how to build studies in iMednet. Sometimes, a client may choose not to require their designers complete the LMS courses. In these instances, designers can still choose to have 24 x 7 access to the LMS to support their learning needs on demand.
Upon completion of the LMS courses, Mednet offers additional support through a Mentor Build Program. In this program, Mednet assigns an experienced member of the Mednet TPO team as an iMednet mentor. The mentor regularly meets with the customer designer team to help educate and guide them through the process. During this interactive learning process, the customer designer builds and validates their first study, with the support of the iMednet mentor. Regular meetings are conducted where the mentor provides guidance to designers regarding next steps in the build process, while also reviewing and answering questions regarding previous build work. Teams who are well-versed in electronic data capture (EDC) tools and processes may opt for a partial mentor build, or they may choose to opt out of the mentor build in full depending on their previous experience.
Once the team has successfully built their first study, they can continue to access the LMS and supporting materials. They can also reach out to the Mednet Core Support Team, which consists of implementation consultants with strong technical expertise.
In both customer build scenarios, the Mednet support model shifts to accommodate the customer situation and their clinical trial goals.
Mednet Study Build
There are also cases where customers choose to have Mednet build their study for them. Though the requirements shift, the level of support and the degree of care and attention does not change. The Mednet Study Build is also an interactive process that is driven by the customer’s unique needs.
Once a customer contracts with Mednet to build their study, the Mednet TPO team arranges the initial requirements discussion. This is a very collaborative engagement. The team leverages their prior category / therapeutic area expertise along with worksheets and best practices gained from previous studies to guide the conversation and define the specifications for the study.
The Mednet team uses the output from this meeting as the foundation to build the first study wireframe. Customers typically participate in two review cycles. This iterative process allows for changes to the build. It also helps customers transition their thinking from paper case report form (CRF) models to true electronic data capture. As this organic transition happens, the advanced study build emerges for review. Once the review is complete, the build is validated and goes live.
Mednet designed the entire study build as an agile process that infuses flexibility. This methodology enables the Mednet team to work swiftly and efficiently. In fact, in most cases, customer availability is the most significant driver on study build timelines. We also take advantage of CDASH compliant templates and forms in this agile process to increase productivity and offer greater efficiencies to customers.
Hybrid Study Build
Some customers opt to have Mednet build their first study or two with the ultimate goal of bringing future study builds in house. This approach allows the experienced Mednet team to create template studies the client can use to replicate from, providing clients a great start on their future study builds. It also enables the customer to really see what iMednet can do from a birds-eye view, and it provides an opportunity to understand what their end users might want to see before they attempt to build studies on their own. The iMednet platform is robust with many configuration options, so it can be quite helpful for research teams to have a deeper understanding before they dive in and build a study. This approach enables the team to develop confidence and comfort with a new system and processes. It permits a phased approach for user adoption and empowers users to learn while minimizing risk.
The Mednet team has designed and invested in a flexible support model that enables clinical research teams, regardless of the study build path they choose. We understand that each team has unique needs, and we’ve implemented a support model that acknowledges these differences while enabling them to move quickly and efficiently.
If your team is contemplating whether to build your next study or needs additional support, please contact us. We can walk through the alternatives and help you make the best decision for your team.