Choosing a clinical technology partner is a big decision. Identifying a partner that can enable you to build your studies as quickly as possible – and keep them on track – is critical for the success and timeliness of the clinical trial. A key decision for both sponsor and CRO research teams is whether or not to take on the responsibility for building studies. When working with Mednet, customers have the choice of building studies on their own or contracting with the Mednet team to build for them.
Many factors go into this decision-making process. Each clinical research team must weigh these factors and choose the path that fits their unique situation and supports their research goals.
One of the most significant impacts on this decision is the availability of appropriately skilled resources on the team. A study build typically takes a new iMednet adopter 20-30 hours per week, for eight weeks, depending on the complexity of the study, proficiency in using the software and capacity of the assigned team member(s). Secondary studies will take 10-20 hours per week for five weeks due to replication and copy capabilities within iMednet. Ideally, a research team needs at least one person with expertise in study design who is proficient in using Electronic Data Capture (EDC) software and/or has the capacity to be trained.
Some small and early-stage teams may not have the capacity to support a new study build process. Others may not have the appropriately skilled programming resources on staff. It’s important to consider existing resources when navigating this decision path:
The answers to these questions can help determine whether the team is a candidate to build their study or studies on their own or if they should consider engaging Mednet to build for them.
It is also essential to examine the team’s existing processes and standard operating procedures (SOPs). When documented procedures are already in place, the team can use them to springboard into the study build process. Updating the policies and procedures is significantly less time consuming than creating them from scratch.
- Are there already documented processes that can be updated to reflect Mednet’s best practices?
- Are worksheets and desk instructions available to support the resources participating in the study build process?
- If documented processes do not currently exist, what is the expected effort to create them for the planned clinical trial?
Though resources and processes typically impact every customer’s decision, other complicating factors may also play a role in the decision.
- Are there timing constraints that influence the decision or guide the team toward a specific choice?
The pipeline of planned clinical trials may also affect the decision. Companies with smaller trial pipelines may only use the technology infrequently. They will inevitably require retraining and more time and effort from the team. Suppose the team is facing a robust pipeline of trials. In that case, the team can leverage their learnings and develop and apply best practices in each new trial.
Research teams can also gain value by reusing components of their study builds as templates for new studies. As their experience with iMednet increases, their library of study templates also expands and saves more time and effort in future studies.
Sometimes, additional constraints cloud the answers to these questions and make the path forward unclear. In this case, the experience of the Mednet team can help customers determine the right course of action. The Mednet support team initiates these types of conversations with customers early and often in the engagement process. We encourage customer teams to talk to us about the different design and build scenarios in the context of their research goals.
Our practical experience and understanding of clinical trial processes can be a valuable input into your decision process. We can help you make the right decisions to meet your requirements and successfully build your first study. Contact us today to start the conversation and learn more about the options.