For many sponsors, study startup is a process everyone strives to make more efficient. Often reliant on manual workflows across site identification, contracting, submissions and beyond, startup activities can be painfully sluggish and prone to unexpected bumps. This further delays timelines, drives up costs and shifts launches.
Fortunately, the long and winding pathway through study startup doesn’t have to be so burdensome. Technologies are increasingly becoming more sophisticated and purpose-driven in automating administrative tasks and providing oversight. This helps sponsors and contract research organizations (CROs) standardize and operationalize their programs for a more seamless startup journey.
This blog explores four modern tech capabilities designed to help decrease cycle times, improve processes and compliance and mitigate site burdens. With more intention around those essential areas—plus investments in the systems powering them—sponsors can realize a more fluid, functional and faster startup workflow.
1. Standardized documentation and exchange
The information exchange requirements of any research program can be enormous. A standardized and repeatable process to generate and exchange documents makes it much easier to systemize programs for faster startup.
You likely already know every trial has a set of essential documents to collect and establish in two consolidated areas: the sponsor’s trial master file (TMF) and the site’s investigator file. With standards underlining the process, including the TMF reference models and ICH-enumerated essential documents, information exchange workflows rely heavily on standardized templates.
Even so, not all “standardizations” are created equally. Many programs use spreadsheets as stand-ins for templates, to their own detriment. Especially for large and complex programs involving multiple sites across multiple countries, standard-order grids don’t account for the many “middle points” along the way.
By contrast, sophisticated technology enables a more dynamic workflow-based exchange system than the flatness of a one-off grid. By including pre-defined templates within an enterprise research collaboration system, it supports a repeatable (and better) process. This saves time for everyone, triggers assignable tasks and milestone statuses, provides a centralized oversight dashboard for all stakeholders to reference, and automates key functions of study startup workflows.
2. Real-time notifications
More isn’t necessarily better. A successful program sends the right updates, to the right people, at the right times.
To make more effective use of real-time notifications, sponsors can benefit from enterprise solutions making these updates more targeted, contextualized and delegable.
- Targeted notifications only get routed to the people who need to see them
- Contextualized notifications allow for more information within every update
- Delegable notifications can be reassigned to someone else
3. Global program visibility and oversight
Giving site and sponsor stakeholders visibility into startup activities can make collaboration more sustainable and meaningful. Creating a shared space through a global dashboard also supports that need. For global visibility to work, though, it requires centralized reporting and visible dashboards of the study activation process for all stakeholders.
A best-in-class dashboard provides optics into where any document is at any point in the process. This would include details on what action items are needed for any given site by providing a command center dashboard. A site and sponsor can visit there first with all questions.
Dashboard essentials include:
- Feasibility status
- Training compliance and completion
- Essential document collection
- Institutional review board (IRB) review status
4. Enterprise integration
Clinical trials involve an ecosystem of many different people exchanging information across many different systems. Integration involves not just the underlying technology, but also the people and processes powering those systems. By fostering more automated connections from point to point, the broader ecosystem becomes better and more supported.
As early as possible in the startup journey, sponsors need to understand which platforms (such as document storage systems) the selected sites, CROs and vendors plan to use throughout the duration of the partnership. Look for opportunities to accommodate and integrate with those systems, and then outline a site-specific plan to gather and exchange information during the trial.
If you’d like support getting started, Advarra offers purpose-built technology designed to help you and your sites achieve a more efficient pathway to study startup: advarra.com/longboat
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