With the advent of technology for clinical trials, an old argument plays out each time a new one is introduced. Should stakeholders build their own solution internally or buy an off-the-shelf tool designed for a specific purpose? In the early days of eClinical solutions, pro and con arguments were made for building or buying when solutions such as electronic data capture (EDC) and clinical trial management systems (CTMS), first appeared. But, over time, stakeholders have opted to focus on their core competencies, meaning that any discussion of internal development has shifted to working with providers of these solutions. This is a positive step, especially for study activation, a highly complex part of the study startup (SSU) process that represents 40% of all trial master file (TMF) artifacts in the study lifecycle. Study activation is also an intractable bottleneck, taking an estimated 2½ months. Old arguments for building, such as “our IT department can handle it”, or “we are familiar with the regulatory requirements” are quickly dispelled once stakeholders understand the degree of challenge inherent in trying to build a study activation tool internally.
The focus of this white paper is to describe how Activate, goBalto’s proven purpose-built cloud-based SSU solution, brings a level of efficiency to study activation that is best achieved with the “Buy” option. Activate’s software-as-a-service (SaaS) platform is the last piece of the “clinical stack”, as it integrates data flow from several eClinical solutions, namely EDC, CTMS, and the eTMF, creating an end-to-end continuum and reducing cycle time while providing better oversight and data quality. This functionality is critical to making the kinds of improvements stakeholders and regulatory agencies are seeking to transform clinical trials into a more streamlined process.