trends & perspectives in clinical research

goBalto Chromosome

A Build vs. Buy Look at Study Activation

by Jae Chung

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?

A Build vs. Buy Look at Study Activation

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 2.5 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.

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.

Moreover, Activate can be deployed within weeks to a live study, allowing stakeholders to reap the benefits of this approach without delay. By comparison, attempting to build is likely to take several years, followed by months, or even years, of implementation and fine tuning. During that time, a SaaS service would have been updated, rendering the "build" option even farther behind.

In determining whether to build or buy, stakeholders might consider making the decision based on several key factors:

  • Complexities of SSU
  • Knowledge of requirements
  • Cost

For better study activation, each of these factors poses a tough challenge, but combined, they are daunting. They render "buy" the most sensible, timely, and ultimately, a no-risk option by eliminating fear, uncertainty, and doubt.

Download our white paper A Build vs. Buy Look at Study Activation: How Activate, a SaaS-based Platform, Manages the Complexities of Study Activation for a deep dive into key factors that need to be considered when making this determination.

If there is a commitment to improving study activation, it behooves stakeholders to evaluate the pros and cons of building a tool internally versus selecting a purpose-built cloud-based tool, such as Activate, which is proven to shorten cycle-time. Because of the level of complication inherent in building internally, and the need for a detailed understanding of technological requirements, moving toward a no-risk buy option makes the most sense. With this choice, users have ready access to a complete solution and only pay for what they use. This methodology is the last piece of the clinical stack, linking data across the continuum, a much needed functionality for stakeholders seeking to disrupt the long-standing challenges of study activation and replace it with a SaaS-based solution built to speed clinical trial operations.

Jae Chung
President and Founder
goBalto, Inc
Jae Chung is the president and founding visionary of goBalto. A startup evangelist, Chung wants to change the way pharma and CRO companies initiate clinical trials. goBalto's purpose-built study startup SaaS solution allows stakeholders to better adhere to established timelines and budgets, with customers reporting reduction in cycle times by 30-plus percentage, thereby getting medicines to those in need faster.

Chung works with Rock Health to mentor healthcare technology startups, and previously co-founded Celltrion (068270:KOSDAQ), a leading biopharmaceutical manufacturing company. Prior to Celltrion, he worked as a strategy consultant with McKinsey & Company.

In 2013 Jae was recognized as a FierceBiotechIT Top-10 Techie list and in 2010 was awarded the Bio-IT World Judges Prize for Technology Innovation. Jae has experience in drug development, commercialization, and business development. He has an MBA from New York University and holds a CPA.

Recent Posts