Optimizing the Study Build Process

As veterans of several EDC systems including Medidata Rave, Andrew, Steve and I are sometimes asked if we plan to build a new EDC system?

We don't. Competition is good but whether you are a fan of Medidata Rave (as we are), Oracle Inform or any one of the many available EDC systems, a new EDC system is not likely to improve your study build process.

So No, we don't plan to write another EDC system. Instead our focus is on taking the Medidata Rave Study Builder experience from good to Awesome (and we're all British here, we don't say "Awesome" lightly).

Tools and Process

The Tufts Center for the Study of Drug Development recently reported that the time to complete study build is a major factor in the delay of study starts. A new EDC system won't improve the efficiency of the process much because it is just one tool of many that are required to complete the study build process.

To use an analogy, think of your kitchen at home. Will buying a new stove make the process of preparing meals more efficient? It might but unless the stove is really broken it is more likely that the gain will only be marginal.

Much more important to efficiency is the layout of your kitchen. Unless you live in a small space the chances are your kitchen is laid-out in a traditional triangle with the refrigerator, sink/worktop and stove all situated at the corners.

Kitchen layout (Credit Wikipedia: https://en.wikipedia.org/wiki/Kitchen_work_triangle)

The kitchen is a familiar example of a work cell, an arrangement of tools that is optimized to make a process more efficient. The arrangement means that ingredients, stove, water etc are all in close proximity so that travel time and the time to switch between tasks is minimized.

So is your EDC system really broken or is it just that the overall process isn't designed to get the maximum efficiency from it?

Work cell software for Software Development

In recent years online tools that act as work cells have appeared for Software Developers. You may have heard of online tools such as Bitbucket, GitHub and GitLab but if you haven't, these are services which bring together source code management, code review, issue tracking, documentation, automated build and many other tools in a single environment. These tools have been hugely beneficial to us at TrialGrid, streamlining our process and allowing us focus on writing more than 45,000 lines of code, 1,800 unit tests and hundreds of requirements tests in a little over 15 months.

Our goal is to bring those same benefits to Medidata Rave study build teams.

TrialGrid : A software work cell for your Rave Study Builds

If you have a team building Medidata Rave studies, then alongside Rave itself you will have tools and processes for:

  • Managing Specifications
  • Managing a team roster of responsibilities for a study
  • Shared file system or cloud storage for study documents such as Protocol versions
  • Issues, list of tasks left to do or of findings from User Acceptace Testing
  • Tracking the tested status of Edit Checks and Custom Functions
  • Tools (or people) to perform best practice and quality checks on objects built for the study
  • Tracking standards compliance of the build along with reasons for deviation
  • Some system to gather metrics together in order to report on the whole process

You might have best of breed solutions for many of these: Jira for Issue Tracking, Microsoft Sharepoint for storing documents and collaboration, SAS Programs written specially to perform quality checks, Microsoft Project for your team management and a custom Specifications Management tool (even if this is a spreadsheet) but the constant switching between tools slows down the overall effort and improving any one of them doesn't do much to optimize the process as a whole.

TrialGrid brings together:

  • Enhanced study build tools for Edit Checks, Forms, Deviations, Matrices and more
  • Standards Compliance and Global Library workflow - with deviation explanations and reports
  • Automated study build best practice checking tools - with instant audit-trailed fixes
  • Issue management with task assignment and links to study build objects
  • Project File storage
  • Project Wiki for team collaboration
  • Study team assignments
  • Audit trail of all actions, including study build activities

Into a single system so that the team doesn't have to switch between tools. Issues can be linked directly to the objects that implement that spec (e.g. direct to an Edit Check definition) and the history of that Edit Check can be reviewed (where did it come from? who created/edited it, when) along with its compliance to a global standard (does it deviate? How? Has this been explained? Has the deviation been accepted? Rejected?) Team members can run best practice checks on the study at any time and immediately fix or explain any findings. All the tools are linked, together in once place.

Specifications management is an area we are particularly interested in. Specifications are a type of Issue and can be used to manage Specifications but we have bigger plans.

We still have work to do but if you are frustrated with the pace of your EDC study builds get in touch to see how TrialGrid can help.