Identifying your key requirements during the RFI / RFP process for a CTMS - Don’t forget the big picture.

When determining your CTMS requirements you should always start at the strategical level and focus in on your overall eClinical roadmap. I suggest that you do a complete review of the full clinical trial process at the 10,000-foot level and from there begin to fill in the details around your “must have” requirements.

Look at the functions within areas such as:

• program planning

• overall budget management

• 3rd party vendor management

• trial set-up, execution, and close

• shared capabilities including

  • portfolio management

  • training.

These capabilities, as well as others, hold the activities you can use to determine the critical requirements that are aligned with your roadmap.

There are, of course, other key aspects you should consider while developing your eClinical strategy, which in turn will aid in your vendor selection.

• Is your plan to be a fully SaaS based organization?

• How about data accuracy and quality as it progresses throughout the trial lifecycle?

  • If you’ve just begun developing your roadmap, it wouldn’t hurt to look at vendors that are able to cover your key capabilities within a single platform. These vendors can offer a one stop shop, without the need to develop or at least minimize the need for the development of API’s (Application Program Interfaces) to any external applications.

This is a short blog dealing with a long topic; additional aspects such as your eClinical systems and data governance, as well as ensuring your goals are aligned with your organizational strategical goals, are just a couple more of the items that need to be considered.

Want to discuss your goals and how I can assist? Let’s connect.

Next planned blog – Data Migrations Source to Target – Not always a direct hit.