Data management
The main return on investment for a CTMS will come from recovering revenue for the clinical trial.
day, can I integrate it with Outlook, can I get this to the lab so they know exactly what tubes to draw?’ All those little day-to-day co-ordination things the study teams have to manage – I think we have got room for growth there.”
The challenge, says Pennington, is that a single element of the CTMS needs to integrate with multiple other systems. “Usually there’s one representation of the protocol calendar in the system – that’s pretty standard in all the systems I’m familiar with,” she says. “But that one calendar has to drive the protocol schedule of the study co-ordinator perspective. It has to drive integration to the medical records system for compliant billing, at least in the States, and then it has to drive sponsor billing activities. So in order to fit the protocol schedule into the system, there are some suboptimal practices that happen, to make it work for one audience or another.”
Main ROI is recovering revenue Pennington’s company, Huron, makes sure that its IRB software integrates with OnCore, the leading CTMS, and with eRegulatory systems: “That’s providing a lot of value, particularly in terms of getting consent forms to the people who need them at the point of consent.” As soon as a new consent form is approved, it can be shared with a staff member in the clinic who can put it in front of the patient for signing.
But, she adds, the main return on investment for a CTMS will come from recovering revenue for the clinical trial: “Part of that is making sure you’re optimising the way you’re doing your financials in your CTMS so that you’re able to recover all those components of the trial that you spend all that time budgeting for.” Thought needs to be given to how those activities are tracked on the study so that the sponsor is billed for them.
Another key feature to look for when purchasing a CTMS, says Pennington, is reporting: “You’re going to want to get data out of these systems for your users. Make sure that reports you’re seeing in demos actually meet the needs the users have. Asking people to spend
Clinical Trials Insight /
www.worldpharmaceuticals.net
a lot of time putting things into the system where they don’t get anything out is a recipe for them not using it.”
A solid migration strategy is essential A CTMS is a “significant investment,” Pennington points out, and before purchasing, organisations should make sure that they have “appropriate staffing, and that they have a solid, realistic timeline and project plan”. They need to approach data migration carefully: “If the data is bad or there aren’t solid migration strategies, you can create a lot of havoc by migrating.”
“We eliminate the need for sites to re-enter data, eliminate the need for sponsors to confirm that the data matches, and we enable sponsors to have immediate access to the data instead of waiting.”
Raymond Nomizu
Even a high-quality CTMS, however, will only demonstrate value if implemented in a way that ensures staff engage with it. “The challenge with any system is getting everyone to use the system in a way that makes the data meaningful at the end of the day,” says Pennington. “There are plenty of people who have made significant investment in CTMS but either because they fail to mandate use within their organisation, or [fail to] put any policies in place to make sure people were using the system, or neglected change management components of their implementation, they end up with a system that doesn’t have reliable data.”
While a CTMS can be a “really good investment for an organisation,” Pennington adds, like all computer systems, it can “help you do dumb things faster. So one piece of CTMS implementation advice is to take the time to think through your workflows before you implement. It’s a really good opportunity to improve what you’re doing and not just automate what you’re doing”. ●
47
everything possible/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53
