Anyone involved in the clinical space, especially those in small to midsized pharma, bio and medical device companies, knows internal resources are constantly being stretched. Everyone is being asked to fill multiple roles while still trying to reduce timelines and make study development efforts more efficient. And of course, make sure you do not compromise on features, functionality, or quality. George Slavish, VP of Implementation Services for BioClinica – a leading provider of eClinical solutions, often has clients come to him saying they want to work with a partner that can help them reduce the time it takes to start a clinical trial.
"In working with these sponsors, I realized the biggest obstacles all seemed to revolve around proper communication with customers and the old way of doing things," says Slavish. "Communication seems like a simple thing, but it still has to be performed the right way to be effective. It also seems the old way of collaboration is giving way to more productive best practices. In the old model, a sponsor would go to an eClinical solution provider with their specifications to build the study in an Electronic Data Capture (EDC) solution. This would then be given back to the sponsor for review. The sponsor would then provide a list all of the things that were wrong, misunderstood, or that they weren't expecting. Basically, there was a lot of back and forth and, as a result, a lot of wasted time. That entire process leads to longer development times and a lot of frustration on both sides."
George Slavish, VP of Implementation Services, BioClinica
Slavish recently had a customer come to him that was behind on their deadline and needed to get the project done in less than three weeks. He knew the deadline could be met, but not by following the same old plan. Using a different approach, he made a plan, walked them through it, scheduled multiple touchpoints along the way (from day one all the way through to completion), and ensured any assumptions on either side that could derail the study were eliminated.
The study was a success and the client did meet their deadline. Many best practices were learned along the way, and Slavish was willing to share them with Clinical Leader.
1. Get commitment on both sides. For a study to be a success, most sponsors know they need to get commitment on the part of their EDC provider. But just as important, Slavish notes there has to be commitment on the part of the sponsor as well. If the EDC provider produces a schedule of critical touchpoints, there must be commitment from everyone involved with the project. If not, important milestones will be missed, and deadlines will be in jeopardy. Both sides need to work hard, and be dedicated to make the project a success.
2. Avoid making assumptions. Assumptions are one of the most important roadblocks that must be eliminated. Everyone is trying to use established standards these days, and that effort has led to the creation of a common language that everyone understands. Still, there are implementation details that are not defined explicitly in all the standards. As a result, everyone might have a different take on them, and every service provider might have a different way of implementing them. For example, the EDC programmer might envision how a study should be designed from a given protocol, while the client had something entirely different in mind. Or a client might expect data for a certain field to be collected, while the programmer felt the data was unnecessary. Even when the client provides specifications, there is still some interpretation that must be performed.
"To avoid confusion and misinterpretation, which can lead to costly delays, it is better to eliminate any assumptions right up front," says Slavish. "Assumptions are the killer of any study. If we can get over those, get everyone on the same page, and understand what they truly want from a study, we can eliminate a lot of wasted time and effort."
3. Understand your options. Unfortunately, there are times when the client thinks they know what they want, but don't understand all of the available options. One of the important touchpoints that should be a part of the timeline is the opportunity for the EDC experts to demonstrate different options. Without options, there is a better chance the client will not get what they want, which will again result in costly delays. Presenting options after a study has been developed is too late. These options must be presented and understood right up front.
4. Understand the cost/benefit analysis. Slavish has seen instances of sponsors requesting extra complexity be added to a study simply because they felt it was necessary. Oftentimes, that extra complexity (for example additional but unnecessary edit checks) is not necessary. "We see it as our duty to help clients look at the situation from a value-add perspective," he says. "Personally, I like to challenge them. If they request additional functionality or complexity, I will ask them what extra value will be added by including that functionality. If they can't answer the question, it is probably not necessary. Adding in extra and unnecessary burdens, simply because you believe you need them, will only lengthen the timelines while adding no additional value. A little extra analysis up front can help to eliminate that."
Since added complexity will also lead to added costs, eliminating unnecessary steps can also help reduce the expense of trials.
5. Hold meetings face-to-face or via web access. Phone conversations can be effective in certain situations for communicating details or resolving issues. However, when reviewing builds or discussing study options is on the agenda, they are simply not adequate. These meetings should be prearranged, put on calendars, and be conducted in person or via web access.
These are opportunities for the sponsor to ask questions, get additional information, get clarification on topics relating to specs and protocol, and be presented with alternative options. Therefore, both sides need to see what the other is doing.
"I advise clients to go to the service provider or have them come to you," says Slavish. "It is impossible to properly discuss modifications over the phone. This will certainly add additional expense to a study, which can be a concern to some clients, but it does create a more effective and collaborative experience. By the time these meetings roll around, there should only be minor modifications, and we typically walk out of those meetings with a production ready system."
6. Let the EDC experts review your specifications and make recommendations. This is especially true for smaller and mid-sized companies that might be combining specifications to meet the needs of a protocol. When doing this, it is very easy to get in over your head. It is always a good idea to have a second set of eyes review what you are doing. The review can also uncover any gaps you may have missed or don't properly understand. The review is a good opportunity to discover complexities with no value add, and is a good time for the EDC programmers to present you with additional options.
7. Finally, avoid the temptation to rely solely on technology, since that alone is not enough to ensure the success of your study. Every eClinical Solution provider has technology which they feel is the best, but it is just a tool. Don't waste a lot of time trying to figure out who has the better technology. It's important, but you have to consider the process and service behind it and look to develop a collaborative partnership. Ultimately, that is what will determine whether or not your study is a success.
"We certainly have customers who don't want to work in this fashion, or don't want to make this type of commitment," adds Slavish. "We still support them, but are trying to move in this direction of greater collaboration because we have seen the benefits it can bring. We are now working with a number of customers in this manner and it is paying dividends by giving the customer a better experience."