Intimidated by the daunting task of choosing an EDC? Not sure what factors to consider? Find out about how to select the best EDC for your project with PharPoint Principal Data Manager Jenifer Ehlers.
Choosing an EDC Transcript“Whether choosing your first electronic data capture system, also known as EDC, or adding a new EDC platform to your arsenal, deciding between the numerous providers can be overwhelming.
Many EDC providers can meet the basic needs for a study (regulatory compliance, the ability to enter data and make changes to it and the ability to export data from the system), but from there it’s like comparing apples to apples. Will a Red Delicious meet your needs or is a Honeycrisp a better fit? Just because a system has more to offer, doesn’t make it the best system for your company.
To narrow your choices, you will want to consider costs, timelines, available features of each system, and the resources needed to support the study design with the EDC system, i.e.:
• Do you have programming support for the system internally?
• Will you need to outsource the service or can the EDC provider develop the study database for you?
Breaking down the selection and implementation process into four stages will help your team choose the best system for your company’s needs without seeming like an impossible task.
Stage 1: Identify the EDC Selection/Implementation Team and Set Expectations
An ideal selection team will incorporate a mix of end users, such as:
• Data managers
• Clinical support staff
• Project managers
• Or representatives from QA
Your selection team often evolves throughout the selection process and may contract and expand based on the providers being considered and the stage of the selection process. Many team members will also be a part of the implementation process. The selection team should be large enough so that stakeholders have a voice in choosing the platform, but small enough for you to achieve a consensus on decisions without slowing down.
Once a selection team is in place, it’s time to set expectations which includes meeting frequency, responsibilities, communication and creating a realistic timeline for selecting the EDC provider. Consider business needs such as upcoming studies, corporate goals and team schedules, training and the implementation process when creating a timeline.
Stage 2: Define the User Requirements
A variety of functional areas will rely on different aspects of an EDC platform, which is why you want a selection team to be diverse; to receive perspective into a platform’s requirements. Each selection team member should be tasked with coming up with a list of needs and wants, as well as any items they would not like to have in a system.
When developing the list of user requirements consider the company’s typical study design:
• Phase, SAD, MAD, DDI, Cohorts etc.
• Number of subjects
• Number of sites and their geographical locations
• The expected number of case report forms (CRFs)
• Duration and other specifics such as standard reports
• The need for safety alerts
• Vendor data uploads
• Helpdesk support
• Data entry screen design flexibility
• Bulk approval (PI and monitoring sign-off)
• Query management
• Medical term coding functionality
Think about the type of pricing structure that will work best for the company (volume discounts, annual licensing fees, pay by study, etc.). Who will maintain or host the application on a server? Consider other systems used for study management and conduction by your company such as a clinical trial management system (CTMS) and an interactive response system used for randomization. Do you want an EDC system that is compatible with these systems or are you looking to replace the multiple vendors with an all-in-one solution?
These specifications will drive costs as well as guide your thinking about what features you will need from a provider.
Stage 3: EDC Provider Meetings and Demos
Based on the agreed upon requirements, vendors should be invited to meet with the team and demo the applications. If you have requirements that are show-stoppers (such as hosting, pricing, standard reports) it may be a good idea to provide the EDC provider with a quick survey prior to meeting. This way, if the provider cannot meet the non-negotiable requirements you can remove them from consideration and focus on vendors that do.
When meeting with the EDC providers, don’t be afraid to ask questions based on your experience with other systems, your pain points and based on feedback you have received from site users and partner vendors. At the end of the day, this is an investment and commitment by your company. You want to ensure that you have all the facts to make an informed decision.
Get a feel for their customer service:
• Are they responsive and flexible enough to meet your company’s needs?
• Will you have a dedicated representative you can reach if an issue needs to be escalated?
• Will they allow you to test drive the system?
• If you have a feature request, are they at least receptive to the suggestion?
During the demos, the EDC providers are putting their best foot forward, but you can still gain a lot of insight into their post-sales experience.
Stage 4: EDC Provider Selection
You have narrowed down the list and are ready to decide. If you haven’t done so already, now is the time to engage QA to audit the provider and ensure that they can be considered as a qualified provider for your company. You don’t want to sign the EDC provider’s contract only to realize that they do not have validation documentation to support the functionality and regulatory compliance touted during the demo.
If you are down to two companies and find it hard to decide between the two, take another look at the list of nice to haves/wants. Are there features one provider offers that you may need in the future and the other provider does not? Think about the provider’s company culture. Is one EDC provider more in-line with that of your own company?
Here at PharPoint we have navigated these waters before and have chosen two different EDC providers, Medrio and Medidata, as our primary vendors. However, our teams are experienced in many different systems and can easily work with any EDC provider a client chooses. We can also help you select an EDC provider that will work best for your company.”