Series: Selecting an EDC Part II
posted: October 11, 2016
by: Brian Olender
Selecting an Electronic Data Capture (EDC) vendor and system is a daunting task. This is true for sponsors choosing systems in a study-by-study model where there is a desire to optimize the solution for each study. There are a number of important considerations to take into account when selecting an EDC solution for your clinical trial.
Therapeutic Area and Study Complexity
Certain therapeutic areas and studies require more complex study design. Some examples include oncology trials, medical device trials, or studies where significant data points need to be checked across forms or across visits. This can require significant complexity in data validation, derivation, and edit check programming. If the study has a complex therapeutic area, protocol, or associated data validations, EDC system capability in this area needs to be considered in detail. Additionally, if this design is expected, it may be required to contract a specialized programming resource skilled in languages such as MS SQL, C-Sharp (C#), and XML to assist with more advanced programming depending on the system and how it supports more complex custom data validation programming.
Will it be necessary to integrate data from any other systems into EDC or to feed data from EDC into other systems or tools, such as randomization systems (IVR/IWR), Clinical Trial Management Systems (CTMS), Investigator Payment solutions, lab data, etc.? If so, it is important to understand if and how the EDC system supports system integrations, including data import/export and available data formats. System integrations can add significant complexity to study design and startup, and so this should be considered as early as possible in the selection process, including ensuring that knowledgeable technical resources are available both during EDC vendor evaluation as well as during requirements gathering, study design, and system configuration and integration. Additionally, some level of validation is likely to be required to support system integration, so the EDC vendors should be queried as to whether they offer out-of-the-box validated solutions and to also include resources with systems validation and compliance experience in the discussions.
Central vs. Local Labs
Another consideration is whether the study will utilize central labs, local labs, or a combination of both. If local labs will be in use on the study, it is important to consider if the EDC solution supports local lab administration. As part of this evaluation, there should be discussions with the vendor regarding how the administration is performed including the use of the lab administration module, how difficult it is to change lab normal ranges, what skill set is required of a potential lab administrator and if any system downtime is required to perform and deploy administrative changes for labs. Additionally, if central labs are used and there is a requirement to integrate central lab data into EDC, the data and system integration considerations mentioned above should be taken into account.
Study phase can also have impact on EDC system selection. Phase I studies can often have simpler design that may not require the full functionality of a robust EDC system. Choosing a “lighter” EDC solution may allow sponsors to save money on already minimal Phase I budgets. Phase IV studies may also have particular challenges to be addressed. This can include simpler design or geographically specific concerns such as for Japanese Post-marketing and Surveillance (J-PMS) studies that may require unique study or query workflow. Depending on the geography, it may be advisable to use an EDC solution specific to Phase IV studies in that locale. Late Phase III and pivotal studies may require additional complexities in dosing, concomitant medications, and labs that may result in more complex design as discussed above. It is important to consider all implications of study phase as EDC systems are evaluated and selected.
As can been seen, there are many factors to consider when selecting an EDC vendor and system. This is by no means a comprehensive list, but it should provide at least a high-level overview of the many considerations in choosing an EDC solution. This is a very important decision for sponsors as choosing and implementing an EDC solution can have a direct impact on the success, workload, costs and quality of producing your most important intellectual property: Clinical trial data that directly supports your product’s submission and approval.
When it comes time to select and implement EDC for your clinical trial, let Emanate Life Sciences guide you in this process. Our deep expertise and knowledge of EDC vendor selection and implementation will help remove the guesswork from the process and help put you on the path to quality and success in your clinical trial.