The Best EDC System for Clinical Trials

Clinical trial sponsors should consider a number of factors before selecting an EDC solution for their clinical study.

Below we analyze the main factors to take into account to make a good decision.

1. Compliance with quality and security requirements, and regulatory standards

First —and certainly fundamental— clinical trial sponsors must ensure that the EDC systems they are evaluating meet all quality, security, and regulatory standards.

From a quality and security perspective, EDC platforms must be validated systems that guarantee the traceability and integrity of the data collected.

For example, all EDC applications must have an access control mechanism, which allows monitoring which users are accessing the platform at all times. This system must record connections and disconnections including detailed information on dates and times.

At the same time, EDC solutions have to integrate an audit trail module capable of tracking user activity in the system. This audit trail module records what data has been entered or modified by users at all times, generating an auditable log in case of inspection.

Conducting clinical trials is a highly regulated activity, and regulatory agencies —such as the Food and Drug Administration (FDA) of the United States— have developed and published regulations that must be met by computer systems used in clinical research. More specifically, EDC systems must be implemented in compliance with the requirements of Title 21 CFR Part 11.

2. Level of technological integration with other applications and systems

Another important aspect that clinical trial sponsors should keep in mind is the level of integration they will need with other applications and systems. That is, will it be necessary to use other software systems in conjunction with the EDC application?

Today, various software applications have been developed that work together with EDC systems. Some examples are randomization and medication management systems (Interactive Web Response Systems – IWRS, Randomization and Trial Supply Management system – RTSM) or applications —usually mobile— through which patients provide information by themselves (electronic Patient Reported Outcomes – ePRO).

In addition, many EDC tools are capable of receiving external data from other sources (e.g. laboratory data import), which requires special functions.

Therefore, when choosing an EDC system, it is very important to know whether you will need other systems integrated with the EDC tool or not. Some sponsors will have enough with the EDC software alone, but others may have a need to integrate other tools.

Sponsors must ask themselves: if I need more than one application, can I get all the applications using a single provider? The principle should always be to unify in the same provider, as this facilitates integration and reduces the efforts of having to use different providers.

3. Level of customization for specific needs

Many of the EDC tools available on the market are products that do not allow tailor-made developments, that is, they are pre-designed applications to collect information and function in a certain way.

For the purposes of clinical trials these tools are usually sufficient because data is collected in a similar manner in all clinical studies.

However, sometimes clinical trial sponsors may have specific workflow needs and may require custom development for certain functions or integrations.

Trial sponsors therefore need to check whether the system they are considering will meet all of their particular needs, or whether customizations will need to be made at some point.

4. Who will develop the EDC system specifications?

The implementation of an EDC system requires specifications detailing what data will be collected and in what way.

Some documents related to the implementation of an EDC system are the annotated CRF, the data management plan, and the data validation plan. Who will prepare this documentation? Does the sponsor only need the EDC system as such or will he/she also need data managers who develop all the related documentation?

Sponsors should know if the EDC provider only supplies the EDC application or if it also offers additional documentation services.

5. Who will implement the EDC system?

Another aspect to consider is who is going to implement (build) the EDC system (according to the data forms and fields needed).

Many EDC products allow people with sufficient technical knowledge to be able to build the system. If a clinical trial sponsor does not have this staff, then they will need the EDC implementation service.

Several EDC system manufacturers also offer the implementation service, or at least are able to recommend a data management company that can take on this task.

6. Additional services for data cleaning and statistical programming / analysis

After the specification and construction stages of the EDC system comes the need to clean, process and analyze the clinical data entered into the platform.

Cleaning the data of a clinical trial is vital because it ensures that the final data being analyzed is correct. When hospitals enter data in EDC forms, errors and discrepancies are usually detected and they must be solved through queries. This data review and cleaning effort is performed by data managers, statistical programmers, and clinical operations personnel, typically provided by clinical research organizations (CROs).

Another task of great importance is statistical programming. Statistical programmers work with the collected data to generate tables, figures, and listings, which will be used for scientific publications.

In short, conducting a clinical trial, at the data management level, not only requires the provision of an EDC system and that is it. There are multiple services and tasks required to properly collect, clean, and analyze clinical information. The clinical trial sponsor must ensure that these resources are available.

7. Available budget

Finally, like everything in life, we must review what we can do with the money we have. The budget of the clinical study is a key factor in knowing what technological solution can be purchased.

In the clinical research market there are EDC tools of different prices. As a general estimate, an EDC system for a 12-month phase 1 clinical trial in oncology could cost approximately US$ 30,000 to 140,000, depending on the system and services needed. With this we can see that the price range is quite wide.

The budget for a small, non-profit academic clinical trial will not be the same as a global randomized clinical trial, involving multiple countries and hundreds of patients.

What budget does the sponsor have for the EDC tool? The funds available for this purpose must be clear.