3 must-have pairings with your EDC system

In theory, you can link just about anything to your EDC: from accounting package to your analytics tool and even a label printer. But do you have to want to? Every connection (API) has to be made and set up. This takes time, money and a group of techies who know exactly what they are doing. Do you link the right systems together? Then it delivers a lot of benefits, such as time savings, fewer errors, more ease of use, deeper insights and faster start with the analyses. In our top 3 links, this balance strikes a favorable balance: it is well worth the investment of a link.

Our top three API links for an EDC

1. Transfer data from your EDC to the analysis tool.

Pushing data from the EDC to an analytics tool such as Zoho, R Shiny and Power BI enables faster data analysis and prevents you from having to analyze all the data as one bulk (after the fact). With a link between your EDC system and analysis tool, you can transmit near real-time data. This allows you to start analyzing immediately.

Especially with lab values, this is interesting: for example, you see that 80% of people have a lab value above a certain limit. Is this something you expected, or not at all? And it gets really fun when you have an AI running it. Then you can even predict the expected outcome of the study based on the data brought in so far. So an integration between your EDC and analysis software provides faster insight into the results of your clinical research.

2. Upload data from wearables into your EDC.

How convenient would it be if the data from fitness trackers, medical devices and other wearable devices were automatically uploaded into your EDC system? So that you can see the data not only after the study is completed, but already during the study. Exactly, that would be ideal!

Wearables from the likes of. FitBit, Garmin, Omron and Polar are increasingly being used during clinical research. From your EDC – thanks to a link – you can automatically retrieve patient data from the device and start all your analysis. This allows you to see at an early stage what the patients have done and whether any abnormalities can be seen. This can lead to early interventions.

3. Loading Real World Evidence into your EDC system.

RWE increasingly forms the basis of a clinical trial. But then again, no one wants to manually transfer all that existing data from one system to another. It’s error-prone and a hugely time-consuming job. That’s a shame, because it can be so much faster, easier and more accurate. By linking the original data source to your EDC, you can upload all the data in the correct format and characteristics will show up in your EDC without having to query them all again. For that reason alone, linking the RWE data source and your EDC system is highly recommended.

Challenges in linking an EDC with other clinical research software

An API allows you to link an EDC system with other commonly used software. This allows you to exchange patient data, research results and other relevant information seamlessly between the systems. Unfortunately, implementation is quite challenging because we are dealing with data for clinical research. Fortunately, there is a good solution for every technical bump in the road.

Challenge 1: compatibility between systems

Using middleware (a filter in the API), it is possible to translate data from one data format and/or structure to another. This bridges the differences between your EDC and the other software, allowing them to exchange data automatically anyway.

Solutions:

• Data format conversion.
  Convert from XML to JSON, for example, or from CSV to a database format.
  

• Data field mapping
  Linking various data fields between systems so that
  data are correctly transferred and interpreted between different systems. For example, link the “PatientID” field in an EDC system to “ParticipantID” in a CTMS.
  

• Standardization
  Data are converted into a standard format so that they are consistent and can be easily exchanged and analyzed. For example, consider the notation of a date of birth: DD-MM-YYYY in one system and YYYY-MM-DD in another. Normalization ensures that these dates are converted to a uniform format, say YYYY-MM-DD, before they are added in your EDC.

Challenge 2: synchronizing data

The API ensures that data remains consistent between different systems through synchronization. This means that when changes are made in one system, they are automatically reflected in the other systems. So no matter what system you are working in, you will always see up to date data.

Solutions:

• Real-time synchronization
  Data is immediately updated in all linked systems.

• Batch synchronization
  Data is updated at regular intervals, such as daily or weekly.

Challenge 3: data security

Single Sign-On (SSO) authentication technology allows a person to log in with
a single set of login credentials to access multiple systems such as your analysis tool and the EDC, LIMS and eTMF. This approach is not only more user-friendly, but it also works faster and more efficiently because team members do not have to constantly switch between different systems.

Solution:

• SSO uses advanced security measures
  SSO systems can use advanced security protocols such as Multi-Factor Authentication (MFA), encryption and Single Logout (SLO). This means that when you log out of one system, you are also automatically logged out of all linked systems.
• Management is centrally controlled
  Administrators can centrally set user rights and revoke access as needed. This is especially important for regulatory compliance, audits and security in the event of staff changes.

Conclusion: linking an EDC to other software is smart if it provides sufficient benefit.

An API allows you to securely link an EDC to other software you use during a clinical trial. But always ask yourself the question: what benefits does it give us? For example, saving time, reducing errors, increasing ease of use, improving efficiency, eliminating manual data copy-pasting and shortening study turnaround time. Only when you have the answers to these questions do you know whether the investment will pay off.

For the 3 integrations we mentioned in the blog, the costs and benefits are extremely positive. We’ve seen that time and time again with our clients. So do you want to feed data into your analytics tool or upload data from RWE and wearables into your EDC? Then we say immediately: DO IT!