The following post is written by our partner Nektarios Sartzetakis, CEO of NemoLogix.
When developing Web Applications for large-scale databases and Big Data, there are multiple challenges that must be taken into consideration. It’s not just about the app. More critical is the data and user interaction with the app.
We’d like to share our experience during a recent e-CRF project. This project is an excellent example of the complexities associated with web and mobile application development.
A CUSTOMIZED BACKEND FOR EACH TRIAL
A CRF (Case Report Form) is a paper or electronic data entry form utilized in clinical trials. It is used by stakeholders involved in clinical trials, such as hospitals, to collect data on each trial participant. All of the collected data on each individual participant in the clinical trial, including information on adverse events, are contained in the Case Report Form. More and more companies are moving to a digital CRF due to the benefits of electronic tracking versus paper-based forms. However, this move requires diligent planning and execution to ensure participant safety and privacy.
Because of the variations from one clinical trial to the next, each requires some level of custom development. For example, a Case Report Form needs to be developed specifically for each clinical trial so that all of the data specific to that research project is captured. The organization running the trial is responsible for designing a Case Report Form in line with the protocol of the trial. They must also monitor and audit the collected data to ensure it is complete and accurate.
For a successful e-CRF project, custom backend software must be designed that will host the data and perform the automated procedures to streamline data processing at the conclusion of each stage of the clinical study.
ABOUT BIG DATA IN CLINICAL TRIALS
In the past, clinical trials have utilized only a minimal amount of structured, clinically-sourced data, which was relatively easy to organize and mine. Today’s databases and tools allow us to not only store but to quickly analyze terabytes of unstructured data from a variety of data sources. With the ability to scale technology to collect this unstructured, real-world data and organize it into comparable formats, analyze it, and visualize the results, we can help clinical trial researchers easily uncover evidence for known relational trial factors and explore the data for unexpected patterns. These unexpected patterns can potentially lead the researcher to a new hypothesis that can be validated by the trial data.
When designing the backend of such a complex system, we focus on creating the data structures in order for the following tasks to be performed in the most optimal way:
- Easy and uninterrupted data collection from all sources
- Fast data storage and validation of data
- Real-time analysis of the data
- Intuitive user interface
At NemoLogix, our focus is on making all processes run smoothly. For the e-CRF project, this means designing the application so that medical personnel can focus on rapidly collecting data and analyzing the results.
SECURITY & PRIVACY
Participants in any clinical trial have an expectation of regulatory protection of their privacy. Beyond a clinical trial application, any technology needs to be developed with a focus on big data security and privacy, and include the following capabilities.
The individually identifiable data elements, such as name, telephone number, email addresses, etc., when combined with health information about the participant, make such information Protected Health Information (PHI). For this project, our design ensured that this kind of information is NOT disclosed in the CRFs. Instead, to ensure anonymity, each patient is given a unique identifier.
Data Encryption is vital with any application that stores and manipulates data. This becomes even more critical when medical histories are part of the data processing equation.
This project included the following encryption strategies as part of the e-CRF platform:
SSL Transport Encryption
SSL (Secure Socket Layer) is a common encryption protocol used to encrypt data between network endpoints.
Transparent Data Encryption (TDE)
While SSL encrypts data in motion on the network, TDE encrypts data at rest. This additional encryption follows copies of the data to ensure no access, even to copies, without the proper keys.
Like TDE, this encryption of data ensures database backups cannot be accessed without proper keys. This is a critical encryption technique as backups can move through many hands.
SIZING, HOSTING OF THE APP, PERFORMANCE
This e-CRF project required hosting in a private cloud installation with a starting point of 500TB of storage that continues to support all of the data that the current trial is collecting.
The Web Application was designed to support multiple trials running simultaneously with thousands of trial sites.
Our design met the following criteria:
- Unlimited trials with thousands of trial sites each
- 10,000 concurrent users on data entry forms
- Unlimited concurrent users on data and analysis viewing
- To meet bandwidth needs, cloud services were used to ensure that all reports and data were delivered rapidly and without bandwidth limitation of the private cloud.
Many companies think that a web project is simply about developing an app, but with complex projects like this, the majority of work is on the backend. It takes development expertise to customize the forms, collect the data, and adhere to best practices in Big Data Storage and processing while always adhering to strict Privacy and Security of the Data, a critical aspect of any clinical trial case. Beyond Big Data, a complex project like this must support the high volume of users, data collection, and throughput.
To learn more about this and other NemoLogix projects, visit us at www.nemologix.com.