A digital solution for robust clinical trial sample collection

The Challenge

• The sample collection for studies required the shipment of kits to the participants. The client wanted a feature built into the platform’s workflow to allow participants to request and track kit shipments and register them once received.
• Obtain consent for collecting health-related data of patients via the application.
• Convert the participant-provided study data into the Clinical Data Interchange Standards Consortium (CDISC) format to standardize the data for analysis and transmission.
• Adhere to industry regulations and ensure privacy and security controls for safeguarding sensitive patient data.

The Solution

We developed a solution leveraging BTC’s Real World Insights (RWI), a digital platform to collect real world data for clinical trials and research studies, on Google Cloud and its capabilities. The platform included tailor-made features that provided multi-fold benefits for the client’s study initiatives. Our solution incorporated technologies such as GitHub, Secret Manager for generation, rotation, and distribution of secrets, Container Registry for management of container images, and Cloud Build for CI/CD.

Kit shipment workflow support

• The action of placing an order for kits such as blood or saliva sample collection was defined as a ‘special activity’ type in the admin console of the RWI platform. This allowed admins to configure the workflow in the participant mobile application.
• The mobile application itself was also enhanced to support this activity. Users could request and track kit shipments, register the kits once received, and avail instructions to send samples back.
• BTC effectively integrated the RWI platform with the client’s logistics partner to support the end-to-end shipment workflow.

Human API Integration

• The app was integrated with Human API, a third-party integration tool, to collect participant authorization. This consent allowed the client to access participant health-related data and transfer it to their server.
• A pop-up menu was displayed in the mobile application asking for user consent to collect data.
• BTC’s solution followed a handshaking process to communicate with the Human API, and data was pulled over to the Google Cloud Platform when a user provide consent.

CDISC-compatible data format

• Our solution enables admins to convert participant data in JSON structure to CDISC format, including a specific domain and variable name.
• Within the admin console, there are controls for study zones, and each consists of questionnaires for participants. It has 15 CDISC domains defined by the client, including subject elements and lab test results. Associated variables were also created for each domain.
• The solution facilitated CDISC-field mapping, wherein admins can map a CDISC domain and its associated variable to each question in the questionnaire.
• When the participants submitted responses, the answers got tagged to the appropriate CDISC domain and variable names, converting to CDISC format.
• The response server did not store any patient information. BTC ensured privacy and security controls and adhered to industry standards such as FISMA, HIPAA, and 21 CFR Part 11.

Devices:

iOS
Android

Technology:

FDA MyStudies
CDISC
GCP
Human API
Web applications
Mobile applications

The Outcome

• The features built on the RWI platform were reusable across multiple studies and completely configurable using the admin console.
• They were used to ship kits to participants, collect comprehensive health data from providers, and carry out clinical-research-grade reporting by transforming data into a CDISC-compatible format.
• These customized enhancements and their extensive benefits added immense value to the client’s technology and mission.