In the field of clinical trial study services, efficient and reliable data management is a critical success factor. Recognizing this, a leading global provider of clinical trial services sought to overhaul their study data and clinical supplies management systems. They partnered with Traust to create a sophisticated, web-based management application. This application was designed to seamlessly integrate various aspects of clinical trial management and supply chain logistics, reflecting the intricate and high-stakes nature of the pharmaceutical industry.

Robust Data Management for Clinical Trials

Clinical trial study services companies play a pivotal role in the Life Sciences industry. They conduct research studies to evaluate the safety and efficacy of new drugs before they are available for public use. These trials are complex, involving multiple stages, diverse participant groups, and strict regulatory requirements. Efficient data management in such a scenario is crucial. It ensures the integrity and confidentiality of sensitive project data, facilitates smooth coordination across different trial sites, and maintains compliance with stringent regulatory standards. Without a robust data management system, the risk of errors increases, potentially leading to unreliable trial results or regulatory non-compliance.

Built on Oracle APEX

A key aspect of this project was the utilization of the Oracle APEX rapid application development framework. Oracle APEX is renowned for its efficiency and flexibility, making it an ideal choice for creating complex, data-intensive applications like this one. Its low-code approach enabled rapid development and deployment, allowing for a more agile response to changing requirements during the project. Traust’s Oracle APEX development services also ensured that the application was scalable, secure, and easily maintainable, essential for the dynamic environment of clinical trials.

Project Overview

The project’s scope was extensive. Over more than 20 months, we created a custom enterprise application that would not only replace the client’s existing legacy system but also integrate and streamline their data management across various operational facets. The application encompassed several key modules: Materials Management, Clinical Trial Setup and Management, Lab Kits and Visit Management, and Batch Production Management. Each module was designed to handle specific aspects of the clinical trial and supply logistics process, ensuring a comprehensive and unified approach to data management.

  • Materials Management: This module provides a detailed and transparent view of all materials used in clinical trials, including:
    • Detailed definitions of materials, including more than 100 attributes.
    • Master-child hierarchy allowing bulk materials to have unique attributes for different clinical studies.
    • Multi-role and parallel track approvals process.
    • Pre-defined templates for different material types to streamline item creation.
    • Error tracking to help supply managers quickly identify missing data.
  • Clinical Trial Setup and Management: This module provides real-time insights into each study’s status, enabling proactive management and timely decision-making, including:
    • Detailed definitions of each clinical study, including more than 50 attributes.
    • Unique project team roles and responsibilities.
    • Task and milestone tracking for each study, including the ability to import project plans via CSV file.
    • Detailed material planning and approvals management.
    • Logistics management for suppliers, couriers, and supply depots.
    • Site and subject planning per region and country.
  • Lab Kits and Visit Management: This module plays a crucial role in minimizing logistical errors and ensuring the smooth operation of clinical studies, including:
    • Detailed definitions of lab kits, including more than 127 attributes.
    • Dynamic itemized bills of materials (BOMs) based on planned assessments.
    • Automated visit scheduling based on visit type, cycle, and planned assessments.
    • Lab kit and material forecasting and production planning.
    • Quick cloning of lab kits and visits to streamline work processes.
  • Batch Production Management: This module was essential for overseeing the manufacturing process of trial materials, including:
    • Detailed definitions for batch production planning and individual batch runs.
    • Master-child hierarchy for batch management documentation.
    • Supply and production forecasting based on project data.
    • Batch certification and registration documentation to meet compliance with Good Manufacturing Practices (GMP).

“Everyone in the Traust team demonstrated very high levels of expertise and continuous commitment during an admittedly tough project.”

Client’s Project Manager

Project Tech Stack

  • Oracle Enterprise Database
  • Oracle APEX
  • Oracle EBS
  • Integration Platform
  • Document Management Platform

System architecture diagram for the Clinical Trial Supply & Logistics application built on Oracle APEX.

Key Features and Functionality

A Single Source of Truth

The biggest benefit was the consolidation of five different software applications into a single set of views for the operations team. The client keeps data on each project in a variety of systems — a CRM, a document management system, a project management system, a data warehouse, and an ERP. The new application brings all five different discrepant sets of data into a single view.

Now, the different members of the operations team can come to a single point to see the information that they need. Having a source of truth that you can go to and say, this is how that works, that’s a real benefit, because they aren’t trying to constantly compare what the spreadsheet says versus the data in those third party systems. Now, all of that data comes into the new system, and that’s what they manage from.

Closed Loop Data and Document Management

Moreover, the new system a closed loop application. Everything occurs inside the application, including communications and messaging and all of the workflow elements. Previously, the business practice involved passing around a variety of different spreadsheets for each material and project to multiple teams in the business. These spreadsheets would then be presented to the client with multiple changes. Thus, a single project could end up with as many as 20 versions of the same spreadsheet.

The new system automates that data collection and moves all of the spreadsheet information into a true database. Now, the operations team is able to gather that data and the required approvals right from a single application. They can then generate controlled versions of critical reports in non-editable formats for the end customer. That is a significant business — and regulatory — improvement.

Task Management Dashboards

A big part of the goal of the system was to help users understand what work they needed to do at any given moment in order to successfully move projects toward completion. The task management dashboards are a cornerstone for enhancing project management efficiency. Customized to each user’s role, these dashboards provide a clear overview of their current responsibilities across the system. Users can easily track and manage their open project tasks, keeping up with the progress towards completion. The dashboards also highlight pending approvals for clinical study documents and new materials, ensuring that no critical decision is overlooked. An integrated activity feed keeps users informed of all unread notifications, including system-generated updates and user-generated comments. Additionally, the dashboards offer quick access to information on all assigned and favorite projects, streamlining workflow and resource allocation. This personalized approach to task management ensures that every project component is effectively monitored and advanced towards its goal.

System Notifications & User Comments

Oracle APEX includes standard process flow notifications to help keep users informed about data updates. For this project, Traust took in-app notifications to a whole new level. Given the strictures of the client’s highly-regulated environment, the system automatically generates notifications in the background for a wide variety of operations — including every time a user approves a material, rejects a document, or moves a project to a new stage. Users can also manually create comments on each material, document, or project and send them to other named users or every user with a particular role.

To help manage such a large volume of in-app communications, we created a robust notifications dashboard, which included a record of every system-generated notification and user-generated comment each user sent and received throughout the application. From this communications center, users can even reply, edit, or delete their own messages. We also created a persistent toolbar widget that dynamically displays how many notifications are pending for the logged-in user. The widget utilizes on-the-fly JavaScript to update the number of unread notifications as users review them and mark notifications as read or unread.

Complex Roles and Approvals

To help the client meet business, client, and both U.S. and international regulatory reporting requirements, we implemented a multi-role approval process that allowed both parallel and asynchronous approvals with notifications.

Both inventory and study-specific items required at least two separate approvals from users who had specific roles either within the application’s user access management system or within a particular project. The system then alerts relevant users when a material needs their review and approval and provides a designated process for users to either approve or reject those materials to send them back for further review.

Once a material is fully approved, it becomes locked to further changes, in order to ensure regulatory compliance. However, the client also needed a way for select users to reopen approved items for additional editing. Doing so resets the materials to an unapproved state, at which point they need to be resubmitted for approval. The final, implemented solution actually meets standards high enough pass both FDA review and the European drug review board scrutiny.

In addition to approval permissions, each of the required user and project roles had a distinct parent-child hierarchy. Traust built the role management functionality in such a way that it gives the client flexibility in the future to change the existing roles or to expand and add new ones as regulatory and business requirements necessitate.

Data Integration & Conversion

As noted above, the new application integrates data from five separate external systems. As a result, the raw data coming into the new application often does not match from one system to the next. As part of our solution, Traust built a set of administrative functions allowing the client to take any particular data field and set up a manual translation that always translates a given, incorrect value to the desired result when imported.

These administrative screens allow the system admin to control setups and lookups, which will work seamlessly in the new application. This gives the system admin a lot of control to clean up the data, allowing them to always get new data points from the other systems, while ensuring that the data has consistent values and formatting. Moreover the solution is very fast. The client’s dedicated cloud integration application required six hours to process all that data, while Oracle APEX could complete the same processing in less than 10 minutes.

Multi-level Materials Management

Our client needed to be able to purchase clinical trial materials in bulk and then assign them to individual projects. And they needed this new application to support that process seamlessly. They purchase products in bulk, which the system defines as Master Materials. Each master item can then have a unique configuration for each specific customer and/or project. These “study-level” attributes are based on the customer’s unique business requirements, such as changing the material name or other product attributes that will be used further downstream for both reporting and the actual manufacturing processes.

While some companies will break bulk products into smaller groups for resale, doing so requires creating a new, unique item in their ERP system. The Traust solution allows all of the attributes from the Mater Material to flow to the corresponding Study Materials — without affecting other studies that use the same Master Material. And each Study Material will be automatically updated if the Master Material ever changes.

Additional Advanced Features and Functionalities:

  1. Audit History Tracing: A critical component was the full audit history tracing capability. This feature ensured that every action within the application, from data entry to document approval, was logged and traceable. This level of traceability is vital for maintaining transparency and for meeting stringent regulatory audit requirements.
  2. Approvals Management with Electronic Signature Capture: To streamline the approval process and ensure compliance, the application incorporated electronic signature capture. This allowed for faster, more secure approvals while maintaining a digital record that met regulatory standards.
  3. Comprehensive Administration Tools: The application was equipped with extensive administration tools, allowing for seamless management of user roles, data access, and system configurations. This flexibility ensured that the application could adapt to the evolving needs of the clinical trials and the organization.
  4. Integration with Supporting Data Sources: A key success factor was the application’s integration with existing data warehouses, CRM systems, and document repositories. This integration provided a unified view of data, enhancing data accuracy and accessibility, which is crucial for informed decision-making in clinical trial management.

Impact on Client Operations

The deployment of this new clinical trial supply & logistics application marks a significant transformation in the client’s approach to clinical trial management. The consolidation of data and process management into a single, integrated system resulted in numerous operational benefits:

  • Enhanced Efficiency: Streamlined workflows and automated processes significantly reduced manual efforts and the potential for errors.
  • Improved Data Integrity: Unified data sources and stringent audit trails ensured high data accuracy and reliability.
  • Compliance Assurance: The application’s design and functionalities ensured adherence to global regulatory standards, a critical aspect in clinical trials.
  • Scalability and Flexibility: The Oracle APEX framework provided a scalable solution that could adapt to the changing requirements of clinical trials and organizational growth.

The development of this comprehensive application for clinical trial and supply management represents a significant leap in operational efficiency and regulatory compliance for the client. By leveraging the Oracle APEX framework, the project team at Traust has successfully integrated diverse functionalities into a single, user-friendly platform, ensuring robust data management and streamlined processes.

The final application not only enhances the client’s capability to manage global clinical trials effectively but also sets a new standard for technology solutions in the Life Sciences sector. This project underscores the transformative power of well-executed technology strategies in complex, regulation-driven industries.

Want to know how to integrate your critical enterprise applications and gain next-generation functionality for your operations? Contact Traust today!