The global clinical trial landscape is undergoing a seismic shift, driven by increasing demands and complexities. Navigating this dynamic ecosystem requires innovative, adaptable, and efficient tools. Step into the world of Smooth Drug Development’s (SDD) state-of-the-art Clinical Trial Management System (CTMS) – where innovation and efficiency merge to transform the field. This groundbreaking system is a technological marvel and highlights the company’s commitment to addressing the multifaceted challenges faced by the clinical trial industry.

SDD has ISO 27001:2013 Information security management systems certification. This certification compliments Smooth Drug Development’s current certifications in ISO 9001 “Quality Management Systems” and ISO 22301 “Societal security – Business continuity management systems – Requirements” which prove our company’s continuous improvement of our overall performance and focus on providing customers with products and services of consistent quality and our company’s maintenance of effective business continuity plans, systems and processes.

Reimagining Quality Management

At its core, the Smooth CTMS boasts a modular structure that seamlessly supports both company-level operations and study-level activities. At the forefront of SDD’s CTMS is the Learning/Quality Management System Module. Think of it as a contemporary digital library, meticulously cataloging every crucial document from Standard Operating Procedures to intricate guidelines. This is not just a storage facility; it’s a dynamic tool. Automated workflows, universal accessibility, and heightened security features culminate in a module that doesn’t just meet industry standards but defines them.

Revolutionizing Human Resource Management

Human resources form the backbone of any clinical trial, and managing this asset is crucial. The HR Module within the CTMS heralds a new era of efficiency. Imagine a digital vault where every employee record, document, review, and notification finds its organized space. The HR Module streamlines training creation, assignment, tracking, and reporting, simplifying tasks like matrix development, acknowledgment tracking, and training uploads. It automates training reminders, offers knowledge testing, and facilitates self-training verification through electronic signatures, ensuring seamless training processes. An essential feature is its comprehensive training activity tracking, simplifying oversight and ensuring compliance, leading to cost savings and improved quality management. This is HR management redefined, ensuring compliance without the administrative labyrinth.

Elevating Vendor Collaboration

Every clinical trial’s success hinges on a network of dependable vendors. SDD’s CTMS stands as a sentinel, guarding the integrity of this network. Its dedicated vendor management capability sharpens the vendor selection lens, ensuring collaborations are built on trust, reliability, and excellence. In an industry where the stakes are high, SDD ensures that vendor partnerships are forged with precision.

Mastering Study-Level Operations

A clinical trial is a puzzle, and study-level operations are its intricate pieces. The eDC/eSource/IWRS Module serves as the puzzle master. Configuring multilingual projects, providing diverse data capture avenues, and ensuring impeccable data accuracy are not just features; they are promises etched into the DNA of this module. The module encompasses study planning, database creation and validation, data capturing, query management, data cleaning, medical coding, data export, and more.

The eDC functionality within this module enables organizations to configure projects in multiple languages, supporting diverse international trials seamlessly. It also offers the flexibility to use a combination of electronic Case Report Forms (eCRF) and eSource data collection, allowing clinical sites to choose their preferred data capture methods. This versatility ensures that clinical trials can adapt to the specific needs and preferences of each site.

Moreover, Smooth Drug Development’s eSource function boosts data accuracy with electronic medical history support and secure subject information storage. It excels with features like CRF deadline control, automated data validation, drug stock tracking, and Risk-Based Monitoring (RBM) for selective Source Data Verification (SDV) on lab norm deviations. This efficient approach reduces monitoring tasks while upholding data quality.

Reinventing Patient-Driven Data Collection

In a world driven by data, the voice of the patient cannot be merely an echo. SDD’s ePRO Module ensures it takes center stage. A blend of intuitive design and technological prowess, this module facilitates the capture of patient-reported data with unprecedented ease and accuracy, moving far beyond conventional methodologies.

This innovative module supports a wide range of questionnaires, scales, event recordings, and reminders, providing a user-friendly and patient-centric solution for collecting clinical data. By reducing manual data entry and source data verification, the ePRO Module not only streamlines data collection but also leads to substantial cost savings.

Seamless Document Flow and Integrity

Compliance and readiness are two pillars upon which the edifice of any clinical trial rests. The eTMF/eISF Module is the cornerstone that supports these pillars. Document centralization, real-time insights, and integration capabilities make this module a game-changer in document management. This simplifies management, reduces administrative tasks, and maintains document integrity.

Clinical Monitoring and Management: A Symphony of Efficiency

Clinical monitoring is an orchestra, and the Clinical Monitoring and Project Management Modules are its conductors. They ensure every note, from monitoring visits to milestone tracking, is in harmony, guaranteeing a symphony of efficiency and precision.

This module is designed to manage monitoring visits, monitoring tasks, and site deviations efficiently. It facilitates the tracking of Clinical Research Associates’ (CRAs) visits and workload, allowing for monitoring report review and approval by Line Managers and QA.

Additionally, the Project Management Module within the CTMS serves as a robust tool for managing study contracts, milestone tracking, and expense tracking. It ensures streamlined project management throughout the clinical trial process, enhancing project visibility and control.

Unique Data Tree Structure: Beyond Ordinary Tables

While traditional data management relies heavily on flat tables, SDD’s CTMS brings forth a unique tree-like data structure. Instead of scrolling through endless rows and columns, users can now process large data volumes with ease and precision. The hierarchical structure not only compacts data but also enhances user experience by making data processing more intuitive.

Go-to-Green: Revolutionizing User Navigation with Color

Introducing the unique Go-to-Green color navigation system, SDD has completely redefined user priorities in task management. Depending on data inputs by other users or task deadlines:

• Red indicates urgent tasks, requiring immediate attention.
• Yellow flags regular, planned tasks, holding medium priority.
• Blue signifies tasks awaiting others’ actions, being of lower priority.
• Green celebrates completed tasks.

This ingenious use of color-coded priorities ensures that users, at a single glance, can identify pressing tasks and allocate resources efficiently. As colors aggregate by priority up the tree, users can quickly discern which modules hold the highest priority tasks, addressing them first. If a module’s top layer is green, rest assured, all nested tasks have been accomplished. No more manual hunting or second-guessing task priorities – efficiency is at its best!

eTMF and eISF: Streamlining Document Accessibility

Gone are the days of shipping hard copies and monitoring paper-filled ISFs. SDD’s CTMS eTMF functionality seamlessly integrates the eISF feature, allowing instant online document accessibility to trial sites. Upload a document once to eTMF, and all sites gain immediate access. Simplified, efficient, and remarkably effective.

Multilingual Support in EDC eSource: Breaking the Language Barrier

International trials often grapple with the challenge of a single-language framework, typically English. SDD’s CTMS breaks this barrier with its EDC eSource multilingual support. Investigators across nations can now interact with the system and input medical data in their native tongue. This not only ensures data precision, given that most researchers aren’t translation experts, but also accelerates data entry.

With its unique tree-structured data design, Go-to-Green color navigation, direct eISF integration into eTMF, and multilingual capabilities, Smooth Drug Development’s CTMS stands as a testament to what futuristic clinical trial management looks like. They’re not just evolving with the industry; they’re paving the path.

Our CTMS embodies the future of clinical trial management. From monumental cost savings to unerring data consistency, its benefits are palpable. — Julia Sardaryan, Corporate Development Director

As the horizon of clinical trials expands, SDD is poised to traverse it with vigor. With a resolute vision for global expansion, steadfast commitment to enhancing CTMS functionalities, and a drive to serve a broader clientele including CROs, pharma, and biotech firms, the future of clinical trials looks not just smooth, but transformative.