Scaling up: How work management solutions support clinical trial management software

Consider a global pharmaceutical company launching a complex adaptive trial in oncology. Their clinical trial management software flawlessly tracks patient data, but as the trial expands to more sites, the team drowns in emails and misses deadlines.  

Meanwhile, a midsized contract research organization (CRO) juggles five concurrent trials across different therapeutic areas. Their CTMS efficiently manages individual study data, but as they take on more clinical studies, resource allocation becomes a nightmare, causing delays and budget overruns. In both scenarios, as teams attempt to scale their clinical research operations, they quickly realize the limitations of traditional CTMS.

Enter project management solutions—the missing piece in the clinical trial technology puzzle. By integrating PM tools with existing clinical trial management software, research teams can bridge the gaps in collaboration, resource management, and real-time oversight.

This article explores how project management platforms can complement CTMS, providing the framework needed for research organizations to scale operations smoothly, optimize resource allocation, and keep complex clinical studies on track in today's dynamic research landscape.

What is clinical trial management software (CTMS)?

Clinical trial management software, commonly known as CTMS, is a specialized software system designed to support every stage of clinical trials, from planning to implementation and administration. CTMS serves as a central hub for study management, helping research organizations streamline their workflows and improve operational efficiency.

However, as trials expand and organizations juggle multiple studies, traditional clinical trial management software may struggle with challenges like cross-site collaboration and resource allocation—issues that often require additional solutions to effectively scale clinical research management operations.

Key components of modern CTMS

Modern clinical trial management software typically features a range of essential eClinical tools and functions, working together to offer a complete solution for managing various aspects of clinical trials.

Study startup tools

Study startup tools help streamline the initial phases of a clinical trial. For example, a CTMS might include a regulatory document tracking system that ensures all necessary approvals are obtained before the trial begins. This could involve automated checklists for regulatory requirements, such as IRB approvals or FDA submissions, that help expedite the study startup process while maintaining compliance.

Document management systems

An efficient document management system is helpful for organizing and tracking the vast amount of paperwork associated with clinical studies. For instance, a CTMS might offer an electronic Trial Master File (eTMF) that stores and organizes all essential trial documents. This system could include version control, audit trails, and role-based access controls to ensure proper handling of sensitive clinical trial data.

Electronic data capture (EDC) capabilities

EDC systems allow for accurate data collection directly from research sites. For example, a clinical trial management system with integrated EDC functionality might enable site staff to input patient data directly into electronic case report forms (eCRFs). This real-time data entry can significantly improve data quality and reduce the time required for data cleaning and validation.

Financial management features

CTMS software often includes tools for managing the financial aspects of clinical trials. This could include budgeting tools that help forecast trial costs, track expenses, and manage invoicing. For instance, a CTMS might automate payments to research sites based on completed patient visits, which ensures timely and accurate financial management.

Reporting and dashboards

These features provide real-time insights into trial progress and performance. Clinical trial management software might offer customizable dashboards that display key performance indicators (KPIs) such as patient enrollment rates, data quality metrics, or milestone completion status. These visual tools enable study teams and stakeholders to quickly assess trial progress and make informed decisions.

Comparing clinical trial management software vs clinical trial management systems

While the terms are often used interchangeably, there can be subtle differences between clinical trial management software and a clinical trial management system. The former may refer to standalone applications, while the latter often implies a more integrated, end-to-end enterprise solution. However, both are designed to support clinical trial operations.

Scaling challenges for clinical research management teams

As clinical studies expand, teams face complex challenges. Pharma studies are drowning in emails across multiple sites and mid-sized CROs struggle with resource allocation for simultaneous trials, highlighting the shortcomings of traditional clinical trial management software.

1. Standardizing processes and ensuring compliance across multiple sites and regions

Maintaining consistent procedures, data collection methods, and regulatory compliance across different research sites and regions is essential for ensuring data quality and trial integrity.

Example: A global CRO managing a multi-center trial for a new cancer treatment might struggle to ensure uniform patient assessment protocols across sites in different countries, while also navigating varied regulatory requirements from bodies such as the FDA, EMA, and PMDA.

2. Overcoming fragmented communication and collaboration in multi-site trials

Clear communication and seamless collaboration are essential for successful clinical research, regardless of the locations and departments involved.

Example: A large-scale vaccine trial conducted across multiple countries faces challenges in maintaining clear communication between its on-site teams, remote data analysts, and regulatory affairs specialists, causing poor collaboration and decision-making delays.

3. Optimizing project tracking and resource allocation across multiple trials

Managing interdependent timelines and balancing personnel and budget effectively across multiple clinical trials is a significant challenge, particularly for research teams managing several studies simultaneously.

Example: A biotech company conducting parallel trials for different indications of a novel drug struggles with both progress monitoring and resource allocation. Without an intuitive tracking system, they face delays in submissions to regulatory bodies. Simultaneously, they grapple with optimally distributing their limited pool of clinical research associates across the various studies, leading to overallocation in some trials and resource gaps in others.

6 ways work management platforms improve clinical trial management software

As clinical studies grow in complexity and scale, traditional clinical trial management software struggles to meet the diverse challenges faced by research organizations, from standardizing processes and optimizing resources to supporting seamless communication.

By integrating work management platforms like Asana with CTMS, clinical trials can effectively tackle scaling hurdles. Let's explore how these work management tools improve clinical research management.

1. Provides a unified communication platform

Cloud-based, configurable work management tools can centralize all project-related communications, reduce fragmentation, and facilitate alignment across global research studies. These platforms offer flexible, accessible communication channels that can be tailored to the specific needs of diverse research organizations.

2. Offers powerful project tracking capabilities

These tools provide robust timeline and task management capabilities, enabling efficient tracking of milestones and deadlines. They can also automate routine administrative tasks like scheduling site visit reports, freeing up time for more critical activities like randomization and data management.

3. Enhances data visualization and project planning

Work management platforms offer powerful visualization tools like Gantt charts, Kanban boards, and calendar views. These modules integrate seamlessly with clinical trial data management software, providing clear overviews of project timelines, dependencies, and resource allocation. Gantt charts, in particular, are invaluable for mapping out complex trial processes, identifying potential bottlenecks, and adjusting timelines in real-time.

4. Streamlines resource management across trials

Work management software can help balance personnel and budget across trials, providing tools for capacity planning and workload balancing for scaled operations. Resource allocation is important for optimizing research operations and managing pricing effectively.

5. Allows seamless cross-department collaboration

By breaking down silos between different teams, work management tools enhance coordination among various team members, including physicians, data analysts, and regulatory teams. This leads to more effective clinical data management across departments and supports quality management initiatives.

6. Informs decision-making with real-time insights

Reporting and dashboard features provide access to up-to-date project data, facilitating quicker, data-driven decision-making in large-scale trials. These insights can be particularly valuable in case study analyses of trial performance and improving site management.

Asana: A powerful work management solution for clinical trial management

Combining Asana with clinical trial management software can significantly improve the efficiency of clinical research teams. By addressing key challenges in communication, project tracking, resource management, and collaboration, Asana helps research organizations scale their operations more effectively.

Manage complex dependencies across research studies

• Track key milestones, study attributes, and metrics with custom fields

• Visualize dependencies across teams like clinical research, biostatistics, and regulatory affairs with Gantt view

• Add a single task to multiple projects to keep all teams aware of study progress

Report and share clinical trial progress

• See progress across all in-flight studies with automatic progress roll-ups for goals and reporting dashboards

• Update stakeholders with AI-generated status updates

• Leverage permissions and controls to manage sensitive information and access levels

Streamline documentation and data collection

• Make study documentation easy to reference with Google Workspace and Microsoft 365 integrations

• Use proofing to collaborate on study reports before publishing

Transforming clinical research management with Asana

As the life science industry continues to evolve, the integration of advanced project management platforms with specialized clinical trial management software will be make-or-break in driving excellence in clinical research.

By leveraging these powerful software solutions, clinical research trials can improve their operational efficiency, increase regulatory compliance, and ultimately accelerate the development of life-saving treatments.