Customizable & Flexible CTMS

 A Flexible CTMS Should Be the Standard

A Clinical Trial Management System (CTMS) forms the backbone of clinical research. However, many organizations face limitations with traditional CTMS solutions due to rigid templates and restricted customization options. This leads to inefficient workflows where researchers must adjust their processes to fit the system, instead of the system adapting to them. At ResearchManager, we believe that’s the wrong way around. That’s why flexibility is the standard in our CTMS platform. In this blog, we explain which features of our CTMS are easily adaptable and how this flexibility optimally supports clinical research.

 1. Roles & Permissions

Traditional CTMS platforms often work with predefined roles and fixed permissions. But this rigid approach doesn’t align with the dynamic reality of clinical research. Take, for example, a study coordinator. In a typical CTMS, the vendor decides what this role can and cannot do. This limits workflow efficiency, especially when that person also handles study registration or selecting participating sites. In many CTMS platforms, adjusting roles and permissions requires expensive custom development, not with ResearchManager.

 ResearchManager Offers Fully Customizable Roles & Permissions

• Complete control over roles and permissions, down to field level

• No vendor-imposed limitations

• Combine predefined roles with individual permissions

• Organizations define which privileges belong to which roles

• Easily scalable for expanding or changing research teams

• No expensive customization required for rights management changes

Full control over access for external parties

• Define precisely what each external party can see or do within the CTMS

• Permissions configurable down to the data field level: edit, view-only, or no access

• Each site only has access to its own study documentation

• Strict protection of sensitive data such as financial records

This level of role and access control is virtually unheard of in the CTMS landscape. While other vendors start talking about custom development costs, ResearchManager offers this flexibility as a standard feature. Making the system adapt to the organization, not the other way around.

 2. Study & Project Types

Clinical trials come in many forms: pharmaceutical research involves phase 1, 2, 3, and 4 studies, while medical device trials include pivotal, pilot, and post-market studies. Yet many traditional CTMS platforms offer just one generic template for all study types. This creates frustration, as a post-market study, for example, requires significantly more documentation, data points, and departmental involvement than a pilot study. With a one-size-fits-all template, researchers are left either ignoring irrelevant fields or missing critical ones, leading to time-consuming workarounds.

ResearchManager Offers Customizable Templates Per Study Type

With ResearchManager, each study type has its own adaptable template. The system automatically adjusts to meet specific research requirements. Relevant validations, fields, and tabs appear based on the selected study type. The CTMS remains tailored, even when multiple studies run concurrently.

• Dynamic adjustment based on study type

• Each type has its own customizable template, at both project and field level

• Validations are automatically adapted to match study-specific rules

• Minimum requirements (e.g., number of participating sites) are actively monitored

The CTMS by ResearchManager eliminates unnecessary complexity, ensuring that researchers have access to precisely the fields relevant to their study.

 3. Process Management

Traditional CTMS platforms often restrict users from creating custom workflows or tailored processes. This hinders efficient study management, forcing organizations to adapt to the system, not the other way around. At ResearchManager, we see this as unnecessary.

 ResearchManager Offers Custom Workflows & Processes

During implementation, we collaborate with research teams to understand their specific requirements. We then configure the CTMS workflows to match their organizational processes exactly.

Smart notifications to prompt timely actions

Our CTMS actively monitors process progress and ensures required tasks are completed on time by notifying responsible team members. Examples include:

• Automatic alerts during process transitions (e.g., ethics committee approvals)

• Milestone reminders and overdue task notifications

• Notifications when tasks or responsibilities are assigned

Main and Subprocesses for Maximum Control

Our CTMS allows organizations to configure major and minor workflows:

• Main processes for essential steps like study registration, reviews, and study activation

• Subprocesses such as amendments can run in parallel

• Full customization based on organizational workflow needs

E-sign Workflow Simplifies Document Approval

Document approval is a well-known bottleneck in clinical trials. ResearchManager streamlines this process with validated e-signature functionality.

• Flexible workflow based on authorization levels

• Signature order customizable by hierarchy or role

• Automatic datetime stamp upon signing

• All signed documents are archived in the CTMS

Unlike rigid CTMS systems that stick to predefined workflows, ResearchManager provides full freedom to configure workflows that reflect organizational needs. While this requires a careful setup, it results in significant time savings and full operational support.

 4. Reporting

Many CTMS systems struggle when it comes to generating (automated) reports. Organizations are often limited to vendor-provided templates, which can’t be adapted to their branding or layout preferences. This is unfortunate, especially when teams already have their own reporting templates. ResearchManager offers a smarter approach.

ResearchManager Generates Reports in Your Branding

• Create reports using your organization’s own templates and visual identity

• Or let us adapt our templates to your branding

• Automatic population of the correct data in the right fields

• One-click report generation ready for immediate use

Templates Tailored to Stakeholder Needs

Provide the right information for the right audience with stakeholder-specific templates.

• Automatically generate reports based on stakeholder type

• Save time on recurring or scheduled reports

A flexible CTMS with this kind of reporting capability saves research teams valuable time, leading to more efficient workflows and enabling professional, consistent communication across all stakeholders.

 Conclusion: A Flexible CTMS Is Not a Luxury, It’s a Necessity

The complexity of clinical research demands a CTMS that adapts to your organization, not the other way around. By putting flexibility at the core, ResearchManager empowers teams to structure processes exactly as needed, regardless of study type or organizational scale. This adaptability leads to more efficient workflows, better collaboration among stakeholders, and ultimately shorter study timelines. A flexible CTMS is the foundation for successful clinical research in today’s increasingly complex environment.

Struggling with Your Current CTMS?

Tell us about the limitations you’re currently facing. We’ll show you how ResearchManager can do it better.