Better Trials, Better Outcomes: Why Every Biopharma Needs a CTMS

Streamlining In-House Trial Management
With a Modern CTMS

A CTMS is considered the hub of clinical operations. Yet some sponsors still rely on manual tools like redundant spreadsheets, local drives, SharePoint, and data lakes that aren’t built to handle the complexity, data volume, and diverse regulations of modern clinical trials. 

These tedious processes slow clinical trials down, jeopardizing your company’s growth. Implementing a modern CTMS that is optimized for your business operations is key to improving trial speed, timeliness, costs, and accuracy.

Challenges of managing clinical trials in-house

Having an in-house clinical operations team can help you maintain greater control over your trial design, execution, and data collection. But it can also come with challenges if you don’t have a CTMS — especially as your company grows and you manage more trials simultaneously.

• Disconnected systems and spreadsheets: Data silos and redundant processes reduce productivity and prevent collaboration.
• Difficulty configuring, customizing, and using manual tools: Rigid, inflexible legacy spreadsheets and systems struggle to support complex trials. They can also be challenging to integrate and costly to maintain.
• High operational costs: Inefficient monitoring and cross-functional processes add costs and slow trials.
• Limited visibility: Lack of real-time visibility to performance across the portfolio prevents proactive study and vendor management.

Benefits of having a CTMS for in-house clinical trials

Managing today’s global trials requires an advanced, easy-to-use, and flexible CTMS that can deliver significant cost savings while improving execution.

Modern clinical trial management systems on a unified platform eliminate silos and improve study visibility to effectively manage your trials. Role-based dashboards provide real-time insights, enabling users to take action at the point of decision without logging in and out of multiple systems. Configurable reports help identify and resolve issues immediately.

For example, role-based dashboards and a unified view across study activities make the monitoring process more efficient by better preparing CRAs to conduct study initiation visits and follow-up activities. This enables CRAs to prioritize critical tasks, track enrollment status for each site, and review open issues and missing documents. They can resolve issues and request missing documents without leaving the system.

With a real-time view across end-to-end clinical trial processes, a modern CTMS can help you:

• Plan, track, and mitigate potential subject enrollment bottlenecks
• Seamlessly collaborate with study team members
• Identify and shut down low-enrolling and no-enrolling sites
• Proactively identify issues and take corrective action

Enhancing clinical data quality

Unifying trial documents and operational data in a single system centralizes clinical processes, improves accuracy, and enables strategic planning. For example, if study team members can see all the information for an upcoming site initiation visit, they can prioritize their tasks in the optimal sequence. This might mean developing and reviewing a contract, then gathering documentation for an investigational medicinal product release, and finally briefing the monitor who will conduct the study initiation visit.

Selecting the right CTMS for your business

When searching for the right CTMS for your business needs, look for a full-featured, process-based solution. Some key features include:

• Future-proofed trials: The right CTMS scales with you and supports both insourced and outsourced operating models.
• Unified platform: The right CTMS is a central hub that easily connects with other clinical systems, eliminating costly integrations and facilitating seamless data exchange.
• Continuous innovation: Modern cloud CTMS delivers continuous innovation and system upgrades, ensuring the system can support your evolving trial needs.

Modern study management for faster clinical trials

CTMS is central to a unified clinical operating environment, bringing together data, business processes, and system workflows to achieve operational improvements.  CRAs can author and automatically file monitoring visit reports (MVR) in eTMF, shortening filing time and improving eTMF completeness. CTMS also simplifies regular protocol deviation reviews and action item management, enabling faster decision-making and keeping studies on track.

The Vault CTMS difference

Flexible

Easily support different operating models and study-specific needs in one system.

Unified and connected

Work seamlessly across data and documents and reduce integrations to drive cross-functional efficiencies.

Enhanced analysis and insights

Interactive dashboards allow users to move directly from insight to action to optimize trial performance.

“One of the most important criteria was having a single source of truth so we could easily pull data together in one place to reduce errors. My sleepless nights stopped when we made the business decision to implement Veeva Vault CTMS.” Susan Stamford, Executive Director of Clinical Operations
Heron Therapeutics

See case study