Clinical Trial Software – The Ultimate Guide

Learn how clinical trial software revolutionizes the way you conduct your clinical research.

CTMS - Clinical Trial Management Software


Introduction to Clinical Trial Software

Clinical research organizations are faced with a number of challenges in today’s global life sciences marketplace. Managing multiple clinical trials in a compliant and efficient manner requires airtight, end-to-end transparency throughout all facets of the process, including financial data, patient care, compliance with federal regulatory standards, and employee scheduling. Now more than ever, healthcare organizations need to be proactive when addressing these challenges. Excel sheets don’t exactly make the cut anymore.

To be proactive and agile, health care organizations need to know what they are dealing with. In the face of workplace bottlenecks, such as siloed information and disconnected systems, it can be challenging to get a clear picture of the state of an organization’s clinical research management process.

Without a coherent and standardized clinical trial management process, clinical research organizations (CRO), research sites, hospitals, and health systems are in danger of letting vital data slip through the cracks and allowing unseen bottlenecks to compromise the efficiency and regulatory compliance of their trials and patient safety. But how can operations executives improve inefficiencies they cannot see? Like the old adage goes, knowledge is power. To achieve a transparent, end-to-end clinical trial management process, organizations look to clinical trial software.

What is Clinical Trial Software?

What is Clinical Trial Software?

Clinical trial software provides thorough, standardized management throughout the lengthy clinical trial process, helping organizations with:

  • Site performance management and reporting
  • Team collaboration
  • Management of supply chains
  • Regulatory document management

From protocol development to analysis completion, clinical operations executives can look to clinical trial software to glean critical insights and uncover opportunities regarding the clinical trial process, apparent bottlenecks, and the state of regulatory compliance. Using these insights, research organizations can adjust their clinical trials to become more agile and improve the level of patient care provided.

Clinical trial software offer robust capabilities in four major areas for health care organizations:

Utilizing clinical trial software allows research organizations to transcend the common pitfalls of traditional clinical research trial processes. As trials become more complex and the clinical research trial process becomes increasingly global, clinical trial software is integral to maintaining a thorough and transparent system.

Capabilities: Financial

Increased Profitability

For many clinical research organizations, viewing their organization through the lens of a business is a challenge in and of itself. Because research is a process that sites conduct to reach conclusions about certain drugs or treatments, incorporating business intelligence into that process can feel like a foreign concept. Now more than ever, there is a need for actionable business insights within clinical research organizations. Trials are becoming increasingly complex, the patient recruitment process is challenging, and shrinking study budgets equals a downright costly operation.

It is crucial for research organizations to maintain thorough and accurate reporting throughout the entire clinical research process. In doing so, operations executives will be able to control the cost of the clinical trial process.

When looking to improve the success of a clinical research organization, operations executives need a way to test their current practices. Using clinical trial software, organizations can monitor and report the success or inefficiencies of the following areas of clinical trial processes:

Overall program/profit loss

Using clinical trial software, operations executives can easily look at their bottom line and discern whether or not their trials are operating at their utmost efficiency

Individual trial profit

These reports offer the critical breadcrumbs that will direct an organization to the path of success, allowing them to filter out bad trials and find the ones that are bringing in profit

Clinical Trial Program Cost Recovery

Once organizations have addressed what isn’t working in their clinical trials, it’s likely that their budget will change shape. As this happens, program cost recovery reports will help ensure that recovered costs will be accounted for

Patient Enrollment

Patient enrollment tracking helps organizations understand the patterns of the patient enrollment process, allowing more successful future trials. Patient enrollment reports offer insight on the maximum ROI and the most powerful methods for niche recruitment

Upcoming Business

As new business prospects approach, these reports help organizations make long-term business decisions regarding materials, personnel, space, and more, helping employees stay on-task and trials running smoothly

Staff Capacity

Organizations can use visits scheduled and completed in order to determine the workload that team members are carrying, allowing managers to make necessary adjustments and increase productivity

Utilizing clinical trial software provides countless insights that will help research organizations maximize profits. However, clinical operations executives need to ensure that they are maximizing the breadth of their clinical trial software’s capabilities by developing clear, actionable business insight goals.

Clinical trial software is often equipped with Business Intelligence modules, allowing research organizations to get the answers they need with unparalleled access to real-time business data with the ability to create actionable reports almost instantaneously.

Capabilities: Project Management

Project Management

Project management is the process of planning and maintaining an organization’s clinical trial resources throughout the entire clinical trial process. Maintaining tight control of these resources is essential in ensuring the trial is completed on time, on budget, and with quality and accuracy. A clinical trial software allows clinical research organizations to manage all facets of the clinical trial planning and management process seamlessly.

Clinical trial software project management features include:

  • Financial tracking
  • Partner selection
  • Partner supporting and metrics
  • Monitoring and protocol management

With CTMS, project management tools are integrated into one easy-to-use application, making communication, planning and execution a no-brainer.

Project management features automate and standardize the clinical research trial process, allowing for clinical research organizations to identify and eliminate weaknesses in their project management system. This leads to less confusion, enhanced communication, better collaboration and faster trial progression.

Capabilities: Recruitment

Faster Enrollment

As clinical research continues to expand its global reach, research organizations are faced with a unique paradox: while there are more patients at their fingertips than ever, it is more challenging to maintain organized and integrated system recruitment and enrollment. Clinical trial management software can help organizations find new participants and maintain their information in one centralized location.

Clinical trial software offers a number of recruitment features, including:

Aided by the use of social media tools such as Facebook ads, research organizations can really hone in on the specific traits desired for a research participant and use the site’s demographics information to find the ideal patients for recruitment.

Utilizing a CTMS’ features to aid recruitment efforts helps to enhance participant pool accuracy, measure outreach efficacy, and patient retention rates.

What To Look For In A CTMS

Site Selection

“Because every sponsor and CRO have a different business model mode of operation, no single out-of-the-box CTMS product is likely to satisfy the majority of business management needs of any organization.”Beth Harper, IT World

Not all Clinical Trial Management Systems are created equal. The right clinical trial management software can help organizations achieve utmost efficiency and success. Adopting the wrong clinical trial software, however, can make clinical trials even more trying of a process.

In order to find the right clinical trial software, organizations need to have a grasp on the current state of their clinical research organization, having clear answers to the following questions:

  • Who is involved in the decision-making for CTMS adoption?
  • What is our budget?
  • Which parts of our clinical research trial system work well? Which are inefficient?
  • What are the goals of our organization?
  • What kind of actionable data do we need in order to achieve our goals?

If clinical research organizations are having a difficult time discerning where their challenges and strengths lie, it is helpful to list every step of the process, analyzing each part of the system to monitor which operations are a breeze and which are a drain on time and resources.

From there, clinical research organizations can begin to form a picture of what their concrete needs are and can begin comparing clinical trial software.

Finding the Right Clinical Trial Software

Enhanced Visibility

At a baseline, effective clinical trial software should improve patient safety/experience, limit administrative burdens, and should improve communications between organizations within a clinical research organization. But this is just the tip of the iceberg.

When finding the right clinical trial software, clinical research organizations should consider the following factors:

1. Clinical Trial Software Compatibility

Clinical research organizations employees need to be able to access the clinical trial software from a number of locations throughout their sites. The clinical trial software hosting architecture should be robust enough to work efficiently from any location or device.

2. Compliance

Clinical trial software hosting should meet all requirements imposed by HIPAA and other regulatory bodies. In addition, the clinical trial software should be agile enough to adapt in the face of shifting compliance regulations.

eClinical is a bundle of integrated applications that include CTMS and increase accuracy of information, efficiency of data gathering and sharing, ease of regulatory management and other aspects of clinical trial site management. Working together, these applications allow sites to digitize and automate clinical operations management under one convenient umbrella. eClinical components each perform specific functions and are a powerful tool to address many needs within an operation. These components include:

  • eSource: Through direct digital collection of data, this tool creates an original record of important information, leading to greater accuracy and efficiency.
  • eRegulatory: While regulatory information normally is stored in unwieldy binders, this solution digitizes the data and houses it in a user-friendly digital infrastructure, making it easier to use and less space-consuming
  • eConsent: This obtains a patient’s informed consent through an easy-to-use interface.

3. Database Management

Clinical trial software should maintain thorough records of all medical, medication, and social histories of patients. It should also allow clinical research organizations to maintain contact with patients.

4. Patient Capture

Does the clinical trial management software allow clinical research organizations to track leads easily and efficiently and offer social integration and call workflow management in order to add patients to growing databases?

5. Marketing/Remarketing Features

Does the clinical trial software allow clinical research organizations to market to potential patients easily, leveraging marketing assets such as email, Facebook integration, and website integration?

6. Client/Patient Communication & Scheduling Capabilities

Whether it involves inter-organization communication or patient outreach, clinical trial software should offer a built-in scheduling and communication system that makes for a more seamless workflow.

7. Study Set Up and Management

Is the clinical trial management software able to quickly arrange all components of the clinical trial in one unified location?

8. Financial Management

Clinical trial software systems should be able to track all budgets and payments using a single solution. Additionally, it should be able to set and monitor budgeting, maintain invoices and manage payables/receivables.

9. Reporting

Clinical trial software should offer robust reporting capabilities, giving clinical research organizations and research sites the tools they need (such as level 3 and 4 NCI reporting) to run reports in real-time, furthermore allowing them to turn data into actionable tasks.

10. Document Management

Electronic document capture and management are crucial to maintaining a seamlessly integrated and organized clinical research trial process.

11. Available Integrations

Depending on the needs of a clinical research organization, clinical trial software may require integration capabilities that allow for organizations to achieve an even more robust clinical research management system.

Finding the right Clinical Trial Management Software can be a rigorous process in and of itself. But a well-integrated system can spell the difference between success and disaster for Clinical Research Organizations.

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