Clinical Trial Software – The Ultimate Guide

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

Chapter 1

Introduction

Introduction

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.

Chapter 2

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 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.

Webinar:
The Business of Clinical Trials
Chapter 3

Capabilities: Financial

Capabilities: Financial

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.

Webinar:
Effectively Managing Clinical Trial Receivables
Chapter 4

Capabilities: Compliance

Capabilities: Compliance

With patient data security and safety concerns on the rise, it’s crucial for research organizations to monitor all facets of the clinical trial process closely to ensure that regulatory compliance is maintained. Using clinical trial software, organizations can stay on top of compliance.

Billing

Clinical trial software applications offer a plethora features to that help organizations achieve compliance while streamlining billing processes, including:

  • A cost allocation grids to record Medicare Coverage Analysis decisions and justifications for each study procedure
  • A billing review workflow, enabling the user to validate study research charges for correct payer designations, consistency with hospital billing data, and approval of research charges for sponsor invoicing.
  • An EMR integration of the billing grid, ensuring that the hospital billing allocations are current and accurate.

Research

Navigating clinical research compliance can be a complicated and extensive process. Clinical trial software allows clinical research organizations to stay on top of research compliance in a number of ways, including:

  • Employee scheduling and communication, allowing the research team to stay in constant communication throughout every step of the research process.
  • Automation of administrative workflow processes, ensuring that all patient history paperwork is filed consistently and is easily accessible
  • Robust reporting tools that allow clinical research organizations to identify any clear problem areas or bottlenecks in the research process that may be posing a compliance risk
Blog Post:
The Research Compliance Maze - Play It Safe
Chapter 5

Capabilities: Project Management

Capabilities: 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.

Webinar:
Optimizing your Research Program: Best Practice Approaches to Structure and Staffing
Chapter 6

Capabilities: Recruitment

Capabilities: Recruitment

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. 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:

  • Patient information database that allows researchers to create potential call lists
  • Call center workflow management
  • Web and social recruitment integrations that allow research sites to easily find and target potential patients
  • Text messaging that allows researchers to easily communicate appointments and other pertinent information in an accessible fashion

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 improve participant pool accuracy and patient retention rates.

Webinar:
Patient Recruitment 101: Tips for a Successful Campaign
Chapter 7

What to look for in a CTMS

What to look for in a CTMS

“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.”

 

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.

Chapter 8

Finding the Right Clinical Trial Software

Finding the Right Clinical Trial Software

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.

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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