Working Smarter: Implementing a CTMS in Clinical Trials

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Working Smarter: Implementing a CTMS in Clinical Trials


The conduct of clinical research is becoming increasingly more involved, presenting challenges that require a strategic, global approach that doesn’t just manage processes, but streamlines them for clinical trial sites as they helm their day to day operations and look to scale the scope of their business. A robust CTMS (clinical trial management system) provides a comprehensive application that drives the bottom line: “Due to the inherent complexity of clinical trials, their budgets are unique and difficult to predict and manage. A trial budget changes constantly, much like the clinical trial itself…many budget managers are not well-versed in how to track financials effectively.” ( Implementing a CTMS has distinct advantages that organize and bolster clinical research sites’ end-to-end management of:

  1. Accounting and Budgeting
  2. Reports and Study Documents
  3. Patient Database Management
  4. Patient Recruitment
  5. Other affiliated tasks

Before we delve into the particulars, there are initial questions to ask before selecting a CTMS vendor.

In order to determine which CTMS to choose, it’s important to ask the right questions. What are your site’s top priorities for implementing a CTMS? You don’t want to settle for a platform that is not going to meet your site’s specific needs. How easily will the CTMS incorporate into existing workflows, and how burdensome will it be for research staff to adapt to it? Thinking about cost is a two-fold issue; there is the monetary expense as well as the time it takes to get processes up and running. Another consideration is integration with other platforms, such as email and payment platforms. Once you have researched all the options, you’ll be able to make an informed decision and begin to reap the benefits of using a CTMS.

  1. Accounting and Budgeting

A CTMS tracks revenue, costs and profitability. It also allows for invoice creation for completed/monitored visits or other study revenue items as needed. Another useful feature to look for is the ability to build budget templates according to the study event schedule.


  1. Reports and Study Documents

Financial study reports detail study earning costs and profitability. In addition, financial data can be tracked by coordinator, investigator or the entire company, allowing for key insights into the business. A CTMS can track allocation of advertising budgets and provide detailed reporting on where the money is going. Study documentation can also be uploaded for easy access by the entire site staff that can be accessed from any location.

  1. Patient database management

Searches can be conducted based on highly customizable, multiple demographic criteria such as age, gender, and inclusion/exclusion conditions and medications. The CTMS also streamlines feasibility questionnaire completion by allowing for an easy way to parse through your patient database.

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  1. Patient Recruitment

Communication with targeted patients is facilitated through email or a print-based call sheet and the status of patients through the patient funnel can easily be tracked.  A CTMS can allow you to analyze each marketing tactic utilized during a study to get metrics on ROI including total spend and cost per randomization.

  1. Other Affiliated Tasks

A CTMS can keep track of upcoming and overdue visits, progress notes for each patient and pending subject recruitment activities.  CTMS platforms are also able to connect with electronic regulatory records and electronic source, key integrations that will set your site up for success.

Don’t settle for less than what you need. Select the best CTMS platform for your organization by doing thorough research, taking into consideration data driven, operational needs as well as your site’s staff and current workflows. Choose a system with an eye towards future growth and global trends in clinical research. For additional guidance on this issue, contact a BTC specialist.

Melissa Daley

Post by Melissa Daley -

Melissa develops social media and digital marketing content strategies and produces a variety of collateral with creative, effective messaging. Melissa has served as an educator in higher education for close to two decades.

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