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Is Your eTMF System & Business Process Working?

The eTMF Health Check from Daelight Solutions is a joint system and process review of your organization’s eTMF configuration and usage. This evaluation considers business needs, industry best practices, and regulatory requirements regardless of what eTMF system you use. Complete the questionnaire below to begin.

How Does the eTMF Health Check Help?

eTMF management is more than just seeing what files are present and which are missing. It’s a look at how those documents get into the system, how the eTMF system is configured and who is involved in the process.

An eTMF Health Check looks at the whole picture and then makes recommendations and develops materials based on the findings in the end-to-end process and systems review.

You can also deploy the eTMF Health Check to review your partnered technology and ensure compatibility with your processes and expectations.

The outputs of the eTMF Health Check will vary from sponsor to sponsor depending upon the complexity of their needs.

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Who Is the eTMF Health Check For?

Our eTMF Health Check is the perfect service for eTMF Managers, System Administrators, and Owners who want to make the most out of their eTMF investment.

How Long Does the eTMF Health Check Take?

The duration of the eTMF Health Check can vary depending on the complexity of your system. In general, it will take 4-6 weeks to review your process/systems. Any document outputs that are generated as a result of the Health Check findings will take additional time.

Check Your eTMF Health
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Assess Your eTMF in 2 Stages

Your eTMF is unique, which means there’s no one-size-fits-all approach to improving its performance. That’s why our experts analyze your eTMF in two distinct stages. With a better understanding of your system’s operations, we can provide actionable recommendations to boost functionality, including:

  • eTMF system configuration changes

  • Standardization of the sponsor’s TMF index

  • Development of a sponsor-specific TMF Plan Template

  • Training and change management
  • The need for a TMF Oversight Plan where you use a CRO’s eTMF system
  • SOP revisions
  • Defining KPIs

Stage 1: eTMF System Analysis

Is your eTMF operating effectively? If you aren’t sure, we can help by looking over your current performance. Here’s how we do it:

  • Assess current state deployment against best practices
  • Analyze metrics and reporting usage
  • Identify areas of automation
  • Review feature use and recommend best practices
  • Identify methods to increase user adoption
  • Identify areas for efficiency gains

Stage 2: eTMF Process Analysis

Next, we will review your eTMF process and look for ways to streamline operations. This comprehensive analysis involves:

  • Check utilization of approved SOPs
  • Review Quality Review Processes and identify ways to reduce complexity and resource burden
  • Review change and release management processes
  • Evaluate user administration practices
  • Identify areas for process simplification

Benefits of the eTMF Health Check

Our eTMF Health Check offers several advantages for your system and process.

check your etmf health
  • Improve the performance and reliability of the eTMF system
  • Increase user adoption of the eTMF system
  • Improve the efficiency of eTMF management processes
  • Enhance regulatory compliance

Post-Health Check

Your partnership with Daelight Solutions doesn’t stop with the eTMF Health check. The Daelight TMF Services Team applies deep knowledge of regulation and best practices across the TMF Management space. Our team of experts can assist you from start to finish, from system implementations and document processing to technical migrations, inspection readiness checks and system administration. The TMF is the story of your clinical trial; make sure it’s ready to tell.

TMF Toolkit

Utilize our tools and templates to stay compliant and set yourself up for success.

TMF Expertise on Demand

Partner with our TMF experts to oversee your TMF management practices when needed.

System Implementation and Migration

Setting up and moving to a new Vault eTMF is easy when you work with our team.

System Administration

Let us manage your eTMF throughout all stages of deployment and maintenance.

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Save Money with Our TMF Experts

As part of our TMF Expertise on Demand offering, we can save you money by serving as your TMF team.

For example, after we performed an eTMF Health Check for a client, they contracted one of our experts as a resource to serve as the internal, one-person TMF department.

This saved the client money from having to hire a full-time employee and allowed them to work with a professional who understood their system inside and out.

Who Is Daelight Solutions?

Daelight Solutions is a life sciences business and technology consultancy that helps companies with system implementations, integrations, migrations, and business process analysis across every stage of the drug development lifecycle.

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Frequently Asked Questions

An electronic trial master file (eTMF) is a digital system used to manage the documentation required for clinical trials. It ensures that all trial-related documents are stored, organized and accessible in a secure, compliant and easily retrievable manner to facilitate regulatory compliance and efficient trial management.

There are many eTMF systems available on the market, each varying in their functionality and interoperability with other clinical systems, such as a Clinical Trial Management System (CTMS). The following is a list of some of the available eTMF systems. Please keep in mind that this list is not exhaustive, and the order does not represent Daelight Solutions’ preference for one system over another:

  • Veeva Vault eTMF
  • TransPerfect Trial
  • Interactive
  • PhlexGlobal
  • PhlexTMF
  • IQVIA Wingspan
  • Montrium eTMF
  • Connect
  • Kivo eTMF
  • Viedoc eTMF
  • Medidata Rave eTMF

The answer is yes. Can you imagine trying to manage large volumes of information on paper? An eTMF is crucial to be able to track study events and data from the initiation to the closure of a clinical trial. It’s an essential tool for ensuring regulatory compliance, maintaining organized and accessible documentation and supporting audits and inspections.

Absolutely. Whether you are selecting your first eTMF system or migrating from one solution to another, you can count on Daelight Solutions to help you balance finding the right-sized software solution that fits both the functional and financial needs of your business.