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INTUITIVE eTMF SOLUTIONS WITH UNMATCHED EFFICIENCY AND INTEGRATION

Enhance your Clinical Trials with a New Generation of eTMF

  • NSeamless integration with EDC, CTMS, RTSM
  • NReal-time reporting and inspection readiness
  • NIntuitive and user-friendly
  • NUnparalleled efficiency and transparency
Intuitive eTMF solutions with unmatched efficiency and integration

Enhance your Clinical Trials with a New Generation of eTMF

  • NSeamless integration with EDC, CTMS, RTMS
  • NReal-time reporting and inspection readiness
  • NIntuitive and user-friendly
  • NUnparalleled efficiency and transparency

Transform your trial management with eTMF setup and administration services

Our eTMF services are designed to streamline the management of clinical trial documentation, ensuring compliance, efficiency, and collaboration throughout the trial lifecycle. From its setup to closure, we offer reliable and compliant eTMF solutions tailored to your unique needs.

Elevate your clinical trial documentation management with our comprehensive suite of eTMF services.

Speak to an expert

Main areas of eTMF setup and administration

Unlock the potential of our service offerings

Our eTMF service encompasses a comprehensive range of activities, including the precise creation of eTMF plans, the development and implementation of eTMF structures within our unified oomnia clinical research software, and proficient eTMF management and administration throughout the study’s lifecycle. Our adept team excels in both CDISC TMF reference model and ISO 14155 standard, ensuring that the primary aim is met: strict adherence to pertinent regulatory mandates and audit readiness.

eTMF plan creation

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Our service ensures a personalized approach, tailoring the TMF plan to the specific needs and complexities of your study and standard operating procedures. We work closely with your team to capture the unique aspects of your trial within the eTMF plan. Our eTMF specialists will help you to define a comprehensive strategy for document collection, filing, approval, and quality control.

eTMF training and trial specific user manuals

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Our training programs cover a wide spectrum of aspects, ranging from the seamless upload of documents to the proficient management of these documents. We are committed to equipping your team with the necessary expertise to harness the full potential of your eTMF. To facilitate this, we offer meticulously crafted, trial-specific user manuals that provide a comprehensive reference guide. These resources, combined with our intuitively designed software interface, culminate in an exceptional and user-friendly experience for our clients.

Quality control

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Our comprehensive quality control services ensure the integrity and reliability of your trial documentation. A dedicated Wemedoo team conducts systematic and thorough assessments, performing regular checks to rigorously verify accuracy, completeness, and compliance within your eTMF. With an unwavering commitment to upholding the highest standards, we diligently ensure that your electronic Trial Master File remains error-free and audit-ready at all times.

User access management

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Our specialized services extend to the rigorous management of user access and permissions within the eTMF, aligning seamlessly with your organizational hierarchy and structure. With our comprehensive solutions, you gain the ability to finely tune document visibility and editing privileges. This ensures a precise level of control over the eTMF system's functionalities. Also, it reinforces compliance with your organization's specific requirements and regulatory standards, fostering a secure and structured environment for your clinical trial documentation.

eTMF structure creation and implementation

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Our diligent team offers invaluable support in the development of your eTMF structure, ensuring that it aligns seamlessly with your study's individual requirements and complies with the highest industry standards. Additionally, we specialize in the precise setup and configuration of the eTMF system, tailoring it to the specific eTMF structure and access levels that your study demands. This comprehensive service is designed to streamline your document management processes and enhance the overall efficiency and compliance of your clinical trials.

Ongoing support and maintenance

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Our dedicated support team is committed to providing timely assistance, addressing any technical issues, and ensuring continuous improvement through proactive maintenance services. Any modifications are handled in a professional and timely manner, with little or no impact to daily eTMF operations.

Real-time integrated graphical reporting

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Our advanced technology empowers you to gather comprehensive data on eTMF completeness and quality, allowing for more informed decision-making in your clinical trial management. Utilize our cutting-edge, real-time integrated graphical reporting and analysis tools to gain deeper insights into the comprehensiveness and quality of your eTMF.

System upgrades and enhancements

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Our regular updates and continuous enhancements empower you to stay ahead of the curve. We are committed to fine-tuning the eTMF system, incorporating new features, enhancing its performance, and proactively addressing the ever-evolving regulatory landscape. Therefore, we ensure you remain at the forefront of industry advancements.

eTMF plan creation

:
;

Our service ensures a personalized approach, tailoring the TMF plan to the specific needs and complexities of your study and standard operating procedures. We work closely with your team to capture the unique aspects of your trial within the eTMF plan. Our eTMF specialists will help you to define a comprehensive strategy for document collection, filing, approval, and quality control.

eTMF training and trial specific user manuals

:
;

Our training programs cover a wide spectrum of aspects, ranging from the seamless upload of documents to the proficient management of these documents. We are committed to equipping your team with the necessary expertise to harness the full potential of your eTMF. To facilitate this, we offer meticulously crafted, trial-specific user manuals that provide a comprehensive reference guide. These resources, combined with our intuitively designed software interface, culminate in an exceptional and user-friendly experience for our clients.

Quality control

:
;

Our comprehensive quality control services ensure the integrity and reliability of your trial documentation. A dedicated Wemedoo team conducts systematic and thorough assessments, performing regular checks to rigorously verify accuracy, completeness, and compliance within your eTMF. With an unwavering commitment to upholding the highest standards, we diligently ensure that your electronic Trial Master File remains error-free and audit-ready at all times.

User access management

:
;
Our specialized services extend to the rigorous management of user access and permissions within the eTMF, aligning seamlessly with your organizational hierarchy and structure. With our comprehensive solutions, you gain the ability to finely tune document visibility and editing privileges. This ensures a precise level of control over the eTMF system's functionalities. Also, it reinforces compliance with your organization's specific requirements and regulatory standards, fostering a secure and structured environment for your clinical trial documentation.

eTMF structure creation and implementation

:
;
Our diligent team offers invaluable support in the development of your eTMF structure, ensuring that it aligns seamlessly with your study's individual requirements and complies with the highest industry standards. Additionally, we specialize in the precise setup and configuration of the eTMF system, tailoring it to the specific eTMF structure and access levels that your study demands. This comprehensive service is designed to streamline your document management processes and enhance the overall efficiency and compliance of your clinical trials.

Ongoing support and maintenance

:
;
Our dedicated support team is committed to providing timely assistance, addressing any technical issues, and ensuring continuous improvement through proactive maintenance services. Any modifications are handled in a professional and timely manner, with little or no impact to daily eTMF operations.

Real-time integrated graphical reporting

:
;

Our advanced technology empowers you to gather comprehensive data on eTMF completeness and quality, allowing for more informed decision-making in your clinical trial management. Utilize our cutting-edge, real-time integrated graphical reporting and analysis tools to gain deeper insights into the comprehensiveness and quality of your eTMF.

System upgrades and enhancements

:
;
Our regular updates and continuous enhancements empower you to stay ahead of the curve. We are committed to fine-tuning the eTMF system, incorporating new features, enhancing its performance, and proactively addressing the ever-evolving regulatory landscape. Therefore, we ensure you remain at the forefront of industry advancements.

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Benefits of our service

Learn more about the advantages of our efficient eTMF service

Employing Wemedoo’s eTMF service in clinical trials brings a multitude of advantages crucial for the success of your clinical trial document management. Whether you are running a small-scale study or a complex, large-scale trial, our eTMF services are designed for scalability. This allows clinical data managers, trial directors, study coordinators, clinical research associates to grow with confidence, knowing that our solutions adapt to meet the evolving needs of your trials.

Seamless compliance

Our eTMF services ensure unwavering adherence to Good Clinical Practice (GCP) standards, reducing compliance risks. This enhances the success of your clinical trials.

Data Security

Our eTMF services prioritize data security, instilling confidence in your trial documents’ integrity. With advanced security measures and encryption, we ensure peace of mind in your clinical research.

Audit Readiness

Our meticulous and thorough documentation approach ensures that you are always well-prepared for audits and inspections, allowing you to navigate regulatory scrutiny with confidence and ease.

Comprehensive Support

Our dedicated team offers end-to-end support exclusively tailored to your needs. We assist you at every stage of your trial. From initial setup to ongoing administration and compliance, we ensure a seamless and successful eTMF journey.

Eager to explore tailored services?

Discover how our clinical trial services can revolutionize your research. Take the first step towards unmatched trial efficiency and success today.

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Frequently asked questions

Get the answers you need about our eTMF services

What do Wemedoo eTMF setup and administration services include?

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Our eTMF service refers to the processes and activities associated with the TMF plan creation, development of the eTMF structure and its implementation in our oomnia system, as well as eTMF setup and management, and ongoing support.

How does Wemedoo ensure compliance with international regulations?

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We stay updated with the latest regulatory changes and implement strategies to ensure full compliance with international standards.

What makes Wemedoo eTMF reporting efficient?

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Our advanced system provides users with real-time eTMF completeness and eTMF quality reports. This means that users can quickly review the status of essential documents and compliance metrics, enabling timely decision-making.

Can Wemedoo eTMF service adapt to different phases of clinical trials?

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Absolutely, our eTMF services are versatile and can be tailored to meet the specific requirements of various phases of clinical trials.

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Learn more about how we can support your cinical trials.
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Explore related services

Discover comprehensive solutions for your clinical trial needs

Beyond eTMF setup and administration, Wemedoo offers a comprehensive suite of integrated data operations services for clinical trials. At each step we ensure your trial meets the highest quality and regulatory standards, while streamlining your clinical trial processes. As a consequence, you will save time and money. Discover our other services, all focusing on innovation and excellence in clinical research.
Protocol Development
Clinical Data Management
Risk-Based Monitoring and Source Data Review
Biostatistics and Statistical Programming
CDISC-Compliant Dataset Generation
Medical Writing and Documentation

oomnia – Surpassing Industry Standards

Our unified clinical trial software is designed with compliance at its core, meeting critical industry standards. Our commitment to these regulations ensures that your clinical trials are not only efficient but also adhere to the highest levels of data integrity, privacy, and ethical conduct.

What our clients say

Read more about the experiences from those who have partnered with us

"All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team."

Georg Mathis, PhD

CEO Appeltree CI Group AG

"Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail."
Martina Diminic Smetisko, DMD

Managing Director at Marti Farm Ltd

"Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together."

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

Considering unified clinical trial software?

Experience oomnia, our all-in-one clinical trial software which unifies tools, such as EDC, eSource, RTSM, eTMF, ePRO, eCOA, eConsent, and CTMS. In combination with our professional services we can provide end-to-end support to transform your clinical research.
Explore oomnia tools