eTMF Setup & Administration
Compliant Documentation From Day One
Transform Your Trial Management
Our eTMF services streamline trial documentation from setup to closure, ensuring compliance, efficiency, and seamless collaboration — tailored to your needs.
Streamlined Documentation From Setup to Closure
Our Proof of Quality
We are ISO 9001 and ISO 27001 certified. Our commitment to robust information security & superior quality management is at the core of our innovative solutions, ensuring reliable & efficient trial management for our clients.
Main Areas of eTMF Setup & Administration
Our eTMF service covers everything from plan creation to full lifecycle management within the oomnia platform. We align with CDISC, ISO 14155, FDA 21 CFR Part 11, and EMA standards—ensuring secure, compliant, and efficient documentation.
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.
Trusted partners
Global network of partners
Benefits of Our Service
Wemedoo’s scalable eTMF service supports studies of any size, giving your team confidence with flexible, reliable document management that adapts to your trial’s evolving needs.
Learn more about the advantages of our efficient eTMF service
Compliance
We guarantee adherence to Good Clinical Practice (GCP) standards, reducing compliance risks.
Data Security
Our advanced data security measures and encryption ensure the integrity of your trial documents.
Audit Readiness
Stay always ready for audits and inspections with our thorough documentation approach.
End-to-End Support
Our team delivers end-to-end eTMF support, covering everything from setup to compliance, tailored to your trial needs.
Looking for Clinical Trial Support That Fits Your Study?
Explore how our flexible, integrated services can help you accelerate timelines, improve quality, and reduce complexity.
Frequently Asked Questions
Get the answers you need about our eTMF services
What do Wemedoo eTMF setup and administration services include?
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?
We stay updated with the latest regulatory changes and implement strategies to ensure full compliance with international standards.
What makes Wemedoo eTMF reporting efficient?
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?
Absolutely, our eTMF services are versatile and can be tailored to meet the specific requirements of various phases of clinical trials.
Wondering How It All Works?
Learn more about how we can support your clinical trials.
SPEAK TO AN EXPERT Explore Related Services
Beyond protocol development, 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 and saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.
Resources
eTMF setup resources
eTMF Setup & Administration
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oomnia - Meeting 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.
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See 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 Appletree 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...
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
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their...
Wemedoo's cross-functional, integrated teams capture EDC set-up, go-live, data capture, data cleaning, and finally data analysis in a globally compliant fashion supporting trials in different geographies including the US. Their speed of addressing customer needs sets in my personal experience industry benchmark whilst keeping these data solutions lean and affordable. Besides the great proprietary systems they use, their integrated team approach with personal responsibility and honest commitment to targeting outcomes differentiates the Wemedoo team from other providers. Wemedoo only made Oxular's key initial trial, a device-drug trial possible, as based on some pre-work, the Wemedoo team could substantially adapt and update the first EDC ideas for a trial under a US FDA IND. The Wemedoo team worked extremely focused on familiarizing US trial sites and clinical CROs with the use of their system, which turned out to be a key success factor of the respective trial. The highly professional and up-to-date capabilities in data sciences were mirrored by customer-centricity and super fast timelines of integrating mandatory adaptations to the data systems.
Friedrich Asmus, MD
Chief Medical Officer at Oxular
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions...
Wemedoo's technology, expertise, and intimate engagement with our team in the development of the EDC, site/patient interface, and metric capabilities are unique. They provided insight and challenged the underlying assumptions to ensure the study's goals and objectives were clearly defined and the operating structure matched with the study's intent. Their system is not a one-size-fits-all and they adapt to the needs of the sponsor, sites, physicians, and the study requirements into a system that merges health information/data and can then become not only informative but actionable.
James Kuras
Vice President of Clinical Affairs and Operations at CENTINEL SPINE
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.