eTMF Workflows: Active eTMF to Improve the Quality of Clinical Trials
Date: June 5, 2017 (60 minutes)
There is no "silver bullet" tool to help you ensure the quality of a clinical trial but selecting a proper electronic trial master file (eTMF) solution is one of the keys to success. Many companies use homegrown systems as eTMF solutions, but those lack some vital functionalities to cover the complete TMF Workflow process. They might also not be user-friendly and sometimes they're more complex than necessary. Moreover, when it comes to data archiving it can become very challenging and time consuming to ensure that the structure of the data and all metadata are properly preserved for many years of storage.
Improper organisation of TMF workflows can be a waste of resources for a company, and can put it at a greater risk of non-compliance. Nobody can argue that eTMF data quality can be a big issue. But by having properly organised processes with a system which can facilitate them, eTMF data quality can become your strong point.
In this webinar, we will be covering various aspects of proper organisation of eTMF workflow including:
- How to achieve a balance between rich functionality of a professional eTMF solution and a user friendly system
- How to make eTMF active, reminding users about missing documents
- Making the right files available with just a few clicks
We will also be talking about the Quality Checks and DIA TMF Reference Model and how to make sure the right documents are filed correctly. We will discuss how you can do this in a timely manner without employing extra staff to do the filing and verification, to make sure you are always be audit ready.
To round-up our presentation, we will review how the upcoming European Medicines Agency (EMA) regulations can affect your eTMF workflows.
An active eTMF system can bring a lot of benefits and may even make your life easier, so join us on this webinar to see how!
Keywords: eTMF, Clinical data
Dmitriy Gorichev, CEO, ClinDisc s.r.o.
Dmitriy is a Founder and the Managing Director of ClinDisc s.r.o., a dynamic company of industry professionals, delivering bespoke software products tailored to the customers' needs. He is an active member of ISPE and CDSIC organisations and a participant in the development of TMF Reference Model and Exchange Mechanism standards.
Dmitriy gained Clinical Research experience by working at CROs for more than 10 years. As an IT Manager at Quintiles Inc. he was supporting and developing systems for clinical research facilitating the rapid regional expansion of the company. Then he took an IT Director position at SanaClis s.r.o. where he was deeply involved in development of vast portfolio of services including Data Management and validated management systems to support IMP Logistic operations. The next step was to found ClinDisc s.r.o. where Dmitriy is managing the development of innovative informatics projects interfacing different systems and solving complex integration projects. Currently residing in Edinburg, UK, Dmitry is enjoying an active lifestyle and continuous education.
|THIS PROGRAM IS INTENDED FOR|
Senior professionals from biopharmaceutical companies, CROs and clinical sites working with:
- Clinical data
- Electronic Trial Master File (eTMF / TMF Management)
- Strategic Planning
|OUR XTALKS PARTNER FOR THIS EVENT|
ClinDisc s.r.o. is a dynamic company of industry professionals, delivering software products that tailor the modern technologies to the customers' needs. We are focused on customer satisfaction and passionate about the best user experience possible. With simple and user-friendly interfaces our systems are hiding the complexity of data warehousing, just making sense and solving problems, delivering precise reports when they are required. No matter how complex or simple our systems are, they undergo rigours automated and manual testing and documented quality control to ensure the highest quality and compliance with regulatory requirements.