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Electronic Trial Master File (eTMF) Systems Tell Compelling Story of COVID-19 Vaccines

The rapid development of Covid-19 vaccines may lead more drug developers to increase their speed and agility by adopting electronic Trial Master File (eTMF) systems. These eTMF systems manage critical documents that tell the story of a clinical trial. In the case of Covid-19 vaccines, eTMF systems tell a dramatic tale. 

In 2020, the Covid-19 pandemic took center stage and made us rethink life as we knew it. With so many lives at stake, the pharmaceutical industry was forced to be more proactive and innovative than ever before. With all eyes squarely on pharma and medicine, people waited anxiously to see just how the industry would react.

The mounting pressure and severity of the situation resulted in two vaccines being produced in less than a year. This is groundbreaking since most vaccines take 7-10 years for production. In fact, the Mumps vaccine held the previous record for speed at 4 years from start to finish – and that was in the 1960s. After so many years, how were companies finally able to deliver two vaccines in less than a year? Apart from the massive financial investment, drastic technological advancements changed the gameFirst, mRNA technology supercharged Covid-19 vaccine development. Additionally, cloud-hosted technologies such as the ArisGlobal LifeSphere electronic Trial Master File (eTMF) system accelerated clinical operations.  

Electronic Trial Master File (eTMF) systems enable faster yet safe clinical development 

The people who developed Covid-19 vaccines in less than a year offer important lessons for those dedicated to finding cures for all diseases. First, drug development can go much faster and not compromise safety. Electronic Trial Master File (eTMF) systems play a role in this safe acceleration. They are built to reduce human error when managing the Trial Master File. Clinical operations directors using eTMF systems in Covid-19 trials were ready to handle the increased risk of moving at warp speed. 

Secondly, decentralized trials are here to stay. The pandemic forced more clinical trials to go remote. Clinical operations directors who innovated with electronic Trial Master File (eTMF) and clinical trial management systems (CTMS) were prepared to support more remote monitoring visits, manage decentralized studies, and deliver breakthrough cures. Those that struggled to adopt these technologies stumbled and saw study delays increase.  

By having unified CTMS and eTMF systems in place, Covid-19 innovators were ready to start trials faster and prepare a compliant filing plan from day one.  

 

eTMF systems empower clinical operations to write a new chapter in drug development. 

Clinical operations innovators have learned how to gain momentum, maintain patient safety and data integrity, and avoid critical inspection findings. A poorly designed or outdated TMF management process can result in large fines, delays in approval by health authorities, and excessive costs to resolve errors.  

 

  

With LifeSphere electronic Trial Master File (eTMF) system in place, there are 5 ways clinical operations directors can improve timeliness, quality, and completeness. 

  • Easily define a compliant TMF structure. 
  • Ensure essential documents are included and filed correctly. 
  • Reduce the chance of human error using advanced automation. 
  • Increase TMF oversight and visibility for all stakeholders. 
  • Quickly update the protocol when responding to rapid change. 

In the last 12 months, like most things related to Covid-19, vaccine development has seen unprecedented change. Clinical operations throughout drug development may never be the same.  

Leading directors of clinical operations are adopting tools such as unified eTMF and CTMS, empowering them to meet the challenges of an uncertain future.  

 

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