{"id":39496,"date":"2021-02-18T07:49:00","date_gmt":"2021-02-18T12:49:00","guid":{"rendered":"https:\/\/arisglobal.com\/?p=39496"},"modified":"2021-02-18T07:49:00","modified_gmt":"2021-02-18T12:49:00","slug":"electronic-trial-master-file-master-etmf-systems-tell-story-covid-19-vaccines","status":"publish","type":"post","link":"https:\/\/www.arisglobal.com\/blogs\/electronic-trial-master-file-master-etmf-systems-tell-story-covid-19-vaccines\/","title":{"rendered":"Electronic Trial Master File (eTMF) Systems Tell Compelling Story of COVID-19 Vaccines"},"content":{"rendered":"

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.<\/span><\/span>\u00a0<\/span><\/span>These\u00a0<\/span><\/span>eTMF\u00a0<\/span><\/span>systems manage critical documents that tell the story of a clinical trial. In the case of Covid-19<\/span><\/span>\u00a0vaccines, eTMF systems tell a dramatic tale.<\/span><\/span>\u00a0<\/span><\/span><\/p>\n

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<\/span><\/span>\u00a0anxiously<\/span><\/span>\u00a0to see just how the industry would react. <\/span><\/span><\/span><\/p>\n

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<\/span><\/span>\u00a0– a<\/span><\/span>nd that was in the 1960s.<\/span><\/span>\u00a0<\/span><\/span>After so many years, how were companies finally able to deliver two vaccines in less than a year?\u00a0<\/span><\/span>Apart from the massive financial investment,\u00a0<\/span><\/span>drastic technological advancements<\/span><\/span>\u00a0changed the game<\/span><\/span>.\u00a0<\/span><\/span>First,\u00a0<\/span><\/span>mRNA technology supercharged Covid-19 vaccine development<\/span><\/span>. A<\/span><\/span>dditionally,\u00a0<\/span><\/span>cloud-hosted\u00a0<\/span><\/span>technologies such as<\/span><\/span>\u00a0the<\/span><\/span>\u00a0<\/span><\/span>ArisGlobal<\/span><\/span>\u00a0LifeSphere<\/span><\/span>\u00a0electronic Trial Master File (eTMF) system<\/span><\/span><\/a>\u00a0accelerated clinical operations.\u00a0<\/span><\/span>\u00a0<\/span><\/span><\/p>\n

Electronic Trial Master File (eTMF) Systems Enable Faster Yet Safe Clinical Development<\/h2>\n

The people who developed Covid-19 vaccines in less than a year offer important lessons for those dedicated to\u00a0finding cures for all diseases.\u00a0First,\u00a0drug development can\u00a0go much faster and not\u00a0compromise\u00a0safety.\u00a0Electronic Trial Master File (eTMF) systems play a role in this safe acceleration.\u00a0They are built to\u00a0reduce human error\u00a0when\u00a0managing\u00a0the Trial Master File.\u00a0Clinical operations directors using eTMF\u00a0systems\u00a0in Covid-19 trials\u00a0were ready to handle the increased risk\u00a0of\u00a0moving at warp speed.\u00a0<\/span><\/p>\n

Secondly,\u00a0decentralized trials are here to stay. The pandemic forced more clinical trials to\u00a0go\u00a0remote. Clinical operations directors who\u00a0innovated with\u00a0electronic Trial Master File (eTMF)<\/a>\u00a0and\u00a0clinical trial management systems (CTMS)<\/a>\u00a0were prepared to support more remote monitoring visits, manage decentralized\u00a0studies,\u00a0and deliver breakthrough cures. Those that struggled to adopt these technologies stumbled and saw study delays increase.\u00a0\u00a0<\/span><\/p>\n

By having unified CTMS<\/a> and eTMF<\/a> systems in place, Covid-19 innovators were ready to start trials faster and prepare a compliant filing plan from day one.\u00a0\u00a0<\/span><\/p>\n

 <\/p>\n

eTMF Systems Empower Clinical Operations to Write a New Chapter in Drug Development<\/h2>\n

Clinical operations innovators\u00a0have\u00a0learned how to gain momentum,\u00a0maintain\u00a0patient safety and data integrity,\u00a0and avoid critical inspection findings. A poorly designed or outdated TMF management process can result in large fines, delays in approval by health authorities, and\u00a0excessive costs\u00a0to resolve errors.\u00a0\u00a0<\/span><\/p>\n

With\u00a0LifeSphere electronic Trial Master File (eTMF) system\u00a0in place,\u00a0there are 5 ways\u00a0clinical operations directors can\u00a0improve timeliness, quality, and completeness.\u00a0<\/span><\/p>\n