New solutions enable enhanced delivery, tracking and management of drug safety reporting and medical questions from sites
The pharmaceutical regulatory landscape is continually evolving, making safety reporting increasingly complex. FIRECREST Safety Letters is supporting sites to manage safety letters and increasing transparency for sponsors. It enables faster sponsor reconciliation of safety letters, both on-site and remotely, that are stored and accessible in one location with single sign-on. The solution also features compound level management, reducing duplication and empowering the principal investigators, or assigned user, to acknowledge safety letter receipt ensuring pharmacovigilance regulatory compliance.
FIRECREST Site Question Management provides medical query routing according to region and role, facilitating faster responses to medical focused questions and providing governance of the process. A record of the interactions and metadata are held centrally in the site portal for oversight purposes and an exportable excel document can be filed in the eTMF.
“The COVID-19 pandemic has highlighted the value of remote clinical management including the use of digital tools. We are delighted to announce the availability of two new FIRECREST solutions that are increasing speed of process and regulatory compliance.” commented
FIRECREST digital solutions drive measureable efficiency and quality in clinical trials and are deployed by 18 of the top 20 pharma with 540,000 users across 233 different indications.
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