Top five largest global CROs moved critical SUSAR notices to certified and secure email notifications with RMail® Registered Email™ service.
RMail Registered Email™ Delivery Proof for Suspected Unexpected Serious Adverse Reaction Notices Transforms Clinical Trial Operations
In clinical trials, sponsors’ standard operating procedures should contain a minimum requirement for expedited reporting of Suspected Unexpected Serious Adverse Reaction (SUSAR) notices to clinical research physicians / investigators. Timely notice reduces risk of additional adverse reactions including death, by speeding awareness of any reaction issues. Proof of timely e-delivery of these notices to investigators protects the sponsor (pharmaceutical, biotech, life science, medical device companies) and their contract research organizations (CRO), and all involved.
Regulations in the USA, Europe, Canada and other countries require reporting to the appropriate regulator within 15 days of awareness of the SUSAR. Proof of timely e-delivery of these reports to regulators is essential for an auditable proof record of compliance.
RMail Security Automation services provide simple ways to integrate sending encrypted Registered Email messages from existing business process systems like Pega, Oracle, SAP, Salesforce.com, and specialty CRO and CRM systems. This includes automated sending with security gateway and email routing policies, SMTP address re-routing, and high-speed REST APIs for sending and retrieving e-delivery evidence data.
Email encryption for HIPAA and GDPR privacy compliance automatically delivers email in a unique way to each recipient, creating the simplest user experience for the recipient while returning auditable proof of privacy and compliance to the sender– going far beyond basic TLS and link-retrieval systems. RMail includes different levels of encryption for when it is important to keep messages private from the recipient’s email administrator or email systems like Gmail, and others who may otherwise have access to their email.
RMail transmission encryption is most popular among health care professionals when communicating referrals, lab results or other private patient information. RMail message-level encryption is most popular when communicating patient information that is very sensitive.
RSign® electronic signatures are the simplest to use, most affordable full featured web-based electronic signature service. RSign makes it easy for signers to complete and sign documents using any desktop or mobile web browser in an intuitive, guided signing process.
RSign is the easiest way to obtain patient information filled into forms sent by email or posted on websites, with the completed form compiled as a PDF record and with options to automatically back-fill form data into the health care information management system.
Amgen enhanced its electronic clinical research system with RMail secure electronic messaging.
Amgen, an American multinational biopharmaceutical company headquartered in California, integrated RMail so that certain physician packages could be transmitted via Registered Email™ services with encryption when needed; importantly returning proof of delivery of disclosures to reduce risk. With RMail’s easy-to-use, cost-effective and award-winning Registered Email™ service, Amgen was able to transmit essential documentation with returned delivery evidence, thereby complying with requirements.
Amgen is one of the world’s largest life sciences companies with specialty in biotechnology. We’ve been providing assurance that critical medical disclosure packages are reaching researchers and physicians, to reduce risk of a missed critical communication; and to provide auditable, timestamped proof of content successful delivery.
Registered Email™ services provide proof of delivery compliance for Suspected Unexpected Serious Adverse Reaction (SUSAR) notices to clinical research physicians / investigators. Regulations in the USA, Europe, Canada and other countries require reporting to the appropriate regulator within 15 days of awareness of the SUSAR.
RMail® email encryption provides simple to use and automated privacy compliance for HIPAA, GDPR, and other state and country regulations protecting personal private information, returning auditable proof of privacy compliance in the form of a Registered Receipt™ email record for each message sent.