Industries & Operations
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.
