Explore recent issues of Contract Pharma covering key industry trends.
Read the full digital version of our magazine online.
Stay informed! Subscribe to Contract Pharma for industry news and analysis.
Get the latest updates and breaking news from the pharmaceutical and biopharmaceutical industry.
Discover the newest partnerships and collaborations within the pharma sector.
Keep track of key executive moves and promotions in the pharma and biopharma industry.
Updates on the latest clinical trials and regulatory filings.
Stay informed with the latest financial reports and updates in the pharma industry.
Expert Q&A sessions addressing crucial topics in the pharmaceutical and biopharmaceutical world.
In-depth articles and features covering critical industry developments.
Access exclusive industry insights, interviews, and in-depth analysis.
Insights and analysis from industry experts on current pharma issues.
A one-on-one video interview between our editorial teams and industry leaders.
Listen to expert discussions and interviews in pharma and biopharma.
A detailed look at the leading US players in the global pharmaceutical and BioPharmaceutical industry.
Browse companies involved in pharmaceutical manufacturing and services.
Comprehensive company profiles featuring overviews, key statistics, services, and contact details.
A comprehensive glossary of terms used in the pharmaceutical and biopharmaceutical industry.
Watch in-depth videos featuring industry insights and developments.
Download in-depth eBooks covering various aspects of the pharma industry.
Access detailed whitepapers offering analysis on industry topics.
View and download brochures from companies in the pharmaceutical sector.
Explore content sponsored by industry leaders, providing valuable insights.
Stay updated with the latest press releases from pharma and biopharma companies.
Explore top companies showcasing innovative pharma solutions.
Meet the leaders driving innovation and collaboration.
Engage with sessions and panels on pharma’s key trends.
Hear from experts shaping the pharmaceutical industry.
Join online webinars discussing critical industry topics and trends.
A comprehensive calendar of key industry events around the globe.
Live coverage and updates from major pharma and biopharma shows.
Find advertising opportunities to reach your target audience with Contract Pharma.
Review the editorial standards and guidelines for content published on our site.
Understand how Contract Pharma handles your personal data.
View the terms and conditions for using the Contract Pharma website.
What are you searching for?
Developed on platform deploying rule-based automation for timely delivery of drug safety information
February 5, 2019
By: Tim Wright
Editor-in-Chief, Contract Pharma
ICON plc, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has released a new drug safety reporting solution based on an innovative cloud-based system, featuring automated and configurable business rules. The solution ensures compliance in an increasingly complex regulatory environment and enables the sponsor to gain visibility into the safety profile of an investigational product throughout its lifecycle. Using regulatory intelligence from 80 countries, the system is configured with date-stamped decision rules. This facilitates the required safety information to be submitted and distributed automatically to all relevant stakeholders including Investigator Sites, Ethic Committees, Institutional Review Board and Competent Authorities within due dates. Safety information is submitted in the mandated format in each case and a fully auditable distribution trail is provided. Overall, this leads to higher quality, increased speed and regulatory compliance. In addition, compound level reporting removes duplication of notifications to those sites participating in multiple studies investigating the same compound, thereby reducing investigator burden. The solution also features reporting functionality and a dashboard showing both individual and aggregate submissions at a study and portfolio level. This provides the sponsor with increased transparency to monitor and manage drug safety. “The regulatory landscape is continually evolving which makes drug safety reporting increasingly complex,” said Andy Garrett, executive vice president, scientific operations, ICON. “Combining our drug safety and regulatory expertise with innovative automation elevates ICON’s safety reporting by reducing the burden on investigator sites whilst showing clear benefits in terms of regulatory compliance.” The system used in delivering this enhanced service to sponsors is built on the Pega 7 cloud platform, a market leader in AI and business process management software. It can be deployed with any pharmacovigilance safety database, including the option to use as a stand-alone solution, avoiding additional sponsor technology expenditure.
Enter your account email.
A verification code was sent to your email, Enter the 6-digit code sent to your mail.
Didn't get the code? Check your spam folder or resend code
Set a new password for signing in and accessing your data.
Your Password has been Updated !