ICON Launches New Patient Safety Service for Real-time Analysis of Aggregated Safety Data
Latest ICONIK service enables more informed, data driven decisions regarding patient treatment and safety
ICON plc, (NASDAQ: ICLR) a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today launched ICONIK Patient Safety, the latest service to leverage its ICONIK technology platform.
Identifying potentially significant clinical issues in real-time, ICONIK Patient Safety offers a systematic way to monitor safety trends in accumulating data, spot potential safety issues and take appropriate corrective and preventative action while the study is on-going. Data can be queried dynamically at any level of detail (single patient, single site, across an entire study or entire compound), helping sponsors make informed, data driven decisions regarding patient treatment and safety, study direction and regulatory reporting. ICONIK Patient Safety eliminates the lengthy, manual review of individual patient files, allowing a faster and easier review of aggregated safety events across study populations.
Commenting on the new service, Dr. Peter Schueler, Senior Vice President Medical & Safety Services, ICON Clinical Research, said: “Patient wellbeing is paramount in any clinical trial. ICONIK Patient Safety allows real-time review of integrated patient safety data, thereby improving our ability to identify and monitor unexpected adverse events. ICONIK Patient Safety helps study teams maintain a view of a drug’s evolving safety profile by accumulating safety data in real-time and allowing for quick identification of emerging safety issues, affording greater protection of patients’ well-being. Before ICONIK Patient Safety, this level of dynamic analysis and management of patient safety was simply not possible.”
ICONIK Patient Safety is the latest service to leverage the ICONIK technology platform and follows ICON’s recent announcement of ICONIK Monitoring, a new service that improves quality and reduces the costs of clinical development through more effective use of monitoring resources.
The statements made in this press release may contain forward-looking statements that involve a number of risks and uncertainties. A description of risks and uncertainties relating to ICON and its business can be found in Forms 20-F for the fiscal year ended December 31st 2012 and in the other forms filed with the US Securities and Exchange Commission, including the F-1, S-8 and F-3. ICON disclaims any intent or obligation to update these forward-looking statements.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
