Manage clinical trial safety with confidence
Clinical safety activities help protect study participants, support regulatory compliance, and maintain an accurate view of product risk throughout development.
Cencora supports sponsors from study start-up through final reporting with pharmacovigilance intelligence, Safety Management Plan preparation, case processing, safety writing, and regulatory submissions. You gain coordinated support for global trials, evolving local requirements, and time-sensitive safety operations.
Cencora supports sponsors from study start-up through final reporting with pharmacovigilance intelligence, Safety Management Plan preparation, case processing, safety writing, and regulatory submissions. You gain coordinated support for global trials, evolving local requirements, and time-sensitive safety operations.
Address clinical trial safety pressures early
Clinical trial safety work spans changing local requirements, rising data volumes, and strict reporting timelines. Cencora helps you manage these pressures with coordinated clinical safety support.
Navigate local requirements
Track evolving country-level and authority requirements so safety submissions, prerequisites, and cross-reporting activities stay aligned with local expectations.
Manage growing case volume
Process increasing volumes of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and related follow-up information without losing quality or timeliness.
Reduce reporting risk
Avoid delays, inconsistencies, and submission gaps that can affect inspections, regulatory compliance, participant protection, and study continuity.
Comprehensive clinical safety support
You receive tailored support across the clinical development lifecycle, from project setup through case processing, aggregate reporting, and submissions.
Cencora coordinates the procedures, tools, training, and intelligence needed to run compliant clinical safety operations across global studies and prepare for later lifecycle transitions.
Cencora coordinates the procedures, tools, training, and intelligence needed to run compliant clinical safety operations across global studies and prepare for later lifecycle transitions.
What we offer
Project oversight
Coordinate staffing, training, communication, timelines, and KPI strategy across sponsors, CROs” to “performance metrics across sponsors, contract research organizations (CROs).
PV intelligence
Monitor clinical safety requirements across countries and maintain structured intelligence on reporting rules, prerequisites, and submission pathways.
Study setup
Support database configuration, procedural documents, Safety Management Plans, study forms, and operational readiness for submissions.
Case processing
Handle SAE, SUSAR, pregnancy, and adverse event of special interest (AESI) intake, follow-up, data entry, coding, narratives, and reporting workflows.
Safety writing
Prepare development safety update reports (DSURs), Investigational New Drug (IND) annual safety reports, line listings, and other aggregate reports.
Safety submissions
Submit SUSARs, DSURs, and related deliverables to authorities, ethics committees, review boards, and investigators as required.
Why choose Cencora for clinical trial safety
Global safety reach
Coordinate intelligence, case processing, writing, and submissions across global studies with regional and local support structures.
Integrated safety support
Use one team for setup, ongoing safety activities, aggregate reports, and related authorization support when programs evolve.
Flexible team models
Scale support for new projects, ad hoc requests, and multi-study programs without rebuilding internal operating models.
Expert insight
Companies will need proper surveillance and an acute awareness of the evolving safety landscape to stay compliant with changing regulations.
— Monica Buchberger, Ph.D., and Stephen Sun, MD, MPH
Bringing a product to market in the EU: PV considerations for non-EU companies
Related solutions
Safety document reporting tool (psiXchange)
Automate the distribution, tracking and acknowledgement of safety documents for every recipient a study requires, in the format each one accepts.
PharmaLex is now Cencora
Clinical trial pharmacovigilance activities are part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about clinical trial pharmacovigilance activities?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.