Clinical Trial Patient Safety & Management
Safer Trials. Stronger Data.
Ensuring patient safety throughout clinical trial planning and conduct is paramount.
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The accurate and timely capturing and reporting of serious adverse events is a critical component of a successful trial.
Proper safety reporting to sites, institutional review boards (IRBs), and regulatory authorities protects both patients and the integrity of the study results.
That requires ongoing safety analysis and vigilant attention, so every serious adverse event (SAEs) is reported in accordance with regulatory requirements.
At Veristat, we work with the sites, monitors, sponsors, and investigators to ensure proper and timely reporting of all safety issues, helping protect the safety of trial volunteers.
We know there are always unknown challenges when bringing a novel therapeutic to market, so we've assembled an extraordinary team of scientific-minded experts who have mastered the complexities of therapeutic development, enabling sponsors to succeed in extending and saving lives.
Veristat's Offerings
We work with the sites, monitors, sponsors, and investigators to ensure proper and timely reporting of all safety issues, helping protect the safety of trial volunteers. Here's what that work covers.
Clinical Trial Safety Planning
Safety Management Plan Development.
Safety Management Plan Development. Outlining safety management responsibilities between Veristat and the sponsor.
Pregnancy & Safety Guidelines.
Creating the guidelines and forms needed to ensure proper reporting of pregnancy and SAEs.
Safety Database Oversight.
Overseeing the build and maintenance of your safety database with our Data Management team.
Post-Marketing Pharmacovigilance
Risk Management Plan (RMP) Development.
Developing, negotiating, and implementing RMPs with regulatory agencies from marketing application through the product’s entire market lifecycle.
SAE Management During Clinical Trial Conduct
Documentation Triage.
Reviewing initial and follow-up source documentation for reportability, accuracy, and completeness.
Case Number Assignment.
Assigning case numbers to all new SAEs.
24-Hour Causality Assessment.
Obtaining the causality assessment from the medical monitor within 24 hours.
Site Communication.
Coordinating with sites to obtain supporting documentation, including discharge summaries, autopsy reports, and diagnostics.
Safety Narrative Drafting.
Drafting safety narratives per ICH guidance and querying sites for additional information as needed.
MedWatch/CIOMS Form Completion.
Completing the regulatory forms required for adverse event reporting.
Global SUSAR Submission.
Submitting Suspected Unexpected Serious Adverse Reactions (SUSARs) to regulatory agencies worldwide.
NEXT STEPS
What's Next in the Drug Development Process
Data Monitoring Committees.
Add independent safety oversight to protect patients and trial integrity.
Marketing Applications.
We help prepare, write and defend your marketing applications with the global regulatory agencies.
Pharmacovigilance.
Continue post-marketing safety monitoring for the full life of your product.
Safety Writing.
Turn your SAE data and safety narratives into the aggregate reports (DSURs, PSURs, PADERs) regulators require.
Know What Your Safety Data Means for What Comes Next
Every serious adverse event adds to the evolving safety picture of your trial. Veristat helps you capture, assess, and interpret that information so emerging risks become clearer, safety strategy stays informed, and your team has the direction it needs to make critical decisions throughout the study.
Frequently Asked Questions
Veristat obtains a causality assessment from the medical monitor within 24 hours of a new Serious Adverse Event being identified.