At CliniRx, our Clinical Safety and Pharmacovigilance services speak to our commitment to always ensuring the safety and well-being of our clinical trial participants. Fully dedicated to regulatory compliance and patient-centric care, specifically, our team of experts meticulously monitors/evaluates each and every trial phase—reporting any adverse events to preserve the integrity of the ever-so-crucial drug-development process.
We also offer comprehensive safety solutions tailored to the unique needs of each clinical trial, leveraging cutting-edge technology and adhering to the most stringent industry standards with safety always top of mind.
Whether we’re engaging in proactive risk management or real-time safety assessments, we prioritize the detection of potential safety concerns meaning our clients can navigate the regulatory landscape with confidence and peace of mind.
Key clinical safety endeavors extend to:
Safety Monitoring and Reporting:
• We keep a close eye on safety data throughout every trial.
• We promptly report adverse/serious adverse events (AEs/SAEs) to regulatory authorities, ethics committees, and investigators.
Safety Data Collection/Analysis:
• We amass safety data from various sources via clinical visits, lab testing, and patient-reported outcomes.
• We incessantly analyze safety data to detect trends/patterns/potential safety signals.
Safety Database Management:
• We use the power of a centralized database to store, organize, and manage all safety-centric data.
• We work to ensure the highest levels of safety database accuracy, consistency, and integrity.
Safety Review Assessment:
• We hold safety review meetings on a regular basis to pore over cumulative safety data, discuss emerging safety concerns, and make informed decisions about trial continuation.
Regulatory Authority Safety Reporting:
• We prepare and submit periodic safety reports (e.g., Development Safety Update Reports - DSURs) to regulatory agencies to provide an overview of the trial's safety profile.
Safety Signal Detection and Evaluation:
• We proactively pinpoint potential safety signals via diverse surveillance methods.
• We thoroughly evaluate safety signals to determine their significance and potential impact on the investigational product benefit-risk profile.
Safety Management Plan Development:
• We create comprehensive safety management plans outlining related procedures for handling safety-related issues and detailing roles and responsibilities.
Data Monitoring Committee (DMC)/Safety Review Board Collaboration:
• We work with independent committees responsible for reviewing unblinded safety data and outlining recommendations regarding trial continuation, modification, and/or termination.
Experience supporting small Biopharma bring New Drug to Market!
We’ll be happy to discuss further.