Our Presence

USA | India

Email Us

info@atvigilx.com

Clinical safety Management

Clinical Safety Management at Atvigilx ensures comprehensive oversight of safety throughout the clinical development process. We prioritize patient safety and regulatory compliance at every stage.
Clinical safety Management

With decades of experience, we meet stringent pharmacovigilance regulations & certifications, ensuring that our clinical safety management processes set benchmarks for drug safety & patient protection.

Adverse Event Monitoring and Surveillance

Adverse Event Monitoring and Surveillance is a critical component of Clinical Safety Management at Atvigilx. Our dedicated team continuously monitors adverse events from clinical trials and post-marketing data to identify potential safety concerns promptly.

We employ advanced data analysis techniques and signal detection methodologies to detect patterns and trends that may indicate emerging risks. Our robust surveillance system ensures comprehensive data collection, rigorous assessment, and accurate documentation of adverse events.

We provide timely and detailed reports to regulatory authorities, ensuring compliance with global safety standards. Additionally, our proactive approach enables us to anticipate and mitigate risks effectively, contributing to enhanced patient safety and product quality.

Risk Assessment & Mitigation Strategies

Risk Assessment & Mitigation Strategies are essential for identifying, evaluating, & managing potential risks associated with clinical trials & marketed products. At Atvigilx, we ensure patient safety through

Comprehensive risk identification
Detailed risk evaluation & analysis
Implementing risk minimization measures
Continuous monitoring & reassessment
Development of Risk Management Plans

01Drug Safety & Reporting Training

Drug Safety and Reporting Training ensures staff are proficient in identifying, documenting, and reporting adverse events to maintain compliance.

02SAE & SUSAR Management

SAE and SUSAR Management ensures prompt identification, assessment, and reporting of serious adverse events to regulatory authorities.

03Safety Management Plan

Safety Management Plan outlines strategies for monitoring, assessing, and managing safety concerns throughout a product's lifecycle or clinical trial.

Safety Data Analysis & Signal Detection

Safety Data Analysis and Signal Detection is crucial in pharmacovigilance. At Atvigilx, our expert team employs advanced analytics to identify potential safety signals from vast datasets.

We conduct thorough analyses to detect trends, patterns, & emerging risks, ensuring timely intervention and regulatory compliance. With our proactive approach, we help safeguard patient well-being & optimize pharmacovigilance practices.

Data Collection
Gather safety data from various sources
Signal Detection
Utilize analytics for safety signal detection
Signal Evaluation
Prioritize signals based on importance for investigation
Safety Data Analysis and Signal Detection

"Safeguarding Patients, Ensuring Compliance:

Our Commitment to Clinical Safety

Management."