Prioritizing Patient Safety
At Worldwide Flex, ensuring patient health is the most significant objective in a clinical study. Drug safety and risk management are key contributors to safeguarding patients. Worldwide Flex’s medical and safety monitoring teams bring extensive experience and clinical expertise to your study, ensuring the necessary surveillance for medical and safety are in place.
Comprehensive safety services
At Worldwide Flex, we work with a variety of safety databases and visibility for risk mitigation and compliance. Medical monitors are board-certified physicians with training and specialties to provide rigorous medical oversight from study design through delivery.
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Serious adverse events
We expertly review and manage suspected serious adverse event (SAE) cases, prioritizing patient well-being. We engage in SAE receipt, individual case safety report (ICSR) processing, query management, and reconciliation.
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Streamlined approach
Worldwide Flex provides transparency with safety data. We offer electronic data capture (EDC) to safety database and E2B imports. Worldwide Flex works to eliminate redundant processes and documents.
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Data monitoring
Worldwide Flex offers data monitoring committee/data and safety monitoring board (DMC/DSMB), including management of adjudication and data safety monitoring committees.
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Safety expertise
Worldwide Flex builds are faster for our clients. We are recognized as experts in SAE migration and rescue opportunities.
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Adverse event coding
Adhering to MedDRA and WHO Drug standards, we meticulously code adverse events and medications. Additionally, Worldwide Flex prepares safety narratives.
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Aggregate reports
We excel in creating and submitting aggregate reports, including development safety update reports (DSURs), ensuring regulatory compliance.
Cutting-edge databases and processes
Worldwide Flex uses seamless collaboration tools to improve oversight and reduce risk. We engage modern safety applications to gain efficiencies and streamline case management. In addition, we use advanced cloud infrastructure to access and control data anywhere at any time.
We provide real-time access and oversight of adverse events and scalable solutions. Clients have access to supplemental staff. Worldwide Flex drives compliance with Good Clinical Practice (GCP) and procedures assuring you a trial’s patient safety and data integrity.
Expert physician support
Our medical monitors are board-certified physicians with expertise across indications. They provide invaluable patient safety support for medical oversight from study design through delivery.
Medical and safety monitoring
ensures vigilant oversight on assigned projects to safeguard patient safety.
Protocol and informed consent
contributions to study protocols, informed consent forms, and risk assessments.
Site support
includes addressing patient inclusion and patient exclusion criteria and safety concerns at investigational sites.
Comprehensive data reviews
of medical data, laboratory values, adverse events, and coding to identify trends and risks.
Transparency and safety
Our functional management team is accessible at every step to provide strategic oversight at any point of need. In addition, our governance and relationship management model ensures a transparent and proactive approach for risk identification and mitigation.
With Worldwide Flex, you can trust in our dedication to patient safety and our expertise in medical and safety monitoring. We’re your partners in ensuring the success and well-being of your clinical trials.
Pharmacovigilance services for clinical trials
Safety and efficacy expertise and offerings as part of Worldwide Flex’s flexible outsourcing models. We were the first contract research organization (CRO) to implement Veeva Vault Safety System.
Benefits
Seamless collaboration
Our tools facilitate efficient collaboration, improving oversight and reducing risks.
Modern safety applications
We employ the latest safety applications that enhance case management and streamline processes.
Advanced cloud infrastructure
Our advanced cloud infrastructure provides access to critical data at any time and from anywhere.
Scheduled updates
Stay current with regulatory requirements through our scheduled system updates.
Differentiators
Real-time access
Gain real-time access to adverse events, ensuring transparency and rapid response.
Scalable solutions
Our solutions are scalable, requiring minimal initial investment and no hidden upgrade costs.
Access to supplementary staff
Through Catalyst Flex, you have access to additional individuals or teams when needed.
Committed to Safety from Study Design Through to Delivery
Our Worldwide Flex medical and safety services are comprehensive to help set up and support your study success.