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Medical Safety

Prioritizing Patient Safety

At Catalyst Flex, ensuring patient health is the most significant objective in a clinical study. Drug safety and risk management are key contributors to safeguarding patients. Catalyst 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 Catalyst Flex, we work with a variety of safety databases, including ARISg and ARGUS, to ensure transparency and visibility for risk mitigation and compliance. We were proudly the first adopters of Veeva Vault Safety database, incorporating the cloud-based technology for all members of a project team, including yours. Medical monitors are board-certified physicians with training and specialties to provide rigorous medical oversight from study design through delivery. 

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.

Safety expertise

As the first adopter of Veeva Vault Safety System, Catalyst Flex builds are faster for our clients. We are recognized as experts in SAE migration and rescue opportunities.

Streamlined approach

Catalyst Flex provides transparency with safety data. We offer electronic data capture (EDC) to safety database and E2B imports. Catalyst Flex works to eliminate redundant processes and documents.

Adverse event coding

Adhering to MedDRA and WHO Drug standards, we meticulously code adverse events and medications. Additionally, Catalyst Flex prepares safety narratives.

Data monitoring

Catalyst Flex offers data monitoring committee/data and safety monitoring board (DMC/DSMB), including management of adjudication and data safety monitoring committees.

Aggregate reports

We excel in creating and submitting aggregate reports, including development safety update reports (DSURs), ensuring regulatory compliance.

Cutting-edge databases and processes

Catalyst 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. Catalyst 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 Catalyst 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.

Committed to Safety from Study Design Through to Delivery

Our Catalyst Flex medical and safety services are comprehensive to help set up and support your study success.