Services: Medical & Pharmacovigilance
To enhance regulatory compliance, a Cato Research Medical Monitor is assigned to every project and is accessible 24 hours a day, every day to handle critical situations.
The responsibilities of the monitoring physician include:
- Reporting serious adverse effects to the sponsor and to the FDA, according to Cato Research SOPs and FDA requirements
- Writing narrative descriptions of both significant and serious adverse effects for inclusion in the Final Study Reports
- Clarifying inclusion/exclusion criteria with the investigator
- Providing consultation for potential safety issues or medical concerns regarding the clinical study
Our medical team is supported by a dedicated pharmacovigilance group established to handle the processing of SAE reports to regulatory authorities and investigators. In addition to pre-marketed safety reporting, this group also provides post-marketing spontaneous adverse event reporting. Our personnel have the training, education, and experience to provide a comprehensive range of safety reporting services to meet the demands of SAE reporting requirements of global drug, biologic, and device clinical programs and post-market surveillance programs.
Cato Research has the flexibility to design unique processes for safety management; alternatively, sponsors may choose to follow Cato Research's SOPs that include use of Argus Safety and the medical coding dictionaries MedDRA and WHO Drug. Once the sponsor and Cato Research have agreed upon processes and templates, the pharmacovigilance group will create and document sponsor-specific work practices and forms.