Comprehensive Safety Assessment
PharmaVigilant provides a twelve point approach to provide our Sponsors with the fastest, most comprehensive understanding of the safety profile of their compounds from the first study to NDA. Our approach enables our Sponsors to meet their regulatory requirements without buying an additional safety system.
- Automatic notification of SAEs - PharmaVigilant provides Sponsors and their safety teams with automatic email notification of serious adverse events. The date and time are documented within the audit trail. Notification includes information on the study and the patient. Sponsors and their safety teams are also notified when there is any change to the data on SAE forms.
- Common AE/SAE database - PharmaVigilant provides a common form for both adverse events and serious adverse events. This assures that the data in both databases is the same, saving time and resources required for reconciliation with other safety systems. Exports from the common database can be provided if the Sponsor has a separate safety system.
- Comprehensive integrated safety views are available with InSpire. PharmaVigilant imports lab, ECG results, and ePRO data to assure that the Sponsors and their safety teams have all the information they need to fully assess the safety of the compounds and to meet their regulatory reporting requirements.
- Immediate and comprehensive cross study data analysis delivers the data and context required for regulatory reporting and to fully evaluate the safety of compounds. These tools are provided to our Sponsors and their safety teams when they use InSpire for their trials. Reports can be available for up to the minute review at any time or can be scheduled to be delivered to the Medical Monitor on a regularly scheduled basis. Reports can also be provided that deliver the listing of new AEs or SAEs over a particular timeframe.
- Pre-populated MedWatch or CIOMS forms provide the fastest and most complete approach to meeting regulatory requirements. Data that have already been entered within the EDC are pre-populated on the MedWatch forms. This assures that the data are accurate and eliminates the need for reconciliation. These forms are generated in PDF for submission and distribution as needed to regulatory and IRBs. MedWatch or CIOMS forms can be regenerated when additional data are provided or data changes.
- Separate Pharmacovigilance role enables the safety team to query data within EDC assuring that the data are maintained in the common database and are available for regulatory and final study reports. In addition this enables the safety team to complete the additional portions of the MedWatch form with a full audit trail documenting who completed the data, including dates and time.
- Storage of SAE source documents- SAEs can be automatically stored within I-Vault and all source documents can be collected and maintained within I-Vault. Now Sponsors have one location for all safety documents that can be visible within a study, across studies and locations. Because PharmaVigilant's I-Vault has de-identification capability, all safety source documents maintain subject confidentiality.
- Safety Document Distribution and Documentation-IND Safety Reports, Periodic Safety Update Reports, and any other documents can be distributed to the sites. Because our systems are 21 CFR Part 11 compliant, all documents are stored with time date stamp to confirm that investigators have met their distribution requirements. Sponsors can add an e=signature confirmation to the distribution process, if they desire.
- Third party review and adjudication- PharmaVigilant provides the ability to have forms or fields visible only by defined roles. With the ability to store images and have labs imported, third party reviewer can see all the documentation needed, complete their review forms, and enter the data directly into our EDC system without it being visible to other users.
- Auto coding within InSpire includes development of a knowledge base that can be used within a study and across studies for a specific compound. This knowledge base enables the sponsor to have coded terms for the SAEs immediately accessible for the regulatory submissions. In addition, the knowledge base assures that the coding is consistent across the entire trial or program. PharmaVigilant can manage multiple versions of MedDRA or Who Drugs across trials.
- Patient profiles- PharmaVigilant can provide patient profiles with all the data for subjects in the trials. Because PharmaVigilant integrates labs and EDC data into the EDC, these profiles can include all critical data for subjects.
- Ad hoc queries of any data from any trial; across trials: When doing safety assessment, it is often critical to be able to query data across all trials within a program and across programs. PharmaVigilant provides an ad hoc query tool that enables Safety staff to run queries and get immediate and unlimited answers to any queries of the data. Ad hoc reports can also be set up to be regenerated at will to enable ongoing review of data from all studies. The reports can be stored as time-date stamped PDF or can be exported to Excel for graphing.