SafetyCall will respond to any incoming report of an adverse event by providing individuals or their medical providers with provisional medical assessments and advice. Our team of toxicologists have developed treatment guidelines that are consistent with Standard of Care practices related to adverse event triage and case management. Each inquiry will be voice recorded and key pre-designated data elements will be documented in the SafetyNotes™ or PV-Works databases.
Services to our clients will include first aid advice for cases that can be safely managed on-site, and triage to appropriate medical facilities in those cases likely requiring such intervention. The Adverse Event Call Center services are staffed with licensed health care professionals and are available 24/7/365.
SafetyCall can also provide adverse event management and incident documentation for non-telephone based correspondence such as consumer email, customer service notifications, internet based inquiries and other written communications.
SafetyCall uses two similar but distinct software tools to document interactions with callers. SafetyNotes™ is our own proprietary electronic data collection tool, and is used for a variety of products such as pesticides, household goods, industrial chemicals, and personal care items. For pharmaceuticals, medical devices, and dietary supplements, PV-Works Pharmacovigilance Software System is used to meet all international regulatory requirements.
PV Works is a validated total pharmacovigilance software solution for the collection, management, assessment, and reporting of adverse events involving drugs, dietary supplements, medical devices and biologicals. PV Works operates on a secured Oracle database platform and has been used by multiple health care product companies globally to process over 2 million ICSRs for submission to regulatory authorities. The key features of PV Works are as follows:
The key features of PV247 are as follows:
Both SafetyNotes™ and PV-Works are designed to ensure that all appropriate data is collected for the purposes of monitoring a product’s post-market surveillance experience and for developing a product safety profile. This data set includes but is not limited to:
SafetyCall clients will have access to their electronic case data via the Internet using SafetySearch™, a secure password protected web-based search tool. SafetyCall clients may also use SafetySearch™ to download case data into a comma delimited file (.csv), a standard file format that may be imported to internal client information systems.
SafetyCall clients utilizing PV-Works will have access to their electronic case data via the Internet by logging directly into PV-Works. SafetyCall clients may also use PV-Works to download case data in an excel spreadsheet or individual case safety reports (ICSRs) in a .pdf.
With PV-Works, clients are able to:
With SafetySearch™, clients are able to:
Records of all adverse event experiences reported to SafetyCall and documented in SafetyNotes™shall be maintained for a period of no less than 30 years.
Record of all adverse event experiences reported to SafetyCall and documented in PV Works shall be maintained for a period of no less than 10 years.
SafetyCall can provide turn-key regulatory reporting to all relevant state and local agencies including EPA, FDA and CPSC. We also provide regulatory reporting to Health Canada and can guide you as to your regulatory obligations.
For SafetyCall clients utilizing PV-Works, SafetyCall is able to submit individual case safety reports, including 15-day alerts, as an XML in compliance with ICH e2b format directly to the FDA Gateway.
SafetyCall is able to respond to inquiries regarding the safety of products. Responses to these inquiries are intended to promote safe use of the products, reduce incident related claims, and assist the caller in preventing adverse clinical effects. We are also here to help mitigate any fears or anxieties consumers may have regarding normal product use.
SafetyCall will maintain a standard guideline for Client notification of potentially serious or significant cases of interest. Such cases may include but are not limited to:
Our SafetySearch web application is a powerful tool available to all clients for reviewing their case data via the internet in a secure environment. Application access is secured via IIS’s Windows Forms Authentication methodology which requires users to provide a login name and password to gain access. The application uses a public security server certificate to provide SSL encryption of data transferred from the user (client) to the server and vice versa. The public security certificate uses the RSA 1024 encryption level with SHA1 encryption algorithm.
