Adverse Event Reporting
& Medical Information
For a variety of industries, SafetyCall provides 24/7/365 adverse event management, incident documentation, and first aid advice for basic on-site patient management, general medical and clinical toxicology consultation for health care providers, and health and safety information to our Client’s customers, medical personnel, and others, regarding our Client’s products.
SafetyCall handles telephone based as well as non-telephone based correspondence such as consumer email, customer service notifications, internet based inquiries, and written communications involving both human and animal product safety.
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:
- Provides all the functionality of a single global database required to manage adverse event reporting and adverse reaction requirements for multiple regions, including the US (FDA), Europe (EMA), Canada (Health Canada) and other countries following ICH Standards.
- ISO 9001 compliant
- Assured software validation for a hosted pharmacovigilance service (SaaS) that is underpinned by operational and management procedures written to comply with ISO 9001:2008.
- 21 CFR Part 11 compliant
- Fully integrated coding using MedDRA and VeDDRA.
- Provides a rich library of functions for electronic reporting (“e-reporting”) that ensure a comprehensive and efficient process for report generation, submission and receipt tracking. PV Works enables SafetyCall to generate ICSR files on behalf of its clients in the correct format for each regulatory authority for submission via the FDA Electronic Submissions Gateway, EVWeb system or other global e-reporting gateways (subject to formal validation with the recipient).
- Central to e-reporting is a database designed around the ICH E2b guidelines (for human pharmacovigilance) and the eudravigilance and FDA1932 regulation (for veterinary pharmacovigilance).
- Export or import XML files utilizing standardized e-reporting formats to and from regulatory authorities and partner companies.
- Creation of XML files in the HL7 based ICH E2b R3 format in anticipation of 2016 acceptance of this format.
- Fully scalable to power data analysis tools that monitor data for signals or trends to maintain pharmacovigilance and product compliance.
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:
- Caller and patient basic demographic information
- Product identification fields, including UPCs and identifying regulatory numbers
- Lot number
- Product use circumstance information, including a description of incident scenarios in appropriate context
- Route of exposure
- Clinical signs and symptoms
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.
With SafetySearch™, clients are able to:
- Search case data by selecting various criteria (e.g. – UPC/NDC/EPA, product name, patient demographics, symptoms, date ranges, or outcomes)
- Format search results into various outputs, including:
- Case Detail Reports, which provide a “snapshot” of what occurred during a specific adverse event
- Route/Severity reports, which examine various products, active ingredients, or SKUs regarding the severity of adverse events associated with these products in reference to the route by which the patient was exposed
- Reports listing all cases involving TSCA(c) and 8(e) regulated products in the event of an audit by the EPA
- Customized reports that can be developed to meet client needs
- Print a report of an adverse event or save it as a .pdf
- Search for and print MedWatch 3500A forms for FDA regulated products
- Download case data into a comma delimited file
- View attachments to cases such as consumer emails or image files of letters
SafetyCall clients utilizing PV-Works will have access to their electronica 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:
- Search case data by selecting various queries (e.g. – Date case created, product name, reportability status, lot number, date first valid, submission date, MedDRA terms, etc)
- Customize search results
- View attachments to cases such as consumer emails or image files of letters
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.
Facilitate Regulatory Reporting
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
Adverse Event Management
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.
Health & Safety Information Services
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 assuage 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:
- Fatality or life-threatening symptoms
- Product quality issues
- Suspicion of product tampering
- Threats of legal action or media coverage
- Alleged formulation problems
- Container or device malfunctions
- Requests for follow-up with a company representative
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.