Adverse Event Management and Reporting Services

More than 2,000,000 cases managed with positive impact on product safety

SafetyCall’s highly trained professional staff provides a variety of services to our clients to support them in the areas of adverse event management, post-market surveillance, product stewardship, and customer service.

We provide timely and complete adverse event regulatory reports involving regulated products. We can also implement trend analysis and benchmarking reviews. We have medically trained staff who can triage as well as provide product safety information to consumers.

If clients wish to have all consumer contacts supported, we also offer customer resource services in addition to adverse event and product safety services.

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.

Data Collection

SafetyCall uses its own, proprietary electronic data collection tool, SafetyNotes™, to document interactions with callers. SafetyNotes™ is 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 collection
  • Product use circumstance information, including a description of incident scenarios in appropriate context
  • Route of exposure
  • Patient management site (e.g. home, workplace, health care facility)
  • Clinical signs and symptoms
  • Severity assessment may be added as an additional service
  • Consistency assessment and scoring may be added as an additional service
  • CRC codes (consumer inquiry codes) may be configured to meet Client needs

Data Access

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:

  • View case detail reports
  • Search case data by selecting various criteria
  • Download case data into a comma delimited file
  • View attachments to cases such as consumer emails or image files of letters

Record Retention

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.

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.

SafetyCall will respond to any incoming report of an adverse event by providing individuals or their medical providers with provisional medical assessments and advice 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™ data collection database.

Services to our clients will include triage to appropriate medical professionals for further medical intervention in those cases likely requiring such intervention. The Adverse Event Call Center services are staffed with SafetyCall 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 written communications.

SafetyCall will provide medical information services, including incident management, first aid and medical treatment advice for basic on-site patient management, general medical and clinical toxicology consultation for health care providers, and health and safety information to the Client’s customers, medical personnel, and others, regarding the Client’s products.

These services include an individualized medical triage where appropriate and incident documentation. SafetyCall will respond to any inquiries it receives on behalf of the client.

SafetyCall is able to respond to inquiries requesting medical and/or toxicology information related to product use but that do not involve an adverse event. Responses to these inquiries are intended to assist the caller in avoiding or preventing adverse clinical effects, promote safe use of the product, and reduce incident related claims.

Notification

SafetyCall will maintain a standard guideline for Client notification of potentially serious or significant cases of interest.

Access to Safety Data

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.

SafetySearch allows clients to search their adverse events by a multitude of criteria including product name, UPC/NDC/EPA registration number, patient demographics, symptoms, and outcomes over any date range. These search results are then formatted into various outputs which include single Case Detail Reports (a “snap shot” of what occurred on a specific adverse event) that can be quickly printed or saved as .pdfs to be passed on for internal review as well as comma separated value files of the various data fields collected which our clients commonly use to import into their own databases. For clients with FDA regulated products, cases that require submission of a MedWatch From 3500A can be searched for and the attached form can be printed off for review.

Also included as part of our baseline package of reports is our Route/Severity report which looks at various products, active ingredients or SKUs and the severity of the adverse events involving these with respect to the route by which the patient was exposed.

If you have products regulated under TSCA, SafetySearch can be used to produce a report listing all of your potential TSCA(c) and 8(e) cases in the event of an audit by the EPA.

Customized reports can also be developed to meet client needs.

SafetyCall’s SafetyNotesTM documentation system is designed to facilitate the documentation and management of all Adverse Event Reports. Our health care specialists are trained to obtain all the required case information in preparation for the submission of the report to the appropriate regulatory body where a mandatory reporting requirement exists. We are experts in regulatory requirements and can help companies understand their compliance obligations. Whether it is the FDA, EPA or Health Canada, SafetyCall understands regulatory responsibility.

Human

SafetyCall’s SafetyNotesTM documentation system is designed to facilitate the documentation and management of all Adverse Event Reports. Our health care specialists are trained to obtain all the required case information in preparation for the submission of the report to the appropriate regulatory body where a mandatory reporting requirement exists. We are experts in regulatory requirements and can help companies understand their compliance obligations. Whether it is the FDA, EPA or Health Canada, SafetyCall understands regulatory responsibility.

USA


FIFRA 6(a)(2) Regulatory Reporting

Companies with products possessing EPA Registration numbers are subject to mandatory reporting requirements for incidents involving these products pursuant to Federal Insecticide Fungicide and Rodenticide Act (FIFRA) section 6(a)(2). Additionally, EPA registered products with like formulations sold in other countries require that foreign incidents involving these formulations also be reported to the EPA in compliance with FIFRA section 6(a)(2).

SafetyCall FIFRA 6(a)(2) Surveillance Key Services

Completion of a Case Severity Assessment consistent with EPA guidelines on each symptomatic case associated with a pesticide registered with the EPA.

SafetyCall will provide monthly single incident reports and quarterly aggregate reports to the Client for cases of alleged adverse events involving EPA registered products. Adverse events involving EPA registered products will be documented and coded using EPA guidelines
Adverse events resulting in death will be delivered to the Client within 5 business days for review and submission to EPA as a mandatory 15-day single incident report.

TSCA Regulatory Reporting – USA & Canada

Under the Toxic Substances Control Act (TSCA) Section 8(c), companies are required to record, retain and in some cases report “allegations of significant adverse reactions” to any chemical substance or mixture that they produce, import, process, or distribute and that is not subject to mandatory surveillance compelled by other regulations such as Federal Insecticide Fungicide and Rodenticide Act (FIFRA) 6(a)(2) or the regulations of other agencies such as the FDA.

Furthermore, under TSCA Section 8(e), any person who manufactures, imports, processes or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment, must inform the EPA of the information unless the person knows that the EPA is already aware of the risk. Such information is commonly referred to as “substantial risk information.”

SafetyCall TSCA 8(c) & 8(e) surveillance services shall consist of the following operations:

  • All adverse incident reports are reviewed on a periodic basis, to ensure complete and accurate documentation consistent with the rules outlined in TSCA section 8(c) – 40 §CFR part 717. SafetyCall applies a severity assessment on symptomatic cases and provides a consistency assessment on those cases having a severity of Minor (with patient seen in the ER), Moderate, Major or Death.
  • SafetyCall will identify and flag potential TSCA 8(c) reportable cases that involve “unexpected (as per the label, MSDS or literature) significant adverse reactions.”
  • Those incidents resulting in substantial injury as defined by a severity assessment of Major or Death will be independently reviewed for TSCA section 8(e) reportability in order to identify chemical substances or mixtures that present a substantial risk of injury to health or the environment and it is determined that the EPA is not already aware of the risk.

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Manufacturers of dietary supplements and/or over-the-counter (OTC) medications must comply with the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469) for adverse events (AEs) associated with the FDA regardless of whether a causal relationship has been established between the manufacturer’s product and the adverse event.

SafetyCall Dietary Supplement Adverse Event surveillance services consist of the following operations:

Documentation of individual adverse event reports based on the core safety data contained within the FDA Form 3500A.
Each new AE report (or update made to an existing AE report) will be reviewed by a Senior Clinical Toxicologist/Pharmacist within 1 business day to determine if the report involved a serious outcome in accordance with FDA criteria.
Each AE report will be flagged as either ‘non-serious’ or ‘serious’.
AE reports that are flagged as ‘serious’ will be classified as 15-day alert reports and require that an individual FDA Form 3500A be completed by a SafetyCall pharmacist and forwarded to the client for submission to the FDA.

NDA/ANDAs

Manufacturers of a new drug application (NDA) or an abbreviated new drug application (ANDA) must comply with 21CFR310.80 and 21CFR310.98 for adverse events involving their products.

SafetyCall NDA/ANDA Adverse Event surveillance services consist of the following operations:

  • Documentation of individual adverse event reports based on the core safety data contained within the FDA Form 3500A.
  • Each new AE report or update made to an existing AE report will be reviewed by a Senior Clinical Toxicologist/Pharmacist to determine if the report involved a serious unexpected (unlabeled) adverse effect.
  • Reports flagged with serious unexpected AEs will be classified as 15-day alert reports and require that an individual FDA Form 3500A be completed by a SafetyCall pharmacist. The Form 3500A will be delivered to the Client for review and final sign-off before delivery to the FDA.
  • Reports involving serious expected (labeled) AEs or non-serious AEs will be flagged as Non-expedited AE reports. An FDA Form 3500A for each Non-expedited AE report shall be completed and delivered to the Client prior to the anniversary date of the NDA/ANDA for inclusion in the Periodic Adverse Drug Experience Report (PADER).

At the Client’s request, SafetyCall may assist in the preparation of the PADER.

Medical Devices

Manufacturers of medical devices must compl with the Medical Device Reporting (MDR) regulations (21 CFR 803) for adverse events involving their products.

SafetyCall MDR surveillance services consist of the following operations:

  • Documentation of individual MDR reportable events based on the core safety data contained within the FDA Form 3500A.
  • Each new MDR report or update made to an existing MDR report will be reviewed by a Senior Clinical Toxicologist/Pharmacist to determine if the report involved a serious injury or a malfunction that could have resulted in serious injury as defined in 21CFR803. Each MDR report will be flagged as either a ‘Serious’ or a ‘Non-serious’ MDR report.
  • AE reports that are flagged as ‘Serious’ will be classified as Expedited 30-day alert reports and require that an individual FDA Form 3500A be completed by a SafetyCall pharmacist and forwarded to the client for submission to the FDA.

CPSC Adverse Event Database Service

The Consumer Product Safety Commission (CPSC) Consumer Product Incident Database was established to serve as a government funded, publicly searchable forum for allegations by consumers of injury or believed risk for injury related to the use of consumer products or substances regulated by the CPSC. If a consumer reports to the CPSC a product related adverse event that satisfies the minimum required information for publication, the Commission will transmit the report to the manufacturer, or private labeler, within 5 days of receipt by the Commission. Once received, the manufacturer will then have 10 days to provide a written response that will be published along with the consumer report in the database.

SafetyCall Key Service Elements

Establishing an on-going system of surveillance for CPSC incidents which includes:

 

  • Receiving, documenting and tagging those consumer incidents that are forwarded to your company by the CPSC.
  • Identifying “materially inaccurate” incident data and verifying the claim is eligible for publication.
  • Provision of a Senior Toxicologist review and drafting of an articulate, professional response for submission consideration by the manufacturer in response to the consumer’s report.

 

Canada


Manufacturers of drugs and natural health products in Canada must comply with the Food and Drugs Regulations and the Natural Health Products (NHP) Regulations.

SafetyCall NHP/Drug adverse reaction surveillance services for Canada shall consist of the following operations:

  • Documentation of individual adverse reaction (AR) reports based on the core safety data contained within the Health Canada Mandatory Adverse Reaction Reporting Form for Industry for NHPs or the CIOMIS I for drug products.
  • Each new AR report or update made to an existing AR report will be reviewed by a Sr. Clinical Toxicologist/Pharmacist to determine if the report involved a serious outcome.
  • AR reports that are flagged as ‘serious’ will be classified as Expedited 15-day alert reports and require that an individual Mandatory Adverse Reaction Reporting Form for Industry be completed for NHPs or a CIOMS I completed for drugs. The appropriate form will be delivered to the Client for submission to Health Canada.
  • At the Client’s request, SafetyCall may assist in the preparation of the Annual Summary Report for each licensed NHP or drug.

Canada PMRA

Clients with active ingredients and/or pesticides registered with the Canadian Pest Management Regulatory Agency (PMRA) are subject to mandatory reporting requirements pursuant to the Pest Control Products Incident Reporting Regulations. These regulations require the submission of electronic PMRA Incident Reporting Forms within prescribed timelines based on the severity classification of individual Canadian incidents.

Additionally, all formulations sold by a Canadian company’s affiliated or subsidiary company in the USA that contain active ingredients that are registered with the PMRA, must have certain US incidents associated with these active ingredients also reported to PMRA.

Finally, for each active ingredient associated with 10 or more incidents over a prescribed 12 month period, the registrant must provide an annual summary report identifying the total number of incidents reported and providing a concise critical analysis of the data.

SafetyCall PMRA Surveillance Key Services

  • Completion of a Case Severity Assessment on each symptomatic case associated with a pesticide registered with the PMRA.
  • Incident reports must be electronically submitted to the PMRA within 15 days, 30 days, 3 months or 12 months depending on the severity of a given incident as well as the species involved. SafetyCall will complete the appropriate PMRA designated electronic Incident Report Forms for delivery to and review by the Client well in advance of the deadline for submission to the PMRA by the Client.
  • At the request of the Client, SafetyCall consulting services may be used to assist in the preparation of the Annual Reports required for each active ingredient associated with 10 or more incidents over the prescribed 12 month period.
  • In addition to the mandatory data fields, PMRA Incident Reporting Form contains an optional field for the provision of supplemental qualifying information. For those incidents of significance having a severity of moderate, major or death, SafetyCall may also be used to provide a toxicological assessment as to the clinical relevancy of the incident and its biological plausibility.

Canadian Consumer Product Safety Commission Services

The Canadian Consumer Product Safety Act (CCPSA) is a recently enacted law that applies to a wide variety of consumer products including children’s toys, household products, sporting goods and specialty chemicals. The Act requires industry to provide information to Health Canada concerning consumer product safety incidents or product defects that result, or could reasonably be expected to result, in death or serious harmful health effects. This “early warning” provision also applies to inadequate labeling or instructions that could lead to the same results, and to recall orders or other corrective measures initiated in other jurisdictions for human health or safety reasons. It is important to note that serious incidents occurring outside of Canada may also fall under this new regulation if the consumer product involved is also sold in Canada.

SafetyCall CCPSA Surveillance Key Service Elements

  • Independent review by a Senior Clinical Toxicologist of all adverse events for potential CCPSA reportability.
  • Expedited completion of severity/consistency assessments of all symptomatic human cases.
  • Immediate delivery of mandatory 2-Day alert reports on the appropriate regulatory forms for Client submission to Health Canada.
  • Assistance with the preparation of the mandatory 10-day Follow-up report.

Animal

SafetyCall’s SafetyNotesTM documentation system is designed to facilitate the documentation and management of all Adverse Event Reports. Our veterinarians and certified veterinary technicians are trained to obtain all the required case information in preparation for submission of the report to the appropriate regulatory body where a mandatory reporting requirement exists. We are experts in regulatory requirements and can help companies understand their compliance obligations. Whether it is the FDA, EPA or Health Canada, SafetyCall understands regulatory responsibility.


FIFRA 6(a)(2) Regulatory Reporting

Companies with products possessing EPA Registration numbers are subject to mandatory reporting requirements for incidents involving these products pursuant to Federal Insecticide Fungicide and Rodenticide Act (FIFRA) section 6(a)(2). Additionally, EPA registered products with like formulations sold in other countries require that foreign incidents involving these formulations also be reported to the EPA in compliance with FIFRA section 6(a)(2).

SafetyCall FIFRA 6(a)(2) Surveillance Key Services

    • Completion of a Case Severity Assessment on each symptomatic case associated with a pesticide registered with the EPA.

SafetyCall will provide single incident and quarterly aggregate reports to the Client for cases of alleged adverse events involving

  • EPA registered products. Adverse events involving EPA registered products will be documented and coded using EPA guidelines
  • Adverse events resulting in death will be delivered to the Client within 5 business days for review and submission to EPA.

 

TSCA Regulatory Reporting – USA & Canada

Under Toxic Substances Control Act (TSCA) Section 8(c), companies are required to record, retain and in some cases report “allegations of significant adverse reactions” to any substance or mixture that they produce, import, process, or distribute and that is not subject to mandatory surveillance compelled by other regulations such as Federal Insecticide Fungicide and Rodenticide Act (FIFRA) 6(a)(2) or the regulations of other agencies such as the FDA.

EPA’s TSCA Section 8(c) rule requires producers, importers, and certain processors of chemical substances and mixtures to keep records concerning significant adverse reaction allegations and report those records to the EPA upon notice in the Federal Register or upon notice by letter from the EPA. The TSCA Section 8(c) rule also provides a mechanism to identify previously unknown chemical hazards in that it may reveal patterns of adverse effects which otherwise may not be otherwise noticed or detected. An allegation made by an employee must be kept by the company for 30 years by the company while all other allegations (e.g., those made by plant site neighbors or customers) must be kept by the company for 5 years. Further information is available under 40 CFR Part 717.

SafetyCall TSCA 8c surveillance services shall consist of the following operations

  • All adverse incident reports are reviewed on a periodic basis, to insure complete and accurate documentation consistent with the rules outlined in TSCA section 8(c) – 40 §CFR part 717., SafetyCall applies a severity assessment of Minor, Moderate, Major, or death on symptomatic cases, and provides a consistency assessment (marked as Consistent, Inconsistent, or Indeterminable) on those cases having a severity of Minor (with patient seen in the ER), Moderate, Major or Death.
  • SafetyCall will identify and flag potential TSCA 8(c) reportable cases that involve “unexpected (as per the label, MSDS or literature) significant adverse reactions.”

Under TSCA Section 8(e), any person who manufactures, processes or distributes a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to human health or the environment shall immediately inform the EPA of such information unless such person has actual knowledge that the EPA has been adequately informed of such information.

Information does not need to be reported under Section 8(e) if the information:

  • Has been published in the open scientific literature
  • Has been previously reported to the EPA under mandatory reporting
  • Corroborates (in terms of dose, species, route, exposure time, nature of observed effects) information already known to the EPA
  • Standard TSCA 8c surveillance will be completed as described previously
  • Cases that are determined as either Inconsistent or Indeterminable. If a case is marked as consistent, it will then be reviewed by a Senior Clinical Toxicologist to determine if it falls under Section 8(e) reporting requirements. A search in SafetyNotes™ using the Potential TSCA 8e cases report will be conducted monthly to find these cases.
  • If a case may be reportable under 8(e), the case will be tagged in the SafetyCall Client database as Potentially 8(e) reportable
  • The SafetyCall Client Liaison will notify the Client that the case has been classified as Potentially 8(e) reportable and will forward them a copy of the case detail report.

FDA Regulatory Reporting

In addition to the adverse event management for veterinary pharmaceutical products, SafetyCall International can assist animal drug manufacturers/marketing authorization holders (MAH) remain compliant with FDA regulations via our veterinary adverse event reporting services.

Under section 21 CFR 514.80(b) of the FDA’s regulations, applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) are required to report adverse drugs events and product and manufacturing defects in a timely manner. This continuous monitoring is the primary means by which FDA’s Center for Veterinary Medicine (CVM) obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product/manufacturing problems.

SafetyCall’s team of experienced veterinary professionals operates our veterinary adverse event service and can help to ensure FDA compliance by:

  • Identifying and tracking all cases in need of mandatory reporting (3-day, 15-day, periodic)
  • Establishing due diligence by providing timely and thorough case follow with all necessary reporters (pet owners, veterinarians, etc.)
  • Completing reports via the Safety Reporting Portal or revised Form 1932 in a timely and medically professional manner. Once the reports are complete, the MAH will be notified so that they may then review and submit the reports.
  • Providing clinical expertise to assist the MAH in determining causality assessments.
  • Periodic Drug Experience Reports (PDER) can also be completed at the client’s request.
The United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA APHIS) regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective.

SafetyCall International does not offer any USDA reporting services for animal products. We do, however, manage any adverse events related to vaccines.

Canada PMRA

Clients with active ingredients and/or pesticides registered with the Canadian Pest Management Regulatory Agency (PMRA) are subject to mandatory reporting requirements pursuant to the Pest Control Products Incident Reporting Regulations. These regulations require the submission of electronic PMRA Incident Reporting Forms within prescribed timelines based on the severity classification of individual Canadian incidents.

Additionally, all formulations sold by a Canadian company’s affiliated or subsidiary company in the USA that contain active inigredients that are registered with the PMRA must have certain US incidents associated with these active ingredients also reported to the PMRA.

Finally, for each active ingredient associated with 10 or more incidents over a prescribed 12 month period, the registrant must provide an annual summary report indentifying the total number of incidents reported and providing a concise critical analysis of the data.

SafetyCall PMRA Surveillance Key Services

  • Completion of a Case Severity Assessment on each symptomatic case associated with a pesticide registered with the PMRA.
  • Incident reports must be electronically submitted to the PMRA with 15 days, 30 days, 3 months or 12 months depending on the severity of a given incident as well as the species involved. SafetyCall will complete the appropriate PMRA designated electronic Incident Report Forms for delivery and review by the Client well in advance of the deadline for submission to the PMRA by the Client.
  • At the request of the Client, SafetyCall consulting services may be used to assist in the preparation of the Annual Reports required for each active ingredient associated with 10 or more incidents over the prescribed 12 month period.
  • In addition to the mandatory data fields, PMRA Incident Reporting Form contains an optional field for the provision of supplemental qualifying information. For those incidents of significance having a severity of moderate, major or death, SafetyCall may also be used to provide a toxicological assessment as to the clinical relevancy of the incident and its biological plausibility.

Aggregate Data Interpretation and Trend Analysis

SafetyCall clinicians routinely help clients understand their on-going safety surveillance experience by analyzing the aggregate AE data. Coupled with individual case assessments and applying best practice trending approaches, SafetyCall data analysis allows:

  • Review of normalized to sales incidence rates for all AE allegations of injury broken down by age and outcome;
  • Tracking of expected incidence rates to determine an acceptable range for likely events and identify unexplained variations to that range in any given time period;
  • Identifying incidents that may signal a safety issue as well as those reported events that are more likely to be representative of background noise;
  • Identifying likely causes or contributing factors for suspected sentinel events or for deviations from expected incidence rates;
  • Assessment of the level of concern for any identified adverse effects and an evaluation of the likely adverse health impact to consumers using the product.

Benchmarking within and across product lines and categories

Every product has its own safety profile and SafetyCall helps its clients establish and understand the safety profile for their individual products. Since every company needs to assess and benchmark the safety profile of their product(s), it usually requires that they compare their products against other products in their market and determining how their product stacks up with the competition or even against other products within the company’s existing line of products. SafetyCall experts have more than 30 years’ experience in doing just that by applying their extensive expertise which spans every consumer product category. SafetyCall uses its broad market safety experience to help companies understand their own product, its overall safety profile, how it compares to other products in the market sector and how the product risk/benefit equation can be accurately presented to manage or mitigate risk, maximize benefit and enhance the product life cycle.

Case Consistency Assessments and Scoring

Most companies that document their adverse event experience have systems in place to collect and tabulate information provided by consumers and others regarding adverse events potentially involving the use of a company’s product. Although putting in place a basic documentation system may help companies meet the letter of the law, best practice companies understand the need to fully understand their adverse event experience so they can confirm that their products are meeting their intended purpose without unintended consequences. This requires a stepwise process of documenting, tabulating, analyzing and, when required, reporting of adverse events to regulators or even insurers. There are a number of things that distinguish the post-market surveillance services of SafetyCall from the basic call intake and documentation procedures that are typical of most customer service complaint handling services. SafetyCall service offerings in this area are designed to help companies meet each step of a total solution best practice surveillance system including:

  1. Individual Case Assessments
  2. Aggregate Data Interpretation and Trend Analysis
  3. Benchmarking within and across product lines and categories
As your Consumer Care Center, SafetyCall can assist in managing all consumer related inquires by telephone, letter and email communication. Our representatives provide quality service and effectively recognize the caller’s needs, assist the consumer and provide resolution to their inquiry. Being fully trained in each industry we service, our representatives ensure all reportable calls are directed to the correct department to meet industry specific regulatory requirements.

All communications are entered into a single database, SafetyNotes™, for consistent tracking and are easily accessible to our clients using our proprietary SafetySearch™ software. We provide you with detailed and customizable reports of all consumer inquires to fit your needs. SafetyCall can track and fulfill consumer product reimbursement and replacement requests. We can also track and retrieve products from consumers by mail when product retrieval is necessary for quality or manufacturing investigations.

SafetyCall Consulting Group

The SafetyCall consulting group leverages the overall adverse event experience of experts within the firm and helps our clients address and manage a variety of post-market surveillance and product safety related needs. Specialists are available to help in almost every product lifecycle stage from concept to in-market support.

Human and Veterinary Experts and Expertise

Composed of medical and toxicology specialists that are academically affiliated and nationally/internationally recognized experts in their fields, SafetyCall senior clinicians can help any company manage and address any product related safety issue they may face. SafetyCall also maintains a network of external specialists that can be called upon in unique circumstances.

Credentialed Experts:

  • Pharmacists
  • Veterinarians
  • Physicians
  • Professionals in the basic sciences

Human Medicine and Science

    • Clinical/Medical Toxicology
    • Pharmacology
    • Forensic Toxicology and Expert Witness
    • Occupational Dermatology
    • Ophthalmology
    • OB/GYN
    • Internal Medicine
    • Critical Care
    • Emergency Medicine
    • Occupational Medicine
    • Epidemiology
    • Product Safety

Veterinary Medicine and Science

      • Small animal clinical and applied toxicology
      • Small animal emergency and critical care medicine
      • Small animal internal medicine
      • Large animal clinical and applied toxicology
      • Large animal internal medicine
      • Clinical pharmacology
      • Public health

Core Consulting Services

      • Product Research and Development
        • Ingredient safety reviews
        • Formulation reviews
        • Pre-Market hazard assessments
      • Manufacturing and GMP’s
        • Manufacturing breach safety impact assessments
        • Development of Health Hazard Evaluations (HHE’s)
        • Investigations involving product quality impacting consumer safety
      • Packaging & Labeling
        • First aid, cautionary warnings and safety labeling
        • Safety related package design advice
      • In-Market Support
        • Adverse event incident investigation
        • Issue management
        • Risk communication
        • Product related poisoning prevention, education and outreach
        • Product liability
          • Merit analysis for claims and/or allegations of product related Injury
          • Expert witness testimony

Post-Market Surveillance Specialty Services

      • Adverse event signal detection
      • Benchmarking and trending
      • Stewardship programs
      • Data analysis