SSI Strategy has deep PV operational and scientific experience.

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Virtual Head of Safety

SSI Strategy is the pioneer for an offering we call the "Virtual Head of Safety". The service allows development and smaller pharmaceutical companies access to world class safety expertise in either a strategic or operational capacity, as their portfolio and budget dictate. Perfectly designed for companies that occasionally need a deeply engaged safety expert to treat the product as if an employee but not often enough to justify the high cost of a permanent head of safety. If you think this service might be a good fit for your organization, please call us to discuss further.

Scientific Support - Signal Detection, Analysis, and Decision Support

SSI Strategy can provide any type of scientific support that might be required for your organization.

Signal detection - we will review your data to identify potential signals
Signal Analysis - we can analyze the data on potential signals to determine any potential new safety issues
Once identified, we can work with you to identify and perform appropriate next steps

Safety Document Preparation - Benefit/Risk, Aggregate Reports, RMP, REMS

Safety Document preparation is core PV activity and SSI Strategy is prepared to assist your organization with any such needs:

Benefit Risk Analysis/Summary
Aggregate report writing - US Periodic, PSUR, etc.
Risk Management Plan (RMP) preparation
Risk Evaluation and Mitigation Strategy preparation and execution of any required activities

Clinical Trial and Registry Design and Execution

Postmarketing clinical trials and registries are key elements of the pharmacovigilance toolkit. SSI Strategy believes that trials and registries are critical for gaining better understanding of all potential safety issues as well as to gain other important information as mentioned.

As we believe registry data will benefit most or all products we have developed a relationship with a top tier, Ivy League medical school professor who will design and run any clinical registry very cost effectively. Benefits of registry data include:

Gaining better understanding of potential safety issues
Identifying potential safety issues in new or "real world" populations
Understanding background rates of important safety issues in specific populations

Pharmacovigilance Training

Safety Marketing Support is the term we use to describe activities related to promoting or controlling use of a product during marketed use. Safety Marketing Support refers to such activities as using safety data to differentiate products in the marketplace, influencing consumer behavior, and ensuring products are used by patients who will benefit most and incur the least risk.

Companies typically use the safety data they have generated/collected for a single reason, to meet regulatory obligations. SSI Strategy can help show your organization how to get the most out of your safety data. Read our blog series on use of postmarketing safety data to unlock additional commercial value from a portfolio while simultaneously decreasing risk.

In addition to using your safety data to its full value, SSI Strategy is able to assist you in controlling distribution of your products in the marketplace. Whether part of a REMS or other requirement, or simply good business practice, SSI Strategy can work with your team to put systems in place to ensure that your products are used properly.

Quality Management System, Metrics, Root Cause Analysis, Deviation Investigation

Quality Management System (QMS) refers to the overall system in place to ensure compliance within the PV System. All companies have a QMS although they might not be aware and certainly might not call it that.

Components of the quality management include an appropriate PV departmental compliance governance:

Training - described above
Documentation - Described below
Metrics - a robust set of metrics are necessary to ensure proper compliance monitoring
- On time expedited reporting
- On time aggregate reporting
- On time transmission of reports to license partners
- On time completion of external commitments
- On time completion of internal commitments
- Others as appropriate

Training - Development, Delivery, Documentation

SSI Strategy will work with your team to develop training content, design the system to ensure compliance with requirements, and to deliver it in an engaging and effective manner to ensure that both your PV organization and your entire company understand their responsibilities and work effectively.

SSI Strategy, realizing that PV must exist within a commercial world, can tailor sales force or other customer facing team PV training to leverage the safety process to strengthen relationships, instill trust in your company, and maintain patient safety

Specific training that SSI Strategy can deliver includes:

Basic regulatory training (including interacting with regulators)
Introduction to adverse events and safety information handling
Introduction to regulatory reporting to health authorities
Basics of signal detection
Interacting with healthcare professionals
Sales force training on safety information handling

Elements of the training management and documentation system that SSI Strategy can design along with your team include:

Determination of what training is necessary for a given role
Recording these requirements by role
Tracking progress toward meeting requirements
Flags for colleagues and managers when training is due or overdue
Developing training reports