Introduction
Pharmacovigilance (PV) is fundamental to the Pharmaceutical and Biotech industries. More now than ever, safety regulations are numerous and complex around the world. Regulatory authorities are requiring more safety documentation and review for product approvals and maintenance of the products license. Safety concerns have prompted global mandates for submitting significantly more product information. There is a growing volume of adverse events due to public awareness, social media and electronic links to numerous types of databases. All of these needs and requirements have put a tremendous burden on the industry to collect, analyze and report a much larger volume of adverse events, leading to increased costs to companies. The jobs to complete these unique pharmacovigilance activities also require an expertise which is difficult to recruit and is in a very competitive market place. In addition, there is a demand for vigorous compliance systems and experienced talent that has raised the cost of maintaining the infrastructure necessary to support the pharmacovigilance activities demanded by global regulators.
As a result, companies are turning to find strategic partnerships where they can outsource this function or at least aspects of this important function. The industry is continuing to look for ways to leverage outsourcing whether it is on-shore or an off-shore model or blended model.
Having an outsourcing option with an external partner provides many benefits such as the opportunity to reduce costs and leverage the domain and project experience of the partner who only focuses on pharmacovigilance. It can also offer greater flexibility, a simpler head count model, and a reduction in the organization overhead. Overall, depending on the size of the organization, its strategic development, available resources and growth perspective, many options are available for outsourcing pharmacovigilance activities.
How do you find the right partner for your company?
To be successful in selecting the right partner for your business, the client must identify their needs for outsourcing prior to initiating the selection process. Be sure your outsourcing strategy fits with the overall company’s strategy and ensure you have strong selection criteria in place. Deciding which activities to outsource is the next critical step for the outsourcer. Companies should start by identifying what should be considered as core competencies that they want to keep in house and the activities that could be outsourced to a partner. In the PV world, core competencies can be:
- specific expertise areas that cannot be easily delegated, such as deep knowledge of the product(s) safety profile, pre-clinical and clinical data
- critical activities that have a preeminent impact on business decisions, such as benefit-risk assessment, safety elements of the registration dossier, identification of the elements of risk evaluation and mitigation strategies
Each company should review key PV activities one-by-one and identify if each one is a specific asset that can or cannot be transferred out. When picking the right partner, the client needs to identify their business needs. Your strategy may depend on the product portfolio, stage in the product life cycle, therapeutic areas, and geography of the product sales. It might also depend on the products’ benefit risk profile.
Be sure to determine if your need is for domain knowledge, high volume, flexibility, cost, or business continuity, or a mixture of some of these items or all of these items. The client also needs to identify clear outcomes that they seek to achieve with this partnership. How much and what you want to outsource is also a question that your company needs to know prior to starting these conversations. In addition, know which products, processes, people, technology and geography are within the scope of your considerations.
Many companies are more comfortable outsourcing their mature products since the safety profile is more established. Some only want to outsource certain tasks or processes. Does keeping the activity in house represent a significant added value to the business and efficient use of the department resources?
For some companies establishing a pharmacovigilance system in house is not always cost effective and finding qualified and trained personnel is a major challenge. Some virtual and growing companies want to work with a PV partner to help them navigate through the complex and numerous pharmacovigilance regulations around the world and avoid the cost of many of the PV activities to help mitigate overall costs. By doing this, it allows the company to focus on the clinical development of the product. Be sure you have a scorecard to evaluate your partners and have the key stakeholders involved in this selection process.
What to Outsource?
Today the use of a partner for pharmacovigilance activities has become the new normal. Some of the key segments of pharmacovigilance actives that are commonly outsourced today include:
- Collecting, managing and reporting adverse drug reactions and events – A constant reconciliation process with the pharmacovigilance information and the medical information and product quality complaints is an absolute need.
- Triaging, causality assessment, medical narrative and coding and submission of individual case reports
- Literature review and evaluation – can be easily outsourced with significant benefits, focusing not only on individual cases but also with the identification of new information (e.g., pre-clinical, epidemiology)
- Aggregate reporting -the generation of data, listings and draft reports
- Signal detection and benefit-risk assessment – this is the most delicate responsibility to delegate. Because of the complexity and sensitivity of performing signal detection and benefit-risk assessment activities, and the unique nature of each product, outsourcing might not be the preferred option. A strategic partnership however, with a well-trusted expert company, could be considered if the company is not staffed for these activities. It is ultimately the responsibility of the sponsor to ensure that all signals are detected and the risks are minimized for the patients. Extreme care should be exercised when outsourcing.
- Review safety sections of protocol, Investigator Brochure – depending on the level and knowledge of internal safety experts, companies may choose to bring in external resources to help on these critical activities if there is not true internal PV expertise. Likewise, the reparation of a Safety Monitoring Plan for clinical trials requires a specific pharmacovigilance expertise that will benefit from an ad-hoc contribution from outside.
- Pharmacovigilance Database – acquiring, hosting and maintaining a PV database can be costly. There are interesting database options on the market allowing companies to avoid having to own and manage the system.
Other activities that are commonly outsourced include preparing standard operating procedures and other quality documents, assisting the company in preparing for inspections, collecting and preparing metrics to assist with compliance and quality, preparing or reviewing safety data exchange agreements with other business partners.
Things to Consider
As already stated, benefits of outsourcing include:
- Converting fixed resource cost into variable cost
- Reducing resources to recruit, manage and train personnel
- Reducing cost while increasing the efficiency of the process
- Provides a fully trained team of skilled professionals
- Provides flexibility to respond to varying workload, e.g., product launch
- Increasing business capacity management
Depending on an outside partner is still a concern for many companies, even today. Therefore, it is imperative that there are clear goals with meaningful metrics around productivity, quality, compliance and cost. It is important to think of your vendor as your partner and meet with them as much as you do with any employee to ensure goals are aligned and successful outcomes are achieved.
Many companies worry about the quality of the services when they outsource. Outsourcing does not and should not equate to poorer quality. The same metrics that are used in house to monitor performance and quality should be used with the partner.
Employee Considerations
It is imperative that employees understand the business rationale for outsourcing and the impact it has for them as individuals and the overall business. Be open and honest with all parties on what will be outsourced and what will not be outsourced. Be sure there are clear roles and responsibilities outlined for task and decisions.
Conclusion
Pharmacovigilance activities are viable candidates to consider for outsourcing because companies generally prefer to retain functions in house that provide a competitive advantage in the market place, including areas of significant intellectual property and brand impact.
To ensure a successful partnership, be sure you have a plan for how to manage and work with your partner. You need to identify key success metrics that are critical to track the quality and timeliness of the outsourced tasks which adds up to cost. In addition you should have regular performance and operations reviews and agreed escalation procedures. With proper governance, oversight, and a strong mitigation strategy in place these concerns can be addressed and resolved.
Having an open conversation with your potential partner will be important in your selection. Choosing a successful partner means finding a partner who fits with your company culture and a partner that you want to engage in a long term partnership as you will need to work together to navigate this difficult landscape.