Large Biopharmaceutical Companies

 


Large biopharmaceutical companies frequently undergo rapid growth and global expansion through mergers & acquisitions. Safety functions are large, frequently regionally or functionally disjointed, and are driven by compliance rather than enterprise-value. Companies in this segment often outsource parts of their safety functions to CROs and BPOs in order to reduce operating expenditure.

In such an environment, a breakdown of processes and communication, outdated technology, or oversight issues with service providers can easily create quality and compliance issues, but also – and perhaps more importantly – lead to increasing costs, and high operational and commercial risks.

InterVigilance services for large biopharmaceutical companies typically include safety management strategy development and risk analysis, safety operations design, implementation and management, vendor selection and management, as well as crisis management services. InterVigilance also supports the due diligence process for Drug Safety during mergers and acquisitions.
 

 

Small and Mid-Sized Pharmaceutical Companies


Small and midsize biopharmaceutical companies typically work with various third party organizations and vendors across Drug Safety and Pharmacovigilance. In-house safety teams are often limited by size and resources. The organizational setup often follows traditional concepts rather than principles of strategic value-adding safety management. Due to the size of their portfolio, individual product safety issues, if not managed strategically and proactively, can become high-risk for commercial success.

InterVigilance provides for clients in this segment organizational and strategic risk assessments, development and implementation of safety strategy, crisis management, vendor selection and management, coaching and training for executives and managers in safety management, organizational optimizations, safety technology selection, and advisory services for international expansion and partnerships.
 

Start-Ups

 

Biopharmaceutical start-ups are focused on the development and marketing of their products. Every adversity affecting portfolios or clinical trials have the potential to substantially affect enterprise success. Start-ups often work with a multitude of service providers and consultants across the different safety activities. Ineffective management and oversight of these relationships could pose serious risks to portfolio success.

In order to contain safety risks, start-ups depend materially on the development, implementation and operation of modern value-adding safety strategies, beyond the mere management of quality and compliance. For those clients, InterVigilance provides tailored start-up packages, which include safety strategy development, vendor selection and management, safety organizational design, management and risk assessments. We also provide executive advisory services which help entrepreneurs and executive leadership of start-up companies to develop their own approach to effective and value-adding safety management.
 

CROs & BPOs

 


Outsourcing Drug Safety and Pharmacovigilance services is at all-time highs. At the same time, fierce competition on price requires service providers to invest in differentiating service strategies which are attractive to their customers, but also enable them to credibly operate globally in drug safety, and grow market share. The demand for outsourcing in safety is rapidly moving away from case processing to more integrated (process/technology) value-adding knowledge-based services. Often services providers need help navigating this changing demand situation in order to achieve growth and commercial success.

InterVigilance offers reviews and design of commercial safety services strategies, go-to-market strategies, and portfolio expansion strategies helping service providers to take growth and competition beyond price and labor arbitrage, and enabling them to meet and exceed their customers' expectations. We also offer strategic planning and operational management services to help CROs & BPOs deliver on their safety projects.
 


Outsourcing Drug Safety and Pharmacovigilance services is at all-time highs. At the same time, fierce competition on price requires service providers to invest in differentiating service strategies which are attractive to their customers, but also enable them to credibly operate globally in drug safety, and grow market share. The demand for outsourcing in safety is rapidly moving away from case processing to more integrated (process/technology) value-adding knowledge-based services. Often services providers need help navigating this changing demand situation in order to achieve growth and commercial success.

InterVigilance offers reviews and design of commercial safety services strategies, go-to-market strategies, and portfolio expansion strategies helping service providers to take growth and competition beyond price and labor arbitrage, and enabling them to meet and exceed their customers' expectations. We also offer strategic planning and operational management services to help CROs & BPOs deliver on their safety projects.
 

Executives and Drug Safety Leaders

Executives and Drug Safety Leaders

 


Heads and managers of safety departments, and biopharmaceutical executives, often experience situations where Drug Safety and Pharmacovigilance issues reveal strategic, organizational, operational, technological and managerial challenges, potentially threatening scientific and commercial success. Expansion into overseas markets, multi-vendor setups and the ever changing regulatory environment in safety add additional complexity when it comes to planning, building and managing effective Drug Safety organizations.

Only leaders who have – besides medical-scientific and regulatory competencies – the resources and capabilities to proactively design and operate safety organizations with their processes, vendors, technology, human capital and stakeholders, will be effective and successful in the long run.

Based on our client's individual situation, InterVigilance provides tailored support programs ranging from coaching and interim management to formal training and development programs, in which we work hand-in-hand with safety leaders and company executives to facilitate fast-track safety strategy development, implementation and effective operational management of safety functions.
 

Drug Safety Consulting Firms

 

InterVigilance currently has partnership capacities for firms operating in the field of scientific or regulatory drug safety consulting, providing international strategic safety management consulting services to ensure successful implementation and effective operation of your safety plans. Contact us for further detail.

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