How is Intervigilance Different?
Trusted Expertise - Global Competence
At InterVigilance we believe that all biopharmaceutical companies need robust drug safety strategies and effective operations to be successful. We understand the pressure organizations are under when it comes to protecting patients, and at the same time their products and commercial goals, whilst continuously adapting to regulatory change, legal challenges, cost-pressures and new market requirements.
In such a complex and fast-changing environment across an intricate array of internal and external stakeholders and vendors, even small strategic or organizational weaknesses can have far reaching consequences, such as prolonged clinical trials, delayed product launches, restrictions in indications and labelling, or the need for multi-million dollar investments for additional safety studies or clinical trials.
Most challenges safety organizations face are either entirely avoidable, or can be mitigated before major damage is done through integrated strategies and operational excellence.
InterVigilance works with clients to reduce operational safety risks and create enterprise value by helping to develop and implement state-of-the-art safety management strategies.
But our support does not stop there! We understand that there is not one solution that fits all companies. But we also know that in many cases even minor changes to safety strategy and management applying tested principles will have immediate positive impact if executed effectively.
Our range of targeted and hands-on services will not only transform the way our clients approach safety management, but also focus on successful implementation and operational execution of those strategies to achieve business goals.
Strategic Safety Management
Some companies look at the way they manage their safety functions only when a crisis occurs: late reports, regulatory inspection findings, quality and compliance issues, high staff turnover, litigation, technology challenges, process breakdowns, delayed product launches, or issues with third party vendors and service providers. Not only damage has been done by this time, in most cases such situations would have been avoidable with the right safety management strategy.
Other companies might be biopharmaceutical start-ups thinking about setting up their first safety department, or enterprises planning global expansion, departmental growth, or attempting to reduce operating costs of their safety functions.
All these scenarios have one feature in common: they require modern safety management strategies to reduce risks, and achieve scientific and commercial success. Only flawless execution of such strategies by integrating human capital, systems, processes, stakeholders and vendors into an inclusive operating model will ensure success.
InterVigilance safety management services start with understanding your company's specific safety needs and commercial goals. In parallel, we analyze current challenges and risks, holistically and under the aspects of both risk mitigation and strategic planning.
Jointly with our clients' safety leadership and company executives we provide outlines of implementable strategic plans, which ultimately aim to correct current challenges whilst designing and implementing permanent safety management solutions.
The scope of this support is tailored to meet our clients' safety management needs, from standalone crisis management, to enterprise-wide global safety organizational planning and execution, vendor selection and management.
InterVigilance conducts risk assessment services for safety teams and departments for bio-pharmaceutical companies and life-science services providers. The scope of such assessments is based on clients' needs, and can range from single safety issue risk-assessments to enterprise-wide safety management risk assessments.
Typically, these assessments look across all relevant stakeholders into organizational, operational, process, technology and human capital risks, as they effect successful safety management.
Risk-assessment reports can be complemented by targeted or general corrective action planning, or be phased into a complete safety strategy management review, with aim to propose and implement changes to strategy and execution in order to reduce safety management risks.
Effective management of safety operations is a critical success-factor for the successful execution of enterprise-wide safety strategies. In today's rapidly changing regulatory environment, operational management capabilities for safety departments cannot remain limited to the medical-scientific and regulatory aspects of drug safety. Sound advanced management capabilities, ranging from financial, P&L and metrics management to change management, process improvements, systems management, technology and outsourcing vendor selection and management, cross-cultural and multi-functional people management, will determine organizational effectiveness and success.
The typical skill-sets required to run effective safety operations, depending on the setup and resources available to safety leadership and departments, very frequently exceeds that found in typical safety operations or safety services vendors.
InterVigilance helps their clients selecting the right talent for their safety operations, establishes management effectiveness, selects and manages vendors, provides operational transformation and improvement creating effective organizations, whether in one location, or across a multi-national setup covering safety operations needs in all ICH-regions and continents.
Operational management services also include in-depth operational reviews, support for reorganizations and restructuring (both strategy & implementation), as well as coaching for operations and management staff working in Drug Safety and Pharmacovigilance.
Most safety departments experience crisis situations from time to time. Common scenarios range from acute case volume increases, to process breakdowns, loss of key staff, technology and vendor issues, to regulatory inspection outcomes, legal and Public Health issues.
InterVigilance can provide the managerial know-how, oversight, leadership and strategic/tactical planning to lead and guide safety departments through these crisis situations.
Change Management and Reorganization Services
In today's rapidly changing safety and pharmaceutical environments, mergers & acquisitions, reorganizations and management of change are frequent occurrences. During such phases, safety operations need to maintain their functionality, whilst managing complex change. Such high-risk situations are often complicated by the break-down of processes, talent leaving organizations, communication and management oversight challenges.
InterVigilance helps clients with both the planning and the execution of these changes, covering the following areas:
Interim management support, change management, leadership & motivation, organizational design, contingency planning, leadership coaching, vendor selection and planning, due diligence reviews, cross-cultural management, and cross-organizational safety management.
InterVigilance focusses on the strategic management aspects of building and operating successful safety organizations. We are perfectly positioned to bring global strategic safety management competencies to traditional Drug Safety/Pharmacovigilance and regulatory consulting firms, complementing their service offering by combining the 'what to do' with the 'how to do'.
As the significance of effective Drug Safety and Pharmacovigilance functions for business success is rapidly increasing, leaders and managers of drug safety departments realize that their often medical-scientific and pharmaceutical backgrounds do only incompletely prepare them for the challenges of the job at hand.
Modern safety leaders have to rely more and more on their skills in general management, financial and P&L management, operational effectiveness, process improvements, cross-functional and cross-cultural management, vendor and technology management. The globalization of Drug Safety requires global organizational and managerial core-competencies beyond those normally found in a typical safety department.
InterVigilance provides executive support services which aim to work hands-on with leaders and manager in Drug Safety to help them managing their safety teams effectively. These services include, but are not limited to 1:1 coaching, skill assessments, key staff development, and group sessions in strategic safety management and safety management effectiveness.
Safety Vendor Commercial Strategy
With safety services outsourcing demand at all-time highs, the traditional CRO and BPO sectors undergo rapid change to secure and grow market share in the field of safety services. At the same time, new entrants to the drug safety services market seek to establish their footprints. Despite this trend, biopharmaceutical companies are increasingly concerned about increasing numbers of partnership failures with safety services vendors.
In order to meet rapidly changing customer needs, Drug Safety services providers need to develop differentiating strategies and core capabilities which not only help them to achieve their business goals, but also enables them to achieve high customer satisfaction for the services provided.
InterVigilance helps safety service providers of any size with the development of differentiating global service strategies, service footprints, implementation and go-to-market plans, enabling them to grow market share whilst increasing their base of highly satisfied customers.
Vendor Selection and Management
Outsourcing is a powerful tool for biopharmaceutical companies to manage their safety functions more efficiently. Indeed, today most safety departments already work with one or more vendors and consultants to achieve their financial, medical-scientific and regulatory goals. Due to the importance of high-quality safety functions for the safety of patients and the achievement of commercial goals, it is imperative that organizations identify the right vendor for their needs.
Finding the right vendor is often difficult, a prolonged and sometimes frustrating process. Not every vendor can provide the required level of quality, compliance, or Drug Safety competence required to ensure reliable and effective safety management. Navigating the ever growing market of service providers in Drug Safety and Pharmacovigilance becomes increasingly complex. More importantly, the management of these vendor relationships is often time and resource consuming, potentially reversing the benefits gained from outsourcing safety functions in the first place.
Biopharmaceutical companies have, however, a choice when it comes to vendor selection. InterVigilance provides clients with unique knowledge of the global safety services vendor market, helping to make the right choice. We can support your outsourcing strategy with the following services:
Outsourcing strategy development, ensuring that financial and scientific goals are met; RFI/RFP design; vendor assessment and selection; vendor due diligence audits: bid defense planning; pricing and KPI negotiations; vendor integration into safety processes; vendor relationship management.