How EVIGATOR Empowers Pharmaceutical Companies to Navigate Complex Evidence Generation

In today’s complex pharmaceutical landscape, navigating regulatory and payor evidence requirements while maintaining robust research activities is no small feat. Senior Research Consultant Nils Picker, who has worked closely with pharmaceutical professionals throughout the planning process, shares why we built EVIGATOR and how it streamlines Evidence Generation Plans (EGPs), ensuring teams stay compliant, efficient, and aligned with evolving industry requirements.

As a research consultant deeply involved in the evidence generation processes, I've spent years helping pharmaceutical companies develop, assess, and refine their Evidence Generation Plans (EGPs). Recently, I had the privilege of contributing to the development of EVIGATOR’s planning framework—a software-based solution designed by GIPAM to streamline these critical tasks and transform how companies approach evidence generation. 

Who Can Benefit from EVIGATOR? 

EVIGATOR is designed for pharmaceutical companies, particularly those operating in multiple countries, where the need to coordinate global and local teams is crucial. It’s ideal for supporting cross-functional teams, including: 

• Clinical Research Teams: Streamlining the development and reassessment of study plans, ensuring alignment with both global and local needs. 

• Regulatory Affairs Teams: Ensuring that EGPs meet complex and evolving regulatory requirements across different markets. 

• Local Market Access Managers: Facilitating the creation of robust evidence that meets local/regional payor demands and supports successful market entry. 

• Global Product Managers: Overseeing the seamless implementation of EGPs, from planning to execution, with real-time collaboration across teams. 

The Need for a Streamlined, Collaborative Approach 

Pharmaceutical companies operate in a demanding environment where precision, compliance, and efficiency are paramount. Regulatory and payor requirements are becoming increasingly complex, often varying from one market to another. For multi-country organizations, this complexity is further compounded by the need to coordinate global and local teams, ensuring that everyone remains aligned despite the differences in regulatory landscapes and market needs. 

Through my work, I’ve seen firsthand how challenging it can be for companies to keep their EGPs up-to-date and aligned with these ever-changing requirements. This is where EVIGATOR comes in. By creating a structured and collaborative framework, EVIGATOR enables teams to efficiently develop new plans and reassess existing ones, ensuring that they meet both global standards and local requirements. 

EVIGATOR: A Collaborative Framework for Success 

EVIGATOR’s planning framework was developed with one primary goal in mind: to make the evidence generation process more efficient and collaborative. Having supported its development, I can confidently say that this platform is uniquely positioned to address the challenges faced by pharmaceutical companies today. 

1. Streamlined Planning for Global and Local Needs 

EVIGATOR’s structured approach to planning ensures that all aspects of an EGP—from initial design to final execution—are meticulously organized and easily accessible. This not only simplifies the planning process but also ensures that global and local teams are working from the same playbook, reducing the risk of misalignment or oversight. 

For companies operating across multiple countries, this is a game-changer. EVIGATOR allows teams to upload and share documents in real-time, facilitating seamless collaboration regardless of geographical location. This means that local teams can provide insights and updates that are immediately incorporated into the global strategy, ensuring that the EGP remains relevant and compliant with both local and global requirements. 

2. Efficient Reassessment and Refinement 

One of the key advantages of EVIGATOR is its ability to streamline the reassessment of existing EGPs. As regulatory and payor landscapes evolve, it’s crucial for pharmaceutical companies to regularly review and update their plans. EVIGATOR’s platform makes this process significantly more efficient by providing a clear, structured framework for reassessment. 

The platform’s pressure testing feature is particularly useful in this regard. By leveraging a structured questionnaire, EVIGATOR allows teams to identify potential gaps or weaknesses in their plans quickly. This not only facilitates faster decision-making but also ensures that the EGP is robust and ready to withstand scrutiny from regulators and payors. 

3. Collaborative Efficiency Across Teams 

In today’s interconnected world, collaboration is key to success. EVIGATOR was designed with this in mind, offering tools that enable cross-functional teams to work together seamlessly. Whether it’s uploading documents, sharing insights, or updating plans, EVIGATOR ensures that all team members have access to the latest information and are able to contribute effectively. 

This collaborative approach not only improves efficiency but also enhances the quality of the EGPs. By ensuring that all voices are heard and all perspectives are considered, EVIGATOR helps companies develop more comprehensive and effective plans. This is particularly important when navigating diverse regulatory environments, where local market access expertise is essential for ensuring compliance with health technology assessment (HTA) requirements. 

The Future of Evidence Generation with EVIGATOR 

As someone who has been deeply involved in the development of EVIGATOR’s planning framework, I am excited about the potential this platform offers to pharmaceutical companies. But the journey doesn’t stop here. The EVIGATOR team is continuously working on future updates to enhance the platform’s capabilities further. One of the most anticipated updates is the enhanced support for PICO (Population, Intervention, Comparator, Outcomes) assessments tailored for European HTA submissions. This functionality will provide even more granular guidance on aligning EGPs with the specific requirements of the Joint Clinical Assessments (JCA), helping pharmaceutical companies navigate this critical regulatory hurdle with greater ease and precision. 

With these enhancements, EVIGATOR will not only streamline your current processes but also future-proof your strategies, ensuring that your EGPs are always ready to meet the highest standards. For companies looking to navigate the complexities of regulatory, HTA, and payor requirements while maintaining their research activities, EVIGATOR provides the efficiency, precision, and collaborative capabilities needed to succeed. In a world where the demands on pharmaceutical companies are only increasing, having a platform like EVIGATOR at your disposal is invaluable. 

EVIGATOR is a game-changer in evidence generation. With its streamlined platform, you can create compliant, robust, and collaborative EGPs faster and more efficiently.

Discover how EVIGATOR can transform your evidence generation process and help you stay ahead in today’s competitive pharmaceutical landscape