Introduction
As the pharmaceutical and technological landscape constantly evolves, staying agile and compliant is more crucial than ever. For small to mid-size pharma companies, this often means walking a tightrope between the need for efficient solutions and budget constraints.
The Challenges
Small and mid-size pharma departments face a unique set of challenges: they operate with a considerably smaller workforce and budget despite being held to the same regulatory and pharmacovigilance standards as larger and sometimes more mature companies. Due to these constraints, they often outsource parts of their drug safety operations, creating additional burdens around managing vendor relationships and business partner agreements. Additionally, while small and mid-sized companies often seek to expand their reach by adding new products and expanding to new regions, this can add additional complexity in managing local markets, new risk minimization requirements, and other such complexities.
Outsourcing operations, developing new products, and expanding into new regions all contribute to greater operational complexities with more requirements to follow, and more agreements to track and manage. This includes adhering to global Aggregate Safety Reporting Schedules and Risk Management Plan (RMP) tracking, as well as managing product-specific risk minimization requirements. While software solutions offer a pathway to efficiency in managing these demands, the cost of such technology can be prohibitively high for smaller firms, making it challenging for them to leverage these tools. As these smaller departments and companies strive to remain competitive, Orbit is answering the need for a “right-sized” Pay-Per-User licensing model that is a more accessible option.
A New Pricing Model with You in Mind
Orbit addresses the budget constraints of small pharma by offering a software solution with a new pricing model designed for small and medium-sized Drug Safety departments. In addition to Orbit’s original Enterprise pricing model, we have added a new Per User pricing model. Per User offers smaller companies a simpler, more affordable way to increase work efficiency, demonstrate compliance, and automate their work. Due to the unique challenges of small and mid-size pharma, a validated system capable of assigning tasks, tracking progress, managing customized workflows, and offering instant audit trails is essential for maintaining competitiveness and ensuring regulatory compliance.
Compliance Without the Complexity
Staying compliant with regulations while managing complex and siloed operations is a daunting task for every pharmaceutical company. With compliance features, such as:
- Tracking RMPs and supporting aRMM implementation,
- Managing the entire lifecycle of signal activities,
- Streamlining the exchange of safety documents with partners and affiliates,
- Managing aggregate safety report schedules, generation, contributions, and status across all products, and so on.
Orbit streamlines users’ work by offering automated and configurable notifications along with simplified reporting. The system features real-time dashboards and reports, which provide clear and comprehensive insights into all processes. A prime example of its utility is in the management of Pharmacovigilance Agreements and the tracking of service provider activities. Traditionally, the coordination between partners and agreements has been a manual and ad hoc process. Orbit transforms this coordination by automatically triggering notifications and outlining clear responsibilities and deadlines. This automation not only streamlines their workflow but also ensures compliance, maintaining a synchronized and efficient partnership environment.
Conclusion
Orbit’s Per User licensing model is a viable option for many small to mid-size companies navigating compliance and efficiency challenges. This model breaks down the barriers of high costs and complexity that often hinder smaller companies. Orbit’s tailored solutions are designed to grow with the company, adapting to changing needs and market dynamics. This approach goes beyond leveling the playing field between small and large pharma, empowering smaller companies to achieve greater efficiency and a competitive edge in the market.
Ready to take control of your licensing costs? Click here to explore Orbit’s licensing models and find the perfect licensing solution for you and your organization.
