With the development of new technologies and continuous investments in R&D, the pharmaceutical industry displays stable growth for the past years. However, industry growth also brings an increase in the amount of challenges and their complexity. Among them, we could single out two challenges that have the biggest impact:
- digital transformation.
Varying regulations across the globe, product innovation and new technologies heavily affect pharmaceutical companies who have to ensure that they are always aligned, transparent and modern.
One of the most affected functions inside pharmaceutical companies is pharmacovigilance.
Growing safety concerns that result in stricter safety regulations, growing amount of sources of safety signals, and growing demand for transparency put continuous pressure on the infrastructure. This in turn results in raising costs of its maintenance.
Specialised outsourcing in pharmacovigilance is one possible way of coping with the growing costs of keeping a highly qualified and trained pharmacovigilance team in-house. A well-implemented pharmacovigilance outsourcing program brings noticeable benefits including:
- Fixed costs become variable costs;
- Reduction of the number of resources to recruit, manage, and train;
- Increased flexibility;
- Improved efficiencies;
However, in order to harness maximum benefits from pharmacovigilance outsourcing companies need to ensure that they make the right decision about the scale of their outsourcing vendor relationship and ensure adequate oversight.
In this white paper, our pharmacovigilance professionals are sharing recommendations on how small, mid-sized and big pharmaceutical companies can organise their pharmacovigilance outsourcing in order to achieve the best results.
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Starting from July 2022, seQure is the business unit of Arithmos, related to Regulatory Compliance and Consulting Services.
Established in 2010, Arithmos helps pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and, through the seQure business unit, Regulatory Compliance and Consulting services.
Arithmos delivers solutions and services for:
- Pharmacovigilance & Safety
- Regulated Document Management
- Reporting & Analytics
- Quality Management
- Computer System Validation
- Regulatory Affairs
- Cloud Services
- IT Services
Arithmos’ industry-leading experts combine the knowledge of processes and technologies to implement a digital strategy, enable rapidly scale-up along with fulfilling oversight, governance, and compliance requirements.
Through a holistic approach, Arithmos supports Life Sciences companies with:
- Digital Transformation
- Business Process Re-engineering
- System Integration
- Data-Driven Management