ENTERPRISE SPONSOR: CRO
SanaClis, one of That's Nice's Road to 2021 sponsors, discusses how the company is evolving its partnership models or geographic footprint to meet the future of healthcare.
SanaClis meticulously reviews the evolving needs in clinical trials from the perspectives of both the patient and study sponsor. Being able to provide end-to-end clinical trials solutions and services enables SanaClis to become not just an outsourced contract research organization (CRO), but more of an active partner, ensuring the study achieves all of its objectives contained in the study protocol without undue delay, with all efforts concentrated on ensuring that the study reaches its next phase or market authorization. There are also several models SanaClis has adopted in order to reduce risks among the stakeholders of a clinical study, which is a unique approach to maintaining strong relationships with our study sponsors and ensuring that the study meets timelines and adheres to the budget.
Preferred Provider Relationship
SanaClis is proud to be a preferred provider to various top-10 pharmaceutical companies throughout Europe and the United States, both for clinical supply and functional CRO services. Owing to the experience, capabilities, and access to medical supplies that have otherwise been difficult to obtain — especially in the COVID-19 era — SanaClis has partnered with various European governments for the crucial supply of medicinal products and supplies.
SanaClis is a global CRO with integrated clinical supplies active in the majority of locations across the globe. Our unique selling proposition is our extensive experience and capabilities in Central and Eastern European (CEE) countries, where there are a plethora of advantages in the implementation of clinical studies, such as increased patient recruitment opportunities and high-quality data. Sharing this ability and experience allows our U.S. and Western European clients to take full advantage of the benefits of running studies spanning multiple locations, which positively impacts study budget and recruitment objectives. SanaClis is ready to assist our sponsors’ projects with our global platform while adhering to the budget.
Their primary goal going forward is competing for market share in terms of enhanced therapeutic area expertise, expanding on our full-service capability utilizing the latest technology, and increased functional capability. In the next decade, a hybrid model combining functional service provision (FSP) and full-service (FS) outsourcing will be key, and bilateral central control through a strong governance model and early planning and commitment will influence the success of projects.
Risk-based clinical trial planning has become ever more fundamental, which should increase preparedness for future pandemics.
Risk-based Planning
Risk-based clinical trial planning has become ever more fundamental, which should significantly increase preparedness for future pandemics. In the context of COVID-19, the introduction of our Patient Safety and Compliance Kits was revolutionary to the safety of both patients and site staff. SanaClis will continue to monitor the situation regarding the supply of this vital kit. Additionally, SanaClis believes a rigorous remodelling of all risk-based quality-management systems should be reviewed on a more frequent basis, incorporating and reflecting the current pandemic situation but with pre-emptive measures already accounted for. It is essential that the study design incorporates quality, as apposed to the approach of just solely monitoring quality in clinical trials.
