SolarisRTC is your partner in strategy and operational execution in Precision medicine, for drug development using digital tools including companion diagnostics as well as for development of companion diagnostics and diagnostics in digital health. From hardware to Software as a Medical Device (SaMD) / Medical Device Software (MDSW) including Machine Learning and Artificial Intelligence (ML/AI).
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Our business, regulatory, clinic, quality, biopharma, In Vitro Diagnostics (IVD) and healthcare industry expertise helps you succeed with the development and deployment of your products. Our value proposition is to create a more efficient, collaborative and secure end-to-end process. Our solutions are proven, strategic and created specifically to meet your business needs.
Clinical Strategy & Operations
A great business strategy provides a roadmap for success, enabling businesses and organizations to achieve their goals, gain a competitive advantage, optimize resource allocation, adapt to change, make efficient decisions, drive innovation, and align stakeholders. It serves as a vital tool for sustained profitability, growth, and long-term success in today’s dynamic digital health business landscape. Developing a successful business strategy for the digital health industry requires careful consideration of various factors, including market dynamics, industry trends, regulations and customer needs.
How We Solve
Optimizing business models by unraveling the maze of all involved stakeholders, each with their own specific goals, when bringing innovation and emerging products, specifically companion diagnostics to patients. We have a deep understanding of the change in the current health care setting, i.e., a shift to model of care delivery as well as user and patient engagement through platforms and need for personalized approach, and the growing wealth of data to enable precision medicine.
Our solution is, instead of the typical linear approach, to have a vision, a holistic view and systemic approach to work as a collective with a cohesive value story.
Regulatory Strategy and Operations
The healthcare industry is heavily regulated to ensure patient safety, data privacy, quality control, and ethical standards. A robust regulatory strategy with related operational execution and a deep understanding of regulations is a must to ensure alignment with regulatory requirements. Implementing this early in the product development cycle enables your business to expedite the submission process for new drugs, medical devices, and therapies. This facilitates innovation and enables patients to access novel treatments more quickly.
How We Solve
With our expert knowledge, gained over the years collaborating with competent authorities, we strive to use science to identify scalable paths for all your products and related product claims to prevent legacy. At the same time, these paths will be aligned with your business needs for both the short and long term, including making optimal use of availability to and accessibility of your current assets. We strive to take the lead in ideation and development phases by being compliant while challenging the status quo.
Clinical Strategy and Operations
Clinical strategy and operations facilitates a culture of continuous improvement. Embedding Good Clinical Practice (GCP) to ensure implementing and applying ethical principles, collecting reliable and accurate data to answer the key study objectives and drive compliance with regulations, while ensuring safety for the user and study subjects. Developing a successful clinical strategy, is a must for filings of your products to competent authorities.
How We Solve
Having been accountable for global registration studies, we tap into our knowledge and experience and share this to optimize your clinical study plans. We support you in building trust with stakeholders by identifying key endpoints, understanding the specific related digital pathology regulatory needs and demonstrating high-quality outcomes. This to help in optimizing the balance between costs, time and resources to making them aligned with your company goals. We do this by identifying and reducing bottlenecks, and improving overall efficiency. We focus on efficiently and effectively implement “patient first’ and ‘do no harm’ principle in what we do.
Developing a well-designed reimbursement strategy holds immense significance in driving the success of your company or organization. By advancing reimbursement processes, you can improve revenue streams and establish long-term financial sustainability. Incorporating best practices and efficient procedures within a reimbursement strategy improves overall operational efficiency.
How We Solve
Working with you on your business plan, business model and products, we can identify evidence needed for product claims that drive product value. We will explore the paths to collect data to be used as evidence for reimbursement and when is best timing to start collecting these.
Quality assurance and Quality engineering. It all comes down to preventing shortcomings and limitations in the design, development, manufacturing, deployment and use of a product. Optimizing your Quality Management System (QMS) can prevent waste and upgrade the value stream. Moreover, it serves to create continuously reproducible and safe products, safe to be used and safe to be applied for its purpose.
How We Solve
Having worked in different settings and for different industries for many years, we have been exposed to many different quality management systems. We understand the different needs for different companies, there is no one size fits all. In addition, the regulations and guidelines are constantly changing. Being affiliated to organizations which are driving to develop general principles for implementation in the design control process and beyond, we stay abreast of the latest developments. We will use our experience, expertise and our knowledge to your best interest and apply them to customize to your needs
Business Operations and Partnerships
The trends in digital health, including digital pathology, show the industry is growing, actually it is just taking off. Along with making acquisitions, increasing partnerships between the health tech vendors, collaborations between industry and health care providers, we recognize the health tech is investing to drive digital health adoption. Patient management is at the centre of this. There is a shift in the model of care delivery becoming more patient focused, with a personal approach and personalized treatment. Pharma, developing effective and safe drugs, is an important, if not the most important, stakeholder. The need to have accurate diagnostics goes hand in hand
How We Solve
With our large network in the biopharma industry, we can connect the right stakeholders at the right time. Through our collaborations we build a strong foundation and connect all crucial elements in digital health to deliver precision medicine to patients. By optimizing diagnostic decision making, precision medicine will become reality.
Take the First Step
We want to hear about your unique business needs.
Schedule time to learn how SolarisRTC can support you in achieving your mission and successes. We are excited to partner with companies growing their revenue, accelerating their product pipeline and expediting early market access to improve personal healthcare.