SolarisRTC
Solutions
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). When clinical market entry is not the right path, we help you evaluate non-medical positioning and navigate compliance boundaries—ensuring clear, accurate communication that avoids unintended clinical claims.
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Learn About Our Solutions For Business Success
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. “When clinical market entry is not the right path, we help you evaluate non-medical positioning and navigate compliance boundaries—ensuring clear, accurate communication that avoids unintended clinical claims. Quality and safety are at the core of everything we do. Our foundation—Patient first. Quality always.—means we are committed to both the effectiveness and safety of your solutions, with strategic foresight and execution excellence.”
Business Strategy
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 study plans. SolarisRTC acts as your broker, one-stop shop, or a tailored combination of both.—depending on your needs. We go beyond “you ask, we execute.” We think with you—not just for you—as a true partner. Built on Esther’s legacy of challenging the status quo, we think critically, creatively, and strategically to deliver solutions that anticipate needs, question assumptions, and drive meaningful progress. We support you in building trust with stakeholders by identifying key endpoints, validating AI algorithms, novel diagnostics, or integrating digital pathology endpoints. We help you align scientific rigor with your objectives, for either business or health care providers by helping understanding the specific regulatory needs and demonstrating high-quality outcomes. Our network and in-house capabilities enable us to deliver flexible solutions—from custom EDC development, clinical trial operations, and statistical analysis to report writing and service partner coordination. This to help in optimizing the balance between costs, time and resources to making them aligned with your goals without compromising quality. Above all, we focus on efficiently and effectively implementing the ‘patient first’ and ‘do no harm’ principles in everything we do.
Reimbursement Strategy
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
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
Meet our team and explore how SolarisRTC can support your next milestone with integrity, clarity, and purpose.
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.
Implementation and Application
Patient first in everything we do and we recognize that in today’s healthcare environment, providers face rising pressure—from informed patients seeking a more active role, to complex regulations ensuring safety, privacy, and ethics. To help patients, we help the healthcare provider, who is under pressure, as patients get more knowledge through AI and want to become part of the ‘patient management team’. The heavily regulated provider’s environment is to ensure patient safety, data privacy, quality control, ethical standards and patient wellbeing.
How We Solve
Together with our trusted partners we have gained a deep understanding of lab medicine, latest science, biomarkers and experimental as well as effective treatment. We understand how to implement tests and treatments effectively and efficiently with impact, while ensuring patient wellbeing. Applying and Implementing this information early in the product development cycle and clinical utility, could enable your business to expedite the submission process for new drugs, medical devices, and therapies. And as users, it could enable that test results and related treatment will reach your patients more quickly optimizing patient management.
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.
