Regulatory Scientific and Health Solutions (R-S-S)

This installment of Supplier Spotlight® highlights Regulatory Scientific and Health Solutions (R-S-S), which supports the biopharma industry by offering scientific data solutions and consultancy centered around regulatory expertise. Check out the interview below and visit R-S-S.

What is your company’s mission?

Regulatory Scientific and Health Solutions (R-S-S) is a functional service provider to the biopharmaceutical industry. Our mission at R-S-S is to advance our client’s journey toward licensing and reimbursement of new treatments and medical devices.

We have over 50 years of experience across nearly every therapeutic area, including medical devices. Throughout our collaboration with clients, our approach to delivery has been centered around our commitment to the delivery of projects with innovation, expert input and deep regulatory combined with reimbursement insight. We are committed to offering transparent and cost-effective pricing of our services at the highest quality. Our teams consist of world-leading medical experts, former regulatory and reimbursement assessors, highly skilled statisticians, SAS & R programmers, health economists, clinical pharmacology experts and data managers. Find more details at: R-S-S.com.

Our clients and collaborators include members of the top 10 pharmaceutical companies, CROs and academic partners as well as a network of ever-growing technical experts.

What products and services do you offer?

R-S-S provides delivery of high-quality services and strategic consultancy that are robust to the fierce reviews of regulatory and health technology assessment (HTA) agencies scrutiny while maintaining objectivity and integrity. We also offer HEOR services, including cost-effectiveness modeling, systematic literature reviews, network meta-analyses, survival extrapolation, utility modeling and RWD/RWE. We have a depth of experience in market access and reimbursement and support clients with payer value dossiers, value messaging, global HTA submission advice and landscape assessments.

Find more details at Health Economics and Market Access

We also support clients with study design and clinical development, with extensive experience in Protocol and SAP development, PK/PD Modelling and SAS/R Programming. Our team of highly skilled statisticians and data managers support clients every step of the way. Our services also include medical writing, scientific advice, veterinary drug licensing support and strategic regulatory advice on a global scale.

Find more details at Regulatory Statistical and Programming Services

Our expertise ranges in multiple disease areas including oncology, neurosciences, dermatology, cardiovascular, rheumatology, respiratory, endocrinology and nephrology.

What problems do you solve?

Clients often want help in planning a trial for successful licensing or reimbursement. We help design the best optimal approach for both, including all other processes that are needed from trial design to market access deliverables.

Some examples of problems solved:

• We have developed a prognostic biomarker through machine learning for endpoint qualification, allowing our clients to use the marker for their trial.
• We have developed a comprehensive systematic literature review (SLR) using combined real world and trial data in an orphan drug indication.
• We have optimized trial designs for gene therapy trials in hematology for rare diseases.
• We have developed and submitted approaches for cost-effectiveness for two biosimilars for HTA submission.
• We have developed an early decision-making software to prioritize which subgroups should be considered in HTA submissions.
• We have offered sound regulatory and HTA advice (jointly) to answer conflicting questions from licensing and HTA agencies.
• We have validated multiple cost-effectiveness models and tested them for scrutiny against HTA evaluation.

What are the most innovative tools and technologies that you offer?

R-S-S is investing in developing cutting-edge data solutions. Some of the innovative tools we have developed include:

• Sample size software for trials to demonstrate cost-effectiveness (Sample size for cost-effectiveness).
• Our sample size software (DM-RSS) also computes sample sizes in a Bayesian context as well as frequentist.
• We have developed a SAS code for Survival extrapolation for cost-effectiveness.

What are your competitive advantages?

Our combined regulatory and HTA experience with former MHRA, FDA, EMA and NICE experts are available for the most up-to-date regulatory solutions advice. With 50+ years of combined experience in almost every therapeutic area, we offer best-in-class statistical expertise for efficient clinical trial design. We have experience in all phases of development, a global reach and offer fair and competitive pricing for quality services.

Who are your clients?

We work with top 10 biopharmaceutical companies as well as a global network of clients. These include:

• CROs
• Biopharmaceutical companies
• Biotech companies
• Academic institutions and start-ups
• Non-For-Profit organizations who need support.

What new products and services are you developing in 2023?

We have a team of specialist software developers working alongside our statisticians to develop our new software, DM-RSS. This tool will help calculate sample sizes in Bayesian and frequentist frameworks, for cost-effectiveness and calculate the probability of future cost-effectiveness based on interim data as well as help set pricing earlier. We intend to launch the tool to the public in Q4 2023. Find more details here: DM-RSS

Where are your offices located?

We have offices in the UK (Birmingham), Switzerland (Zurich), Netherlands (Amsterdam) and the USA (Princeton, New Jersey).

To learn more visit https://www.r-s-s.com/ or contact them at enquiries@r-s-s.com