We’re proud to announce the launch of our new website and unveil our new logo, with a refreshed visual identity and digital space that better reflects who we are, what we do, and how we support our clients across the life sciences sector.

Our new design represents clarity, precision, and forward thinking bringing a more modern, confident look which symbolises our commitment to innovation, collaboration, and delivering high-quality, data-driven solutions for our clients now and into the future.

When we set out to redesign our website, our goal was simple: make it clearer, more intuitive, and more useful for our clients and partners.

We’ve streamlined the structure so you can easily explore our full range of services. Whether you’re a biotech start-up navigating early development or an established pharmaceutical organisation seeking specialist support, we want you to find exactly what you need, quickly and confidently.

The new website features:

• Clearer navigation across our service areas
• More detailed insights into our biometrics expertise
• A refreshed look and feel that reflects our professionalism and innovation
• Easier ways to get in touch with our team

We’ve taken care to ensure our website clearly communicates the depth and breadth of our capabilities. From study design and statistical analysis to high-quality data management and programming, we provide integrated solutions tailored to each client’s needs. The updated site gives you a more transparent view of how we collaborate, how we solve problems, and how we deliver results.

This relaunch marks an important step forward for us. As we continue to grow and evolve, we wanted our online presence to truly represent our expertise, our values, and our commitment to delivering high-quality biometrics services. We invite you to explore the new S-cubed Biometrics website and discover how we can support your next clinical development milestone.

Unexplained delays, questionable data, communication breakdown or operational slips could make you question whether your current biometrics CRO provision is delivering. Once a sponsor has lost trust in their current provider, it may be time to consider a specialist trial rescue biometrics CRO.

Changing your CRO mid-trial is not an easy decision, but it can be the most effective way to protect your study. Maybe you’re experiencing

• Missed timelines
• Lack of transparency
• Audit concerns
• Data quality issues
• Paperwork over teamwork

Those setbacks can be turned around with the right CRO partner. A company with proven expertise in rescuing studies, a flexible and rapid approach, excellent communication skills and a focus on accountability.

Rescuing a study starts with a full and unbiased appraisal of the current status. The transfer process needs to be handled carefully and quickly to maintain trial stability whilst prioritising realignment of trial goals. At S-cubed Biometrics, we have undertaken this process numerous times. We work professionally with your existing CRO and vendors to ensure a smooth transition.

If this sounds familiar, reach out to our team who will listen to your concerns, help you mitigate risks and achieve long term success.

Data integrity is paramount to great patient care, and this starts with trust in your biometrics team.

Real-world data (RWD) are data relating to patient health status and/or the delivery of health care collected from a variety of sources, while Real-world evidence (RWE) is the evidence produced from the analysis of this RWD. RWD typically consists of routinely collected data such as electronic medical records, medical claims data and disease and patient registries but can also include data such as patient reported outcomes (PROs) and data collected from wearable devices.

RWD is regularly analysed in post-marketing and safety surveillance studies to offer valuable insights into how treatments perform and are used in routine clinical practice, outside the confines of a randomised clinical trial. It is also increasingly being used to support the evaluation of treatments and devices as part of the approval process. The FDA, EMA and MHRA have all published guidance on the use of RWD and RWE in supporting regulatory decisions, though their definitions do differ slightly, the basic premise is the same, they are open to the use of RWD to support submissions with the caveat that the data used is relevant and reliable.

The use of RWD offers an opportunity to explore a variety of elements such as treatment adherence and use of concomitant medications in practice, to populations and sub-groups in which the efficacy is better or worse, to occurrence of rare and long-term outcomes and the identification of groups for which there are safety concerns.

While there are advantages of using real-world data to support drug development there are also many challenges that need to be considered both in the design and analysis of RWE studies.

Data collected in real-world settings is rarely perfect, with significantly higher levels of missing data and often quality issues that cannot be rectified in the same way as may be possible within a clinical trial setting. Therefore care needs to be taken to ensure that all potential data issues are accounted for in a way that demonstrates that the data used are reliable. In retrospective studies this will mainly be focused on implementing rules to ensure the data used for any analysis is correct and consistent. It can also be of interest to include sensitivity analyses to examine the outcome under different sets of assumptions.

In prospective studies it is important to design the study and data collection tools so as to reduce the potential for issues with data quality and completeness. Consideration needs to be given to the key information that needs to be collected in the study to evaluate the outcome, how this will be collected and recorded and what can be done to reduce the possibility of errors in data collection.

Studies that aim to use an external control arm derived from RWD sources needs to carefully consider how they will select their controls to minimise any potential bias and how they will ensure that the information that will be collected in the treatment arm of the clinical trial is available for the control arm also.

The use of RWD has the potential to reduce costs and time associated with drug development and can help to answer questions that are difficult to examine within a clinical trial setting but the value of their use will depend heavily on how they are used. If you’d like advice on how to design and analyse your real-world data studies get in touch with our team today.