SGS, a leading life sciences, clinical and bioanalytical contract solutions provider, today announced the launch of Simulo®, an in-silico modeling and simulation platform which facilitates complex clinical trial simulation to predict the expected results of prospective trials, while optimizing study design to increase the probability of a successful efficacy and safety outcome.
Simulo offers a modern software solution which implements pharmacokinetic (PK), pharmacodynamic (PD) and disease progression models, run in an accessible, user friendly, interface. This simulation tool has been developed to explore the time course of drug exposure, biomarker response and outcome – therapeutic and adverse – observed in clinical studies, in both the individual subject and at population level.
Two versions of Simulo are available. The “Standard” version of the software is free of charge and easy to use; operators have the option of learning its features by taking part in a one or two day training program. The Simulo “Expert” version comes with a scientific support package, to enable scientists to get all the benefits of collaborating with SGS Exprimo specialists when performing advanced clinical trial simulations.
“Simulation of clinical trial outcomes has always been cumbersome to conduct in a scientifically adequate way, requiring the writing of extensive computer programming code to account for the various levels of uncertainty. These include adaptive dosing schedules, heterogeneous study populations and patient dropout due to adverse events,” commented Daniel Röshammar, SGS Exprimo Scientific Director. “By sharing this software with our clients, we can help them to more easily reach the full potential of simulation techniques, resulting in more innovative and successful clinical trial designs, and may offer a strong research advantage.”
“As health authorities continue to recommend modeling and simulation tools, Simulo has the potential to revolutionize the field of clinical trial simulation, making the research and development process faster and safer,” added Jean-Luc Marsat, SGS Clinical Research Managing Director. “This service is a powerful tool that SGS can offer its clients to support their decision making processes, saving them time and money on their trials.”
SGS is a leading life sciences CRO providing clinical research and bioanalytical, biologics characterization, biosafety, and quality control testing. Delivering solutions in Europe and in the US, SGS offers clinical trial (Phase I to IV) services encompassing clinical project management and monitoring, biometrics, PK/PD modeling and simulation, and regulatory and medical affairs consultancy. SGS has its own clinical unit in Belgium and two phase I patient units based in Belgium and Hungary. SGS has a wealth of expertise in first in human (FIH) studies, viral challenge testing, biosimilars and complex PK/PD studies with a focus on oncology, infectious diseases, vaccines, and respiratory therapeutics.
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SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.