3 ways in which in silico trials can help CROs innovate and grow their business. The contract research organization market is on the rise. CROs have proven essential to providing support to the pharmaceutical, biotechnology, and medical device industries. In spite of this market’s growth, competition is very high: CROs need to innovate their business model in order to stay competitive, especially now that digitalization of R&D and reduction of time and costs are key factors for the pharmaceutical industry.
A market that is growing fast
According to a new market research report titled “Contract Research Organizations Market by Services (Clinical Research [Phase II, Phase III], Pre-Clinical [Pharmacokinetics, Toxicology], Laboratory Services, and others), Therapeutic Area (Oncology, Immunology), End-User (Pharma and Biotech, Medical Device), and Geography – Forecast to 2027” published by Meticulous Research (a leading provider of premium market intelligence), the contract research organizations market is expected to grow at a CAGR of 6.5% from 2020 to 2027 to reach $64.4 billion by 2027.
Since the development of drugs and devices is very complex and there’s a need to bring products to market rapidly to stay competitive and meet patients’ needs, pharmaceutical companies are increasingly outsourcing critical functions including manufacturing and research. This is why the hiring of CROs is growing dramatically.
CROs play a key role in all aspects of the drug or device development process, from initial discovery to launch, but usually, focus on Phase I–III clinical trials.
How can simulation help CROs be more efficient and innovative?
The regulatory has been supporting for years the use of in silico trials to speed up the development of new drugs and medical devices. Here are 3 ways in which in silico trials can help CROs grow their business, in compliance with the regulatory bodies:
1 Simulation can drastically reduce time and cost of R&D. According to McKinsey, more and more pharmaceutical companies are embracing digitalization to innovate their R&D, in the attempt to cut costs and accelerate the go-to-market of new drugs. Data coming from industries that have been using modeling & simulation for decades indicate a reduction of time and costs up to 50%. This would mean for CROs a chance to offer their clients outcomes in a shorter time at a reduced cost that can be shared, leaving CROs a higher markup. Plus, this gives the opportunity to do more trials with the same resources.
2 Simulation enables to work on rare diseases, too: thanks to highly reduced costs and the possibility to create a cohort of virtual patients, it is possible to conduct trials that otherwise would be impossible or too expensive. New business opportunities open up for CROs.
3 Simulation allows an innovative and ethical approach, by reducing in vivo experiments and the number of patients necessary to conduct a trial, though increasing diversity: virtual patients of different sex, age, body weight, pathological conditions are available. Therefore a CRO can ensure a level of safety that is higher than average, thanks to very extensive experimentation.
Simulation made easy
In spite of the many obvious advantages, modeling and simulation are still not adopted on a wider scale due to a series of obstacles: the necessity to buy appropriate and expensive hardware and software; their complexity, which requires specific resources to use them; the difficulty for most companies (except the big players) to create models that are sufficiently validated to make their outcomes easily acceptable by the regulatory.
The idea of InSilicoTrials is to put a complex subject such as numerical simulation within the reach of even non-experts: validated models created by internationally renowned scientists and universities are integrated into an easy-to-use platform with a unified interface. Some of our models are endorsed by the regulatory bodies, especially the FDA. The company’s research team helps CROs in the design of trials that exploit the ability of simulations wherever possible, alongside more traditional tests in order to arrive at a faster registration of the drug. And you can choose whether to use our cloud service, which guarantees access anywhere in the world, or whether to access our scientists, who manage the simulations for our customers.
A practical example
Drug-induced cardiac toxicity can be evaluated at the very beginning of drug development by using simulation. For instance, the Drug Safety Suite is a series of computational models that help reduce the risk of drug-induced cardiotoxicity. New molecules can be dangerous for the heart, causing even irreversible arrhythmias: by combining in vitro tests within silico tests, it is possible to identify safety liabilities in the early stages of development and therefore eliminate them immediately, reducing the time frame and costs of experimentation.