Recent News in the CRO Industry – A Snapshot
The Contract Research Organization (CRO) industry has been expanding rapidly in recent years, with new players entering the market and existing companies seeking growth opportunities through partnerships, acquisitions, and international expansion. Here is a quick summary of the latest news over recent weeks and months, and developments in the CRO industry.
French Clinical Trial Company Inato Secures $22M Funding to Expand International Growth
In March 2023, Inato, a clinical trial company based in France, announced that it had secured $22 million in series A2 funding to be used for international growth, product innovation, and to attract employees. The fundraising included lead investor Cathay Innovation and returning investor Obvious Ventures. New investors included La Maison and Top Harvest Capital. Inato will also direct the money toward oncology-specific innovation in an effort to increase access to care where trial enrollment rates are low despite the increasing rate of oncology studies.
According to Inato, 70% of clinical research is conducted at the same 5% of sites, and only 5% of patients participate in a clinical trial. The current status of the clinical trial industry has led to a lack of patient access that causes trial delays and increased costs. Only 4% of clinical trials in recent years have used a representative population, impacting a drug’s efficacy and safety, the company said. Inato’s efforts to expand access to clinical trials could help to address these issues.
Clinical Trial Diversity Drops to Lowest Level in 10 Years, IQVIA Finds
Despite recent efforts to increase diversity in clinical trials, a report by IQVIA found that clinical trial diversity in the US has dropped to its lowest level of the decade. Black and Hispanic patient inclusion in mid- and late-stage clinical trials declined over the past decade without ever meeting levels proportional with national demographics. However, both Black and Hispanic patient representation were lowest in oncology, a space that accounts for 40% of trial starts.
The report highlights the need for more diverse clinical trials to ensure that drugs are effective and safe for all populations. “We’ve been able to obtain some good recommendations from FDA on how to operationalize diversity plans, but clearly there’s still a lot of work to be done in this area,” said Rachael Anatol, Ph.D., senior vice president of science and regulatory affairs at Biotechnology Innovation Organization.
UK Regulator Makes Biggest Changes in 20 Years to Speed Up Trials, Attract Global Studies
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced several new measures to make it easier to run clinical trials in the country. The changes include integrating regulatory and ethics reviews of clinical trial applications, which in a pilot phase halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days. Additionally, the MHRA will implement a timeline for completion of an application review within a maximum 30 days with a 10-day limit for a decision to be granted once the regulator has received any final information.
The new framework also adds a legal mandate to register the trial in a World Health Organization public register and a requirement to publish a summary of results within 12 months of the end of the trial. The law includes the sharing of trial findings with participants in a timely manner. The MHRA hopes that these changes will attract global studies to the UK and speed up the clinical trial process.
TFS HealthScience – Contract Research Organization Continues Global Growth with Expansion into Israel
TFS HealthScience, a Sweden-based CRO, has been expanding globally through partnerships and acquisitions. In March 2023, the company announced that it had acquired parts of GCP Clinical Studies, a CRO based in Israel, to add to TFS’ experience in specialty therapeutics. Israel ranks in the top 20 countries in the world for registered pharmaceutical-sponsored clinical studies and boasts 1.5 to 3 times more decentralized clinical trial components than the global average.
The acquisition will also help TFS expand its geographic footprint in Israel and provide additional expertise in regulatory affairs. The company has been growing rapidly in recent years, and the acquisition of GCP Clinical Studies is just the latest example of its efforts to expand globally.
Clario Partners with Strados Labs to Offer Respiratory Tech for Clinical Trials
In March 2023, Clario, a Philadelphia-based clinical health tech company, announced that it had partnered with Strados Labs to use its FDA-approved monitoring device for clinical trials. The device, called the RESP Biosensor respiratory monitoring system, assesses lung sounds through smart sensor technologies and evaluates sounds like wheezing and coughing, which are then sent to clinician portals that can determine the level of care needed through the use of AI.
The device weighs as much as a pen and is less than half an inch thick, making it easy for trial participants to wear on their chest under clothes. The device downloads its information to the Clario portal when being recharged. The partnership will enable Clario to use Strados’ technology in its clinical trials, providing greater flexibility in the protocol design while reducing the burden for clinical sites and patients.
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These are just a few of the recent developments across the industry… The CRO market is rapidly evolving, with new players entering the market and existing companies seeking growth opportunities through partnerships, acquisitions, and international expansion. The latest news and developments in the industry suggest that companies are looking for innovative ways to improve patient access to clinical trials, increase diversity in clinical trials, and streamline the clinical trial process. As the industry continues to grow and evolve, it will be interesting to see what new developments emerge in the coming months and years!!