Latest news with #CRO
Yahoo
21-07-2025
- Business
- Yahoo
Medpace (NASDAQ:MEDP) Reports Strong Q2, Stock Jumps 46%
Clinical research company Medpace Holdings (NASDAQ:MEDP) reported Q2 CY2025 results exceeding the market's revenue expectations , with sales up 14.2% year on year to $603.3 million. The company's full-year revenue guidance of $2.47 billion at the midpoint came in 13% above analysts' estimates. Its GAAP profit of $3.10 per share was 3.5% above analysts' consensus estimates. Is now the time to buy Medpace? Find out in our full research report. Medpace (MEDP) Q2 CY2025 Highlights: Revenue: $603.3 million vs analyst estimates of $542 million (14.2% year-on-year growth, 11.3% beat) EPS (GAAP): $3.10 vs analyst estimates of $3.00 (3.5% beat) Adjusted EBITDA: $130.5 million vs analyst estimates of $117 million (21.6% margin, 11.5% beat) The company lifted its revenue guidance for the full year to $2.47 billion at the midpoint from $2.19 billion, a 12.8% increase EPS (GAAP) guidance for the full year is $14.15 at the midpoint, beating analyst estimates by 11% EBITDA guidance for the full year is $530 million at the midpoint, above analyst estimates of $473.7 million Operating Margin: 20.9%, up from 19.9% in the same quarter last year Free Cash Flow Margin: 23.6%, up from 19.6% in the same quarter last year Organic Revenue rose 14.2% year on year, in line with the same quarter last year Market Capitalization: $8.96 billion Company Overview Founded in 1992 as a scientifically-driven alternative to traditional contract research organizations, Medpace (NASDAQ:MEDP) provides outsourced clinical trial management and research services to help pharmaceutical, biotechnology, and medical device companies develop new treatments. Revenue Growth Examining a company's long-term performance can provide clues about its quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Luckily, Medpace's sales grew at an impressive 20.4% compounded annual growth rate over the last five years. Its growth beat the average healthcare company and shows its offerings resonate with customers, a helpful starting point for our analysis. Long-term growth is the most important, but within healthcare, a half-decade historical view may miss new innovations or demand cycles. Medpace's annualized revenue growth of 15.5% over the last two years is below its five-year trend, but we still think the results suggest healthy demand. Medpace also reports organic revenue, which strips out one-time events like acquisitions and currency fluctuations that don't accurately reflect its fundamentals. Over the last two years, Medpace's organic revenue averaged 15.7% year-on-year growth. Because this number aligns with its normal revenue growth, we can see the company's core operations (not acquisitions and divestitures) drove most of its results. This quarter, Medpace reported year-on-year revenue growth of 14.2%, and its $603.3 million of revenue exceeded Wall Street's estimates by 11.3%. Looking ahead, sell-side analysts expect revenue to decline by 2.4% over the next 12 months, a deceleration versus the last two years. This projection is underwhelming and implies its products and services will see some demand headwinds. At least the company is tracking well in other measures of financial health. Here at StockStory, we certainly understand the potential of thematic investing. Diverse winners from Microsoft (MSFT) to Alphabet (GOOG), Coca-Cola (KO) to Monster Beverage (MNST) could all have been identified as promising growth stories with a megatrend driving the growth. So, in that spirit, we've identified a relatively under-the-radar profitable growth stock benefiting from the rise of AI, available to you FREE via this link. Operating Margin Operating margin is a key measure of profitability. Think of it as net income - the bottom line - excluding the impact of taxes and interest on debt, which are less connected to business fundamentals. Medpace has managed its cost base well over the last five years. It demonstrated solid profitability for a healthcare business, producing an average operating margin of 19.4%. Analyzing the trend in its profitability, Medpace's operating margin rose by 2.8 percentage points over the last five years, as its sales growth gave it operating leverage. The company's two-year trajectory shows its performance was mostly driven by its recent improvements. These data points are very encouraging and shows momentum is on its side. In Q2, Medpace generated an operating margin profit margin of 20.9%, up 1 percentage points year on year. This increase was a welcome development and shows it was more efficient. Earnings Per Share We track the long-term change in earnings per share (EPS) for the same reason as long-term revenue growth. Compared to revenue, however, EPS highlights whether a company's growth is profitable. Medpace's EPS grew at an astounding 36.7% compounded annual growth rate over the last five years, higher than its 20.4% annualized revenue growth. This tells us the company became more profitable on a per-share basis as it expanded. Diving into the nuances of Medpace's earnings can give us a better understanding of its performance. As we mentioned earlier, Medpace's operating margin expanded by 2.8 percentage points over the last five years. On top of that, its share count shrank by 21.9%. These are positive signs for shareholders because improving profitability and share buybacks turbocharge EPS growth relative to revenue growth. In Q2, Medpace reported EPS at $3.10, up from $2.75 in the same quarter last year. This print beat analysts' estimates by 3.5%. Over the next 12 months, Wall Street expects Medpace's full-year EPS of $13.45 to shrink by 8.1%. Key Takeaways from Medpace's Q2 Results We were impressed by how significantly Medpace blew past analysts' expectations across all key metrics this quarter. We were also excited it lifted its full-year guidance. Zooming out, we think this was a solid print. The stock traded up 46% to $451 immediately following the results. Indeed, Medpace had a rock-solid quarterly earnings result, but is this stock a good investment here? The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-07-2025
- Business
- Yahoo
Pharma Contract Research Organization (CRO) Services Market to Cross USD 36.66 Billion in 2025, Expanding at a CAGR of 10.04%
The global pharma contract research organization (CRO) services market size is calculated at USD 36.66 billion in 2025 and is expected to reach around USD 87.03 billion by 2034, growing at a CAGR of 10.04% for the forecasted period. Ottawa, July 18, 2025 (GLOBE NEWSWIRE) -- The global pharma contract research organization (CRO) services market size was valued at USD 33.31 billion in 2024 and is predicted to hit around USD 87.03 billion by 2034, a study published by Towards Healthcare a sister firm of Precedence Research. The growth of the market is driven by the growing factors like increased research and development spending, a growing number of clinical trials, and the rising prevalence of chronic diseases, which drives the growth of the market. Get a quick preview of key market insights and trends shaping the Pharma CRO Services landscape: Key Takeaways North America dominated the global pharma contract research organization (CRO) services market in 2024. Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period. By scale of operation, the discovery services segment held a dominant presence in the market in 2024. By scale of operation, the preclinical services segment is anticipated to grow at the fastest rate in the market during the studied years. By target therapeutic area, the oncological disorder segment held the largest share of the pharma contract research organization (CRO) services market in 2024. By target therapeutic area, the cardiovascular disorder segment is estimated to grow at a significant rate during the predicted timeframe. Market Overview & Potential A pharmaceutical Contract Research Organization (CRO) provides a range of research services to biotech, pharmaceutical, and medical device companies. These include preclinical studies, clinical trial management, regulatory support, and more, helping clients develop and get approval for new drugs and medical devices. CROs bring specialized expertise and resources that support the entire drug development process, from initial research to post-market monitoring. They offer benefits such as saving costs and time, access to expert knowledge, allowing clients to focus on their core activities, and increasing efficiency and speed, making them an attractive choice for consumers. Access detailed data tables, segment analysis, and regional breakdowns in our comprehensive market databook: What is the Growth Potential Responsible for The Growth of The Pharma Contract Research Organization (CRO) Services Market? The market growth is primarily fueled by the rising number of clinical trials, increased outsourcing of R&D activities, and the demand for cost-effective drug development solutions. Technological innovations, especially in AI and machine learning, along with the growing complexity of clinical trials, further drive the market. Additional growth factors include more clinical trials by pharma and biotech firms, cost efficiency, advanced technologies, complex trial designs, regulatory pressures, an expanding pipeline of new therapies, the rise of personalized medicine, and the broader scope of CRO services. What Are the Growing Trends Associated with the Pharma Contract Research Organization (CRO) Services Market? Outsourcing Of Clinical Trials The factors such as cost efficiency, specialised expertise, and advanced technology demand for outsourcing of clinical trial services. Technological Advancement The integration of AI and ML for electronic data capture and electronic master files, and automating the processes, is a growing trend that drives the growth. Focus On Personalized Medicine and Biologics The growing demand for personalized medicines and biologics catering to the needs of the patient and consumers drives the growth of the market. Increased Research and Development Spending The growing pharmaceutical sector demand for research and development of new and innovative formulations, which demands CRO services, fuels market growth. You can place an order or ask any questions, please feel free to contact us at sales@ What Is the Growing Challenge in the Pharma Contract Research Organization (CRO) Services Market? The key challenge that limits the growth of the market is the regulatory complexity, as different landscapes and regions demand significant expertise and resources, which is a challenge in the growth of the market. The high operational costs are also a challenge, like technological advancements, skilled labor, and regulatory compliance, con contribute to the high operational costs, which limit the growth of the market. Regional Analysis How Did North America Dominate the Pharma Contract Research Organization (CRO) Services Market in 2024? North America dominated the global pharma market in 2024. The growth of the market is driven by technological advancements in the market to improve efficiency and speed of drug development through data analytics and AI fuels the growth of the market. The key players in the region also play a major role in the growth due to the offering and innovation in product development, which drives the growth like IQVIA, Laboratory Corporation of America Holding, Syneos Health, Parexel International Corporation, and ICON plc are some of the major players in the region. The growth is also seen as driven by research and development spending, focus on chronic diseases, and growing demand for outsourcing of research; these factors boost the growth of the market in the region. Contract Research Organization (CRO) services in the U.S. are growing through increased outsourcing of clinical trials, rising biotech startups, and FDA support for faster approvals. Technological integration, decentralized trials, and access to diverse patient populations also drive expansion, making the U.S. a global hub for clinical research innovation. Canada's pharma contract research organization (CRO) services are expanding steadily through increasing biotech-pharma collaborations, government innovation funding, and adoption of virtual and AI-enabled clinical trials. Regulatory reliance on CROs for compliance, combined with growing oncology and rare-disease studies, is driving wider use across provinces. What Made Asia Pacific Significantly Grow in The Pharma Contract Research Organization (CRO) Services Market In 2024? Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period. The growth of the market is driven by the increasing R&D spending, growing clinical trials, outsourcing trends, technological advancements, and cost effectiveness, which fuels the growth of the market in the region. The technological advancements and stringent regulatory standards attract companies that focus on the development of innovative drugs, which boosts the growth of the market. The expanding pharmaceutical companies, biotechnology firms, and medical devices companies in the region also promotes the growth of the market. The pricing and growing pool of skilled professionals in the region also contribute to the growth of the market. CRO services in China are growing through supportive regulatory reforms, such as faster clinical trial approvals and acceptance of foreign trial data. The government encourages innovation, prompting CROs to expand capabilities across drug discovery, toxicology, and clinical operations. Collaborations between academic institutions and CROs are increasing, and the growing pool of trained clinical researchers is enhancing service quality. Additionally, many CROs are integrating digital tools and AI to streamline trial processes. India's CRO growth is driven by a skilled, English-speaking workforce, a large and diverse patient population, and improvements in regulatory efficiency. Academic partnerships and government-backed innovation hubs foster research collaboration. CROs are adopting advanced technologies like remote monitoring, e-clinical platforms, and AI-based data analysis. Training programs enhance GCP compliance and clinical staff proficiency. Get the latest insights on life science industry segmentation with our Annual Membership: Segmental Insights By Scale Of Operation The discovery services segment held a dominant presence in the market in 2024. Discovery services represent a foundational segment in the pharma contract research organization (CRO) services market, focusing on early-stage research to identify promising drug candidates. These services include target identification, hit discovery, lead optimization, and assay development, providing critical scientific insights before preclinical studies begin. By outsourcing discovery work, pharmaceutical companies can accelerate timelines, reduce costs, and access specialized expertise. The growing demand for innovative therapies and rapid pipeline expansion strongly supports the growth of discovery services within the CRO market. The preclinical services segment is anticipated to grow at the fastest rate in the market during the studied period. Preclinical services are a crucial segment of the pharma contract research organization (CRO) services market, focusing on evaluating drug candidates' safety and efficacy before human trials. These services include toxicology studies, pharmacokinetics, pharmacodynamics, and bioanalytical testing, providing essential data for regulatory submissions. By outsourcing preclinical work, pharmaceutical companies reduce development costs, access advanced technologies, and accelerate timelines. The increasing complexity of drug molecules and stricter regulatory standards drive demand for preclinical services, fueling the growth of the CRO market globally. By Target Therapeutic Area The oncological disorder segment held the largest share of the pharma contract research organization (CRO) services market in 2024. Oncological disorders represent a major target therapeutic area in the pharma market, driven by the urgent need for effective cancer treatments. CROs support pharmaceutical and biotech companies by providing specialized services across the drug development spectrum, including discovery, preclinical, and clinical studies focused on oncology. The complexity of cancer research, demand for targeted and personalized therapies, and rising global cancer incidence fuel this segment's growth, making oncology one of the most heavily invested areas in CRO services worldwide. The cardiovascular disorder segment is estimated to grow at a significant rate during the predicted timeframe. Cardiovascular disorders are a significant target therapeutic area in the pharma contract research organization (CRO) services market, driven by the high global prevalence of heart-related diseases. CROs support drug development for cardiovascular therapies through specialized discovery, preclinical, and clinical services, including safety assessments, efficacy studies, and biomarker analysis. The need for innovative treatments to address heart failure, hypertension, and related conditions fuels demand for CRO expertise. This strong focus supports market growth and advances the development of life-saving cardiovascular drugs worldwide. Elevate your healthcare strategy with Towards Healthcare. Enhance efficiency and drive better outcomes schedule a call today: Recent Developments in the Pharma Contract Research Organization (CRO) Services Market In March 2025, LSK Global Pharma Services selected Oracle Argus to manage and expand its global pharmacovigilance operations, for the management of the databases of pharmaceutical companies, ensuring safety. In November 2024, Thermo Fisher Scientific launched a suite of expanded CRO and CDMO services under its brand. The company has introduced to the market its Accelerator™ Drug Development, which Thermo Fisher is marketing as '360°' CDMO and CRO drug development solutions. Top Companies and Their Contributions to the Pharma Contract Research Organization (CRO) Services Market Company Contributions & Offerings IQVIA A leader in data-driven CRO services, IQVIA offers clinical development, real-world evidence, and technology-enabled solutions globally. Parexel International Specializes in regulatory consulting, Phase I-IV clinical trials, and biotech partnerships, with a focus on patient-centric trials. Medpace Provides full-service clinical trial management, emphasizing therapeutic expertise and in-house services like labs and imaging. Charles River Laboratories Offers preclinical and early-phase clinical services, with expertise in drug discovery, safety assessment, and lab sciences. CTI Clinical Trial & Consulting Focuses on rare diseases and regenerative medicine, offering personalized CRO services from preclinical to commercialization. WuXi AppTec Delivers comprehensive R&D solutions, including lab testing, manufacturing, and clinical services, mainly serving pharma and biotech. Veeda Clinical Research India-based CRO offering cost-effective early and late-phase clinical trials, bioavailability and bioequivalence studies. ICON plc A global CRO with expertise across all phases, providing clinical development and commercialization support using advanced analytics. LabCorp (Covance) Integrates diagnostics and drug development, offering end-to-end clinical trial services through its Covance division. Syneos Health Blends clinical development with commercialization, offering biopharma integrated solutions and a strong site-network model. Top Companies in the Pharma Contract Research Organization (CRO) Services Market IQVIA Parexel International (MA) Corporation Medpace Charles River Laboratories CTI Clinical Trial & Consulting WuXi AppTec Veeda Clinical Research ICON plc Laboratory Corporation of America Holdings Syneos Health Browse More Insights of Towards Healthcare: Medical Device CRO Market:The medical device contract research organization (CRO) market is valued at USD 8.49 billion in 2024, grows to USD 9.25 billion in 2025, and is expected to reach USD 19.9 billion by 2034, with a strong annual growth rate (CAGR) of 8.98%. Biopharmaceuticals CRO Market:The biopharmaceuticals contract research organization market is expected to grow steadily from 2025 to 2034, potentially reaching hundreds of millions of dollars in revenue during the forecast period. Healthcare CRO Market:The healthcare contract research organization (CRO) market is estimated at USD 53.87 billion in 2024, rises to USD 57.66 billion in 2025, and could reach USD 106.25 billion by 2034, growing at a CAGR of 7.04%. Preclinical CRO Market:The preclinical contract research organization (CRO) market is expected to grow from USD 6.8 billion in 2025 to USD 14.34 billion by 2034, at a CAGR of 8.73%. Biologics CRO Market:The biologics contract research organization market is valued at USD 31.15 billion in 2024, will grow to USD 35.22 billion in 2025, and is projected to reach USD 106.28 billion by 2034. Biotechnology & Pharmaceutical Services Market:The biotechnology and pharmaceutical services market stands at USD 76.51 billion in 2024, increases to USD 80.7 billion in 2025, and is expected to reach USD 130.56 billion by 2034, growing at a CAGR of 5.48%. Pharmaceutical Spray Drying Market:The pharmaceutical spray drying market is calculated at USD 2.37 billion in 2024, grows to USD 2.55 billion in 2025, and is projected to reach USD 4.93 billion by 2034, with a CAGR of 7.67%. Biopharmaceutical Third-Party Logistics Market:The biopharmaceutical third-party logistics (3PL) market is estimated at USD 143.44 billion in 2024, grows to USD 152.93 billion in 2025, and could hit USD 276.24 billion by 2034. Cold Chain Pharmaceuticals Market:The cold chain pharmaceuticals market is valued at USD 6.42 billion in 2024, increases to USD 6.67 billion in 2025, and is projected to reach USD 9.33 billion by 2034, with a CAGR of 3.83%. Radiopharmaceutical Market:The radiopharmaceutical market is worth USD 6.8 billion in 2024, grows to USD 7.32 billion in 2025, and is expected to reach USD 14.11 billion by 2034, expanding at a CAGR of 7.57%. Regions Covered North America U.S. Canada Asia Pacific China Japan India South Korea Thailand Europe Germany UK France Italy Spain Sweden Denmark Norway Latin America Brazil Mexico Argentina Middle East and Africa (MEA) South Africa UAE Saudi Arabia Kuwait Download the complete strategic report with deep analysis, forecast and competitive intelligence tailored for decision-makers: You can place an order or ask any questions, please feel free to contact us at sales@ Gain access to the latest insights and statistics in the healthcare industry by subscribing to our Annual Membership. Stay updated on healthcare industry segmentation with detailed reports, market trends, and expert analysis tailored to your needs. Stay ahead of the curve with valuable resources and strategic recommendations. Join today to unlock a wealth of knowledge and opportunities in the dynamic world of healthcare: Get a Subscription About Us Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics to the healthcare sector, committed to forming creative connections that result in actionable insights and creative innovations. We are a global strategy consulting firm that assists business leaders in gaining a competitive edge and accelerating growth. We are a provider of technological solutions, clinical research services, and advanced analytics to the healthcare sector, committed to forming creative connections that result in actionable insights and creative innovations. 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Business Upturn
17-07-2025
- Business
- Business Upturn
Novotech Report: How In-Vivo CAR-T May Reshape Cell Therapy Economics
Business Wire India With in-vivo CAR-T therapies gaining global momentum, a new whitepaper from Novotech, a leading global full-service clinical Contract Research Organization (CRO) and scientific advisory company, offers insight into this next frontier of immunotherapy. In-Vivo CAR Therapies – Global Research and Development Landscape (2025) report explores the accelerating innovation in in-vivo CAR-T (Chimeric Antigen Receptor) technologies and their potential to reshape treatment across oncology, autoimmune diseases, and other complex indications. This press release features multimedia. View the full release here: In Vivo Car T Infographic from Novotech Traditional ex-vivo CAR-T therapies require extracting a patient's T cells, engineering them in specialized labs, and reinfusing them, a process that is time-intensive, expensive, and logistically complex. These barriers have significantly restricted patient access. In contrast, in-vivo CAR-T therapies aim to overcome these challenges by engineering T cells directly within the patient's body using delivery technologies such as viral vectors, lipid nanoparticles (LNPs), and advanced mRNA platforms. The result: faster, more scalable, and potentially off-the-shelf treatments that can expand access, reduce costs, and streamline the patient experience. In-vivo CAR-T platforms are now being explored not only for hematologic malignancies, but also for solid tumors and autoimmune diseases—areas where traditional CAR-T approaches have faced limitations. Emerging delivery innovations and new combination strategies are driving this expansion. As a result, in-vivo CAR-T therapies are positioned to reshape clinical practice, expanding their applicability across oncology, autoimmune diseases, and beyond. The report provides key insights for sponsors, investors, and researchers into one of the most transformative areas of next-generation cell therapy. It includes: The technological evolution of CAR platforms and delivery systems. The expanding global pipeline of in-vivo CAR assets and clinical programs. Innovations in lipid nanoparticle (LNP) and viral vector delivery strategies. Commercial and regulatory considerations shaping future adoption. Opportunities for in-vivo CAR approaches beyond oncology, including autoimmune diseases and fibrosis. Novotech has an established track record of supporting in-vivo CAR-T programs globally, including conducting the world's first in-vivo CAR clinical trial, highlighting its leadership and deep expertise in advanced therapeutics, including gene and cell therapies. The company has also conducted more than 100 ATMP studies, spanning gene therapies, gene-modified cell therapies, and mRNA products. Novotech is also actively partnering with biotech sponsors advancing in-vivo CAR pipelines. Download the full whitepaper to explore the key trends and opportunities driving the future of in-vivo CAR-T therapy. About Novotech Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company trusted by biotech and small- to mid-sized pharmaceutical companies to guide drug development at every phase. With a global footprint that includes 30+ offices across the Asia-Pacific region, North America, and Europe and partnerships with 5,000+ trial sites, Novotech provides clients an accelerated path to bring life-changing therapies to market by providing access to key clinical trial destinations and diverse patient populations. Through its client-centric service model, Novotech seamlessly integrates people, processes, and technologies to deliver customized solutions that accelerate the path to market for life-changing therapies. By adopting a true partnership approach, Novotech shares a steadfast commitment to client success, empowering innovation, and advancing healthcare worldwide. Recipient of numerous industry accolades, including the Frost & Sullivan CRO Company of the Year award for 19 consecutive years, Novotech is recognized for its excellence in clinical trial execution and innovation. Its deep therapeutic and regulatory expertise, combined with local market insights, ensures streamlined clinical trials, optimized data analytics, and accelerated patient recruitment strategies. Together with clients, Novotech transforms scientific advancements into therapies that improve global health outcomes, embodying a mission of driving innovation and delivering impactful results. For more information or to speak to an expert team member visit View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash
Irish Independent
15-07-2025
- Business
- Irish Independent
Almost 40,000 companies face strike-off over ownership details
The Companies Registration Office (CRO) now has the power to deal with such firms, and almost 40,000 companies are facing a sanction. The mandatory Register of Beneficial Ownership (RBO) was established under the EU's fourth money laundering directive, commonly known as MLD4. The registers were established across the trading bloc and contain beneficial ownership details of all companies and societies established in each state. The initial deadline for submitting ownership details was in November 2019. Companies and societies that fail to file the required ownership details can be fined up to €500,000. Any person who knowingly or recklessly makes a materially false statement to the RBO can be subject to a prison sentence of up to 12 months. The CRO said that between 10pc and 12pc of companies and societies have failed to file ownership details and will now be at risk of sanction. At a recent stakeholder meeting the CRO declined to specify when it will start the strike-offs for those firms, but confirmed the process is set to get under way shortly. Non-compliant entities will first receive a warning from the RBO, with the CRO then handling any required strike-offs. While thousands of firms have not filed details, just a tiny number have been prosecuted. ADVERTISEMENT The RBO began prosecuting non-complaint entities in the second quarter of 2022. Five companies were charged that year with failing to file the correct details and each was convicted and fined €3,000. Four others pleaded guilty and had the Probation Act applied. The following year, cases against 15 entities were heard in the district court. Eight were convicted, while seven pleaded guilty, and the Probation Act was applied. At its stakeholder meeting last month, the CRO noted that in May of this year, one case was heard and resulted in a conviction. Five cases were due to be heard yesterday. The process for striking off companies due to failure to file ownership details is expected to mirror that used in dealing with entities that have failed to file annual returns on time. Normally, the involuntary strike-off procedure involves a 10-week warning letter issued to a company's email address 180 days after the annual return date. This is followed by an involuntary strike-off notice sent to directors at their home addresses. Public access to the Irish RBO was shut down in 2022 following a controversial ruling by the European Court of Justice. It found public access to such registers was incompatible with business owners' privacy rights enshrined in the General Data Protection Regulation. The public now only has a right to restricted access to the Irish RBO. Just one request was made last year to Ireland's RBO for details of a firm by a person who claimed legitimate interest in doing so. The request was rejected.
Yahoo
10-07-2025
- Business
- Yahoo
Adapting to funding and operational hurdles in today's clinical trials landscape
Against the backdrop of geopolitical tensions and economic measures such as tariffs, which are influencing supply chains across numerous industries, biotech companies are facing significant capital constraints, which in turn affect clinical trial activity. At the 12th Annual Outsourcing in Clinical Trials (OCT) UK and Ireland, which took place in June in London, UK, industry leaders delivered comprehensive insights and examined current market trends in today's clinical trials landscape both in the UK and on a global level. At the meeting, Aditya Kotta, head of business development of US and EU at global contract research organisation (CRO) Novotech, said investors are placing greater emphasis on later-stage data to overcome funding challenges. He said that in the case of early-stage assets, companies are now prioritising proof-of-concept data and streamlining their focus to achieve that swiftly and efficiently. In some cases, companies may concentrate resources on a single lead asset to maximise the likelihood of generating compelling data. Over the past several months, particularly in the last two quarters, Kotta has observed a noticeable shift among biotech companies that are pushing towards 'ex-US' strategies in clinical development, namely a switch towards regions such as Australia, Asia-Pacific, Eastern Europe, and even China for early-phase clinical trials. Such a trend reflects a growing strategic interest in diversifying trial geography to capitalise on the advantages offered by these regions, Kotta noted. According to Kotta, Australia has emerged as a leading location for early-phase trials due to a favourable regulatory environment, reduced costs, and high-quality data output. Countries such as Australia and New Zealand are also experiencing a lower rate of decline in clinical trial activity compared to the US. An analysis of clinical trial registries, including and Australian and New Zealand registries, showed a significant and notable decline in clinical trial activity, approximately 20% year over year, when comparing H1 2024 to H1 2025. 'Oncology trials typically make up about 30% to 40% of the market share of total clinical trials,' Kotta said. But between H1 2024 and H1 2025, there was an approximately 60% drop in oncology trial activity. Although nearly all therapeutic areas have seen reductions in clinical activity, some have demonstrated relatively strong resilience. Trials focused on obesity and RNA-based therapeutics continue to show robust performance and retain investor interest. Another key theme that was discussed at length at OCT UK & Ireland was the issue of patient and site engagement. The issue of non-enrolling clinical sites is not new and remains a consistent challenge across the industry, according to Esther Kitto, vice president of clinical operations at Resolution Therapeutics, which is developing a regenerative macrophage therapy for patients with end-stage liver disease. She acknowledged that Resolution's recruitment model, where patients are referred or follow a natural treatment pathway, has remained largely unchanged over the last two decades. However, the UK-based biotech is making strides to widen outreach and participation, expand the patient pool, increase recruitment rates, and reduce the number of inactive sites to address enrollment inefficiencies. Also advocating for revising old models of trial recruitment and management was TRI CEO Duncan Hall. The risk-based quality management (RBQM) employed by TRI analyses trial data to identify risks to trial success early, and allows coordinators to respond accordingly, replacing prior labour-intensive systems, as Hall told Clinical Trials Arena. 'RBQM adoption is on the rise…but the benefits from RBQM are not being fully realised,' Hall stated. He said TRI is now looking to incorporate AI techniques into its methodology, but human interaction will always be core to trial monitoring, with the patient-investigator relationship remaining key. Kitto said that recent findings show that nearly 30% of patients drop out of trials, not due to adverse events or safety concerns, but due to fatigue or lack of motivation. She added that patient retention is crucial, not just for ethical reasons, but also for maintaining data integrity. Patient advocates are keen to build closer ties with trial coordinators and industry, said Richard Stephens, a patient advocate from the Cancer Research Advocates Forum (CRAF-UK). He added that from patients to drug developers, it is in the interests of all parties involved to see timely and successful trial enrollment to support both the scientific goals of trials and the hopes held by participants for innovative cures and improved overall care. Stephens also called for closer collaboration between patient advocacy groups, especially across national boundaries, to facilitate greater enrollment through international trials. Kitto said that such collaborations go beyond simply sharing patient-facing documents such as information sheets and brochures. Resolution now shares full protocols with advocacy groups, enabling them to provide input on trial design aspects, including the number of interventions and procedures, as well as overall patient burden. She also stated that this inclusive approach aims to ensure that trials are more aligned with patient needs and experiences, promoting both transparency and engagement. Nonetheless, certain approaches to engaging with patients require greater forethought. The potential use of AI to enhance patient engagement was discussed in the second day's keynote address by Blanka Hezelova, associate director at GSK. In particular, Hezelova noted that trial forms used to establish informed patient consent are often viewed as complex, impersonal, and unclear with regard to data privacy. Hezelova stated that with the advent of advanced AI, consent forms can be personalised to individual participants, expressed in plain language, and driven by data. However, she warned: 'AI, unfortunately, does have a very serious risk of becoming coercive and manipulative,' and highlighted concerns around AI hallucinations and bias. Hezelova, therefore, stressed the continued need to train human trial coordinators and clinicians to offer in-person guidance as central to ensuring the trust of participants, key to addressing enrollment challenges. As regulatory bodies lag behind the pace of AI progress, she said developers and CROs must prepare for a transition period of clinical AI characterised by 'transformation, long-term changes'. In regard to clinical trial challenges specific to the UK, Kitto noted that the decentralised nature of the National Health Service (NHS) complicates trial setup timelines. Kitto proposed having centralised coordination within each hospital or NHS trust and a dedicated individual overseeing all clinical trial setup logistics, which could streamline these processes. Further challenge comes from limits on NHS staff capacity to engage in clinical trials. The research workforce is a major bottleneck to NHS-led trials, according to Karolin Kroese, programme office lead at the Experimental Cancer Medicine Centre Network. The issue is compounded by a fundamental lack of career growth opportunities, said Dr Davy Yeung, COO at British CRO TCR Solutions. 'There is no career pathway for research nurses,' he stated, with many seeking advancement through other careers such as academia. However, recent changes to the UK Medicines and Healthcare products Regulatory Agency (MHRA's) Innovative Licensing and Access Pathway (ILAP) can be expected to accelerate patient access to new medicines through improved collaboration between national healthcare systems and drug developers, as per Dr Austin Smith, CMO of Sweden-based Oxcia. Expected updates to the 2004 Medicines for Human Use (Clinical Trials) Regulations to facilitate medicine manufacture near points of patient care were cause for optimism, according to Shasheen Payoe, PhD, clinical account manager at Germany-based Miltenyi Biotec. With new clinical trial regulations on the horizon, there is an opportunity to move the industry forward, said Sarah Deely, director of country and site operations at Biogen. Biogen is proactively engaging with key regulatory and policy stakeholders, including the MHRA, National Institute for Health and Care Research (NIHR), and the Association of the British Pharmaceutical Industry (ABPI), not just as participants, but as collaborators in shaping these regulations. Deely added that Biogen is also deeply involved in the rollout of the Clinical Research Delivery Centres (CRDCs)—regional hubs established across the UK to facilitate and accelerate research. She stated that the company, which is conducting trials in rare diseases, co-develops its protocols with global and UK-based medical experts to reduce the burden on both patients and sites. Deely added that the aim is to avoid unnecessary amendments later and to align protocols with UK healthcare realities, including post-approval reimbursement and long-term care needs. Additionally, some UK hospitals have embedded patient and public involvement (PPI) teams to link sponsors, medical experts, and patients to ensure operational efficiency and patient-centricity. The UK's NHS should be more fundamentally centred around clinical trials through collaboration with industry to foster greater innovation in the country's pharmaceutical sector, said Stephens. Though he recognised the strain on resources experienced by many hospitals, Stephens remained convinced the UK could shore up its clinical trials sector. "Adapting to funding and operational hurdles in today's clinical trials landscape" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
