By: Lewis Cameron, CEO of Evestia Clinical
September 15, 2025
An ageing population, rising demand for personalised therapies, evolving regulation, and intense financial pressures are reshaping the biotechnology and pharmaceutical sector. As clinical trials become more complex and costly, partnering with the right contract research organisation (CRO) has never been more critical.
Rising costs demand a smarter CRO model
Clinical trials are the single largest component of R&D spending, consuming a majority of budgets due to their operational, regulatory, and logistical demands. In 2024, global R&D investment reached $288 billion, with the global clinical trials market valued at $59 billion. In today’s constrained funding environment, particularly for biotechs, companies are more discerning. They need CRO partners who are reliable, cost-effective, and committed to delivering high-quality outcomes on time and within budget.
To meet this demand, CROs must evolve, becoming more agile, data-driven, and innovative to support accelerated development timelines, precision medicine, and regulatory complexity.
One solution is a full-service specialist CRO model, offering integrated project management, regulatory affairs, clinical monitoring, data management, medical writing, quality assurance, and pharmacovigilance. This end-to-end approach spanning the drug development continuum offers customers tailored trial design solutions and faster execution.
Meeting the demand for cutting-edge therapeutic innovation
The shift toward personalised medicine, particularly in oncology, is transforming clinical trial needs. Trials incorporating biomarkers have increased significantly in the past decade. Biotech and pharma companies now require CROs with deep therapeutic expertise and customised teams capable of designing and running highly targeted studies and recruiting the right patients. Specialised CROs can unlock access to emerging technologies and streamlined processes to make trials faster, simpler, and more effective.
Navigating regulatory complexity
Global regulation is evolving rapidly. CROs must stay ahead of shifting frameworks to help sponsors succeed. In the UK, the Life Sciences Plan aims to reduce commercial trial set-up times from 250 to 150 days by March 2026. In the US, FDA pilot programmes aim to shorten new drug application reviews to just 1–2 months, enhance transparency, and promote real-time collaboration between sponsors and regulators.
Technology and AI will reshape clinical trials
Innovation is redefining how trials are delivered. The rise of remote monitoring, including wearable technology, improves patient access, lowers costs, and enhances data quality. CROs that adopt these technologies while maintaining compliance will have a competitive edge.
AI is also set to transform CRO services: from optimising trial protocols and accelerating patient recruitment, to predicting site performance, automating data cleaning, and enabling adaptive designs. These capabilities can significantly reduce timelines, cut costs, and boost trial success rates.
Building a world-leading specialist CRO
In a competitive market, a focused buy-and-build strategy can help CROs scale, enhance technology and therapeutic capabilities, and expand globally. But growth must be strategic. Acquisitions should align with core strengths, bringing therapeutic expertise, geographical reach, digital tools, and a strong reputation. Cultural fit is equally important; misalignment can undermine integration and stall progress.
To succeed in a rapidly evolving landscape, CROs must remain agile, investing in therapeutic depth, technology, and talent to help clients navigate change, accelerate development, and deliver life-changing therapies to patients, faster.
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