Merck uses a functional service provider (FSP) model, integrating CRO staff directly into their teams. They follow Merck processes and use Merck systems, creating a seamless experience for trial sites and avoiding the transactional conflicts and change orders common in fully outsourced models, which allows for greater agility.
For smaller biotechs, the key to a successful CRO relationship is treating them as a genuine partner. This requires moving beyond a transactional, fear-based dynamic to one of open communication and mutual respect. Biotechs should actively solicit CRO feedback, as they possess valuable cross-industry insights and can identify sponsor-side behaviors that need to change.
Despite a threefold increase in data collection over the last decade, the methods for cleaning and reconciling that data remain antiquated. Teams apply old, manual techniques to massive new datasets, creating major inefficiencies. The solution lies in applying automation and modern technology to data quality control, rather than throwing more people at the problem.
When integrating acquired biotechs, Merck prioritizes retaining key talent and preserving ongoing science. The strategy involves immediate face-to-face engagement to reduce anxiety, followed by a pragmatic assessment of which processes must be standardized versus which can remain to avoid disrupting critical trials, a practice they call avoiding 'mercification'.
Clinical trial protocols become overly complex because teams copy and paste from previous studies, accumulating unnecessary data points and criteria. Merck advocates for "protocol lean design," which starts from the core research question and rigorously challenges every data collection point to reduce site and patient burden.
Clinical trial sites are increasingly leveraging their power to demand protocol modernization from sponsors. Merck changed its internal processes to allow non-physician sub-investigators only after a site refused to participate without that flexibility. This shows that operational change can be driven from the ground up by partners, not just top-down by sponsors.
Instead of hiring expensive consultants who created chaos, Merck tasked a summer intern with shadowing their first major integration. The intern documented workflows and decisions in real-time, creating a practical, ground-up playbook that became the standard for all future acquisitions, proving a simple, low-cost solution can be most effective for knowledge capture.
Modernizing trials is less about new tools and more about adopting a risk-proportional mindset, as outlined in ICH E6(R3) guidelines. This involves focusing rigorous oversight on critical data and processes while applying lighter, more automated checks elsewhere, breaking the industry's habit of treating all data with the same level of manual scrutiny.