R&D in Life Sciences: The Data & AI Playbook
Kubrick Group
Helping organizations realize lasting value from data & AI with a workforce we build ourselves
Making R&D compliance processes work for you - not against you - while minimizing waste and risk
Although AI is creating new compliance challenges for Life Sciences organizations as regulators begin to impose their requirements for ethical and safe AI implementation, it will also help overcome many of the notably stringent compliance hurdles in pharmaceutical, medical device, and biotech development. The difficulty and expense of this regulation is evident: it typically takes over 10 years and up to £2 billion to bring a drug to market. The cost per pipeline asset in the R&D process has been on the rise, nearly doubling since 2013[1] (see fig i), making margin squeeze even more prevalent.
Meanwhile, regulatory scrutiny is only intensifying. In the EU, the EMA recently published updated guidelines for good pharmacovigilance practices (GVP) with additional measures to support risk minimization[2], following the introduction of the Clinical Trials Regulation in 2022[3]. Likewise in the US, the FDA published draft guidance for current Good Manufacturing Practice (cGMP) in January 2025[4], with a focus on the use of ‘advanced manufacturing processes’ such as analytical modelling in batch testing. For global organizations, the challenge of compliance is thus exacerbated by regulatory divergence post-Brexit and with the expansion of US/EU requirements, demanding more agility in compliance frameworks.
In the face of heightened regulatory pressure, most organizations are still incumbered by manual processes which are both time-consuming and prone to error, increasing the risk of warning letters, product holds, or supply chain disruption. R&D and production compliance has become a significant bottleneck for innovation and production, and, ultimately, a drain for P&L as labor costs and failure to meet procedural requirements waste millions in time, materials, and time-to-market.
The Data & AI Playbook: Harnessing Generative AI to Govern and Accelerate Compliance
Challenge: Manual regulatory compliance operations dilute innovation
The toll of the increasing stringency of regulation results in minimized time and capacity for highly qualified R&D professionals to complete high-value work. Instead, the day-to-day operations can look like sifting through digital documents and waiting for response from internal support services, amassing days and weeks in wait time, instead of moving forward in research. The issue is exacerbated by the prevalence of human error in these manual search and extraction processes, which further delay research or add risk to non-compliance as research develops.
Case Study: Creating a bespoke Generative AI chatbot to expedite Standard Operating Procedure (SOP) document access
We uncovered a repeated pain point in the R&D compliance process for a largescale pharmaceuticals business that could be eliminated by Retrieval Augmented Generation.
The situation
The R&D team struggled to access the relevant Standard Operation Procedure (SOP) documents and other vital compliance documents they required when conducting research, incumbered by the sheer volume and vastness of document storage across their internal systems, only helped by slow communication channels like Support inboxes and ticketing systems which would take 24+ hours to return a response for a document location.
Our approach
We created an end-to-end Generative AI system that enables R&D researchers to query a Generative AI chatbot to retrieve and highlight the necessary information in less than a minute. Ingesting millions of pages of PDFs from across systems, which are contextualized by auto-generated metadata, the embedding model is able to retrieve and rerank information to deliver the most relevant information. The end user can interface with the LLM Virtual Assistant in natural language.
The impact
The R&D Compliance Virtual Assistant not only expedites critical regulatory processes from hours to minutes, allowing researchers to spend more time on high-value work instead of manual search, but does so with greater accuracy than human efforts. The LLM is able to complete tasks with over 90% accuracy, exceeding the ungoverned manual search tasks which often do not account for difficult regional discrepancies and requirements, creating additional risks to compliance – which frequently end up costing millions in fines or delayed trials.
Challenge: Regulatory submission requirements inhibit time-to-market from inception
Despite the many complexities of the drug discovery, development, and trial cycle, one of the most challenging hurdles to reach market is the acceptance by global authorities to enter the market. Research has found that the average acceptance rate of core documents across the US, EU, Japan, and Canada ranges from 45% to 57%, with overall likelihood of just 8.7% to be accepted in all four markets[6].
The crux of the issue is not within the science or safety of the product, but in the compliance: differing regulatory requirements and standards across markets and inadequate documentation and quality of response should be the aspects that are easiest to address, control, and succeed, but too often lead to rejection and repeated efforts.
Case Study: Creating a Fine-Tuned LLM to improve first time submission rate
A world-leading Life Sciences organization wanted to understand the power of Generative AI to reduce regulatory failures which slow time-to-market on lifesaving drugs.
The situation
When submitting for approval on new drugs, the client’s manual document review process was both time-consuming and highly prone to human-error, causing low first-time approval rates of just 50%. The equally manual and reactive approach to responding to regulator queries caused further delays, contributing to the overall 10+ year timeline to bring a new drug to market.
Our approach
We helped design powerful LLM to help quickly generate submission responses which meet the required standards first time, with improved accuracy on human responses. Leveraging historic documents, we fine-tuned the model to identify patterns and predict questions from regulators, driving efficiency in improved repeatability and quicker response times to overcome bottlenecks.
The impact
The Proof of Concept (POC) demonstrated capability to improve submission rates by 10-20%, which is projected to save 3-6months in regulatory cycles. This equates to an estimated value of $50-100m per drug, between reduced operational costs and earlier market entry.
Other strategic Data and AI applications:
Learn more: Read the Full Report
Intensifying R&D regulation and rising asset costs are just two pieces in the macroeconomic jigsaw which is altering the way Life Sciences organizations are constructed. In a brand new report from Kubrick, Creating Enterprise Resilience in Life Sciences: The Data & AI Playbook, we unpack the many ways pharmaceutical and life sciences organizations can embrace data and AI to stay ahead of tariff turbulence, regulatory restrictions, and competitive disruption.
Access the full report now: https://www.kubrickgroup.com/industry-outlook-life-sciences
About Kubrick
Kubrick exists to transform lives through data & AI. We help global organizations realize lasting value from data and AI with a workforce we build ourselves.
We deliver data and AI solutions that minimize operational cost, strengthen resilience against risk, and uncover revenue opportunity. Our clients can retain our people to drive lasting adoption while futureproofing their workforce with exceptional talent.
Since 2016, we’ve created over 3,000 data & AI specialists by removing the systemic barriers to the tech industry. We find incredible minds from all backgrounds to train with us, creating a diverse team of experts. We’re the preferred partner of today’s leading technology providers, including Databricks, Snowflake, and Collibra, to accelerate delivery and co-create revolutionary solutions.
Learn more about our data and AI solutions and talent: speaktous@kubrickgroup.com
Chair & CEO
2mo💡 Great insight