How CROs are Driving Pharmaceutical R&D
Chris Stumpf, Senior Principal Marketing Professional, Revvity Signals
Global pharmaceutical giants rely on contract research organisations (CROs) to accelerate the pace of drug discovery. Indian CROs are set to play a central role, with predicted annual market size growth of more than 10 per cent. To seize the opportunity, CROs are looking to digital platforms to transform their operations.
Global pharmaceutical giants rely on the burgeoning Contract Research Organization (CRO) sector to accelerate the pace and depth of new drug discovery. In this marketplace, Indian CROs play an increasingly central role, with predicted annual market size growth of more than 10 per cent.1 To enable research and development programmes with teams that span the globe, CROs are adopting advanced digital platforms, revolutionising worldwide collaboration and transforming operations.
In common with many industries, pharmaceutical companies continue to strip away costs, outsourcing activities to partners that can offer process efficiencies and economies of scale. Capitalising on the opportunities presented by this trend, the global CRO sector is growing fast, with forecast growth of up to 7 per cent annually2.
CROs based in India are outperforming even this forecast, with a predicted 10 per cent annual growth—a 50 per cent advantage against the global 7 per cent rate. Alongside the benefits springing from outsourcing to companies that have invested in a large and highly trained workforce of specialists, the key underlying factor of the success of Indian CROs seems to be their rapid and enthusiastic adoption of advanced digital platforms.
Drug discovery driven by data
Modern projects involve vast volumes of data, with massive datasets that are often difficult to unify, navigate, and process. The outcome is that scientists may spend significant time on data cleaning and administration tasks rather than strategic problem solving. In this scenario, with constant pressure to increase project throughput, high-workload environments will benefit significantly from any incremental boost to productivity, and rapid data access can deliver major efficiency gains.
In this rapidly changing environment, even as global collaboration between pharmaceutical majors and CROs evolves and expands, drug discovery itself is undergoing its own revolution and the demand for faster research processes is on the rise, fueled by machine learning (ML) and artificial intelligence (AI), with effective management of vast and complex scientific datasets valued highly. Indeed, from 2024 to 2030, the use of lab-based information management platforms in India is set to grow annually by 9.7 per cent3. Naturally, during this expansion, CROs must navigate issues related to data integration, quality control, and regulatory compliance, all while maintaining their competitive edge.
Specific operational challenges spring from the nature of extended global team working within a CRO. Data often arrives from multiple sources and in different formats, making it difficult to integrate and analyse, and manual normalisation processes carry the risk of human error. In addition, as data volumes continue to rise, the lack of scalability inherent in manual processes can impact time-to-market and incur rising costs.
Driven by the desire for operational efficiency, CROs in India are enthusiastic adopters of digital technologies, deploying shared platforms and standards to help optimise workflows. By moving to the latest advanced digital platforms, Indian CROs are sweeping aside the traditional blockers to progress, and creating globally integrated processes that are fueling extraordinary growth.
Moreover, digital platforms are creating new possibilities for CROs, as the new capabilities inspire innovative new research programmes and workflows — in effect, CROs in India are becoming powerful R&D hubs in their own right.
Key elements supporting CRO digital transformation
Data integration and workflow management: Digital platforms enable the seamless flow of R&D data across teams and geographies, using standardised processes and formats. Data is centralised and always easily accessible to help inform research decisions, while workflow https://www.grandviewresearch.com/ horizon/outlook/laboratory-informationmanagement-system-market/india management tools help to streamline research programs, reducing the time and effort required to complete tasks.
AI-driven analytics: AI-driven analytics tools can process very large datasets rapidly and generate insights that could be difficult or impossible to obtain manually. By using predictive modelling to narrow the range of candidates rapidly, the newest AI solutions can accelerate the drug development process and help CROs to make informed research decisions more quickly.
Automated compliance and documentation: In a global marketplace, compliance with multiple and continuously evolving global regulatory frameworks can represent a significant challenge. Digital platforms can automate many aspects of compliance, such as traceability, data integrity and quality control, helping to reduce the risk of errors and to ensure that both local and global standards are met.
Collaborative research ecosystems: Using digital platforms CROs are able to transform the work experience, particularly for extended teams that include multiple locations and many clients, suppliers and partners. Digital solutions provide secure, real-time data sharing and collaboration, and all stakeholders gain access to best practice and knowledge.
Cloud-enabled scalability: Cloud-based platforms remove the need for large on-premises systems and eliminate maintenance and support headaches. The near-limitless processing and storage capacity of cloud-based solutions help CROs scale up very rapidly to manage data-intensive research programmes in ways that were not previously possible.
Intelligent workflow automation: By automating routine tasks and complete processes, CROs can focus on more complex and value-added activities, enhancing their overall research capabilities and continuing the journey to becoming R&D leaders.
AI accelerates production workflows
Naturally, AI is a hot topic, as it is already demonstrating the ability to analyse very large datasets in near-real time. The resulting comprehensive view enables researchers to make faster, better-informed decisions, transforming a traditionally lengthy process.
Moreover, AI’s ability to manage big data at scale is unparalleled, and excels at recognising intricate patterns that may be difficult for human researchers to detect. Similarly, AI learning capabilities can greatly accelerate workflows, by automating repetitive tasks such as moving, copying and categorising data, or recommending and setting optimised assay parameters.
AI analysis may highlight new opportunities, and suggest amendments to processes and workflows to produce improved efficiency. By reducing the administrative workload and improving data management capabilities, assistance from AI tools can help to deliver products to market earlier.
Aligning with regulatory compliance
With many new techniques and modalities coming rapidly to market, the pharmaceutical industry is facing additional regulatory complexity, with strict requirements for drug development and clinical trial conduct.
For example, the cybersecurity framework global security guidelines, published by the National Institute of Standards and Technology (NIST) in the U.S., are frequently revised and updated. Similarly, the System and Organisation Controls guidelines, more commonly known as SOC2 published by the American Institute of Certified Public Accountants (AICPA), are effectively a global security standard. In a complex, interconnected world, the only realistic approach to maintain currency with regulations is to deploy automated systems that are always up-to-date, an approach which will help to build trust with partner organisations.
As CROs provide essential support in navigating the complexities of drug development, it is increasingly vital to ensure robust processes that conform with regulators’ demands, from biosafety to data security. A full-service CRO in India needs to possess comprehensive knowledge of the intricacies of both Indian and global requirements, ensuring meticulous preparation of submissions and compliance with regulatory standards.
As an example of a pharmaceutical and CRO partnership, SK Life Science Labs (speaking at the Revvity Signals NEXUS Conference), shared how the company collaborates with more than 40 CROs using its cloud-based electronic lab notebook (ELN). The ELN enables SK Life Science Labs to provide controlled access to secure workspaces for the CROs to record experimental data, allowing in-house chemists to check the CROs’ work in real time. SK Life Science Labs found that integrating this technology significantly streamlined partner relationships while increasing traceability, improving inventory management, and boosting productivity.
Similarly, pharmaceutical company Nimbus Therapeutics employs a distributed research model that leverages a network of strategic CRO partnerships to accelerate drug discovery. Nimbus Therapeutics uses software to provide data visualisation that highlights process bottlenecks. Armed with clear identification of the issues, Nimbus Therapeutics reports that it optimised its research model and accelerated drug discovery by cutting the typical data upload time to just two days, reducing manual data interventions by half, and increasing screening throughput by 50 per cent.
Tomorrow’s CRO landscape in India
Technology and global collaboration are reshaping the role of CROs in drug discovery. Since the early 1980s, CROs have expanded from preclinical testing to areas such as clinical trials, data management, pharmacovigilance and logistics.
Remaining competitive in this very active Indian growth market depends on continuous process innovation and proactive client engagement. CROs capable of leveraging AI and machine learning to support virtual screening, lead optimisation, and identification of novel drug candidates will be at the forefront of drug discovery in terms of efficiency and productivity. In addition, the ability to screen large compound libraries quickly and cost-effectively through automation, and the capacity to analyse and interpret complex datasets, will help CROs develop high-value-added services such as target identification, lead optimisation, and candidate development.
By investing in digital transformation, CROs can enhance their research capabilities, improve efficiency, and reduce costs. Advanced software solutions are playing a crucial role in this transformation, enabling CROs to manage complex datasets, ensure regulatory compliance, and collaborate effectively with global partners.
CROs are a substantial growth market in India, providing a vital service to global pharmaceutical companies. To maintain their edge, CROs must continue to grow their technological capabilities, increasing efficiency, improving regulatory compliance, and enhancing data security through the strategic use of new technologies and enhanced software solutions. CROs that can offer these benefits will be at the vanguard of the drug discovery collaborations of the future.
The software industry continues to enhance its solutions, and the best of these are now integrating generative AI and science-based AI models into the workflow. With AI tools, scientists can work more effectively, advancing projects faster and enhancing productivity. By accelerating timelines and improving data quality, an integrated approach to AI will help to bring products to market faster, and set new standards in process efficiency.
While technology is an enabler of great things, international collaboration depends on cultural and organisational integration, too. On-site visits to demonstrate capacity and capability play an essential role in building global teams, helping all stakeholders to learn how to collaborate and thrive as global partners.
As the industry continues to evolve, the role of digital platforms in shaping the next era of research will become more significant. Indian CROs that embrace these technologies and open their arms to partnerships are well-positioned to lead the way in global pharmaceutical R&D, driving innovation and delivering world-beating research services.
Footnotes:
1 https://www.marketresearchfuture.com/reports/india-cromarket-2927
2 https://www.gminsights.com/industry-analysis/contractresearch-organization-cro-market
3 https://www.grandviewresearch.com/horizon/outlook/ laboratory-information-management-system-market/india
Author Bio
Chris Stumpf is a Senior Principal Marketing Professional responsible for Marketing Programs at Revvity Signals. Chris has over 20 years of experience in the Analytical Instrumentation and Informatics industry spanning Pharmaceuticals & Life Sciences to Chemicals & Materials. He has a Ph.D. in Analytical Chemistry and Mass Spectrometry from Purdue University.
