30 Years of Innovation in Drug Development: The Evolution of the Contract Research Organization

Since Altasciences arrived on the scene three decades ago, science and drug development have advanced significantly. 

Humble Beginnings: The Early Days and Adaptation of CROs 

CROs are nothing new. The origins of the current contract research organization (CRO) marketplace can be traced back to the 1940s and 1950s, with the emergence of companies like Huntingdon Life Sciences and Charles River Laboratories. As the costs of producing new drugs rose, sponsors began outsourcing more of their R&D, but the CRO industry as we recognize it today didn’t find its footing until the 1970s and 1980s when pioneering companies such as Quintiles (now part of IQVIA), and PPD, Inc. (now part of Thermo Fisher Scientific) expanded beyond preclinical testing into clinical trials, logistics, statistics, and data management.

By the late 1980s the industry was rapidly evolving. Blockbuster drugs like statins and selective serotonin reuptake inhibitors (SSRIs) were introduced to the market (both of which received approval in 1987). That surge in complex drug development prompted a growing reliance on CROs, with research and development (R&D) expenditures increasing from just 4% of total pharmaceutical budgets in the early 1990s, to nearly 50% by the mid-2000s.

Still, the market was not without growing pains. In the 1980s and into the early 1990s, many CROs primarily took on surplus work from sponsors running trials in-house, producing rapid swings between high demand and dry spells that constrained long-term growth. As Altasciences’ CEO Chris Perkin remembers, “Ever since the 70’s there were companies creating ‘me too generics’. CROs would handle overflow, and it was like the Wild West.”

The 1990s brought other turning points: the HIV/AIDS epidemic accelerated innovation and access to antiretroviral therapies, and oncology emerged as a dominant focus with targeted therapies and immunotherapies requiring more complex, personalized trial designs. Into the 2000s and especially the 2020s, pressures such as emerging infectious diseases and pandemic preparedness further increased demand for decentralized trials, adaptive protocols, and faster regulatory pathways.

CROs adapted by scaling infrastructure, embracing digital tools, and developing deeper expertise in specialized therapeutic areas, shifting from overflow vendors to strategic partners that provide innovation and operational strategy. They became essential for managing costs, timelines, and the operational complexity of larger, more geographically diverse trials. CROs have become critical partners in navigating increasingly complex pipelines and accelerating access to life-changing therapies, with the North American CRO services market alone valued at $85.54 billion USD as of 2024.

Altasciences: Breaking the Mold for Early-Phase Drug Development

As the role of the CRO shifted, they became more strategic and focused on long-term partnerships—almost as a branch of the clients’ team. In response to this evolution, Altasciences’ began shaping its future around the idea that early-phase drug development didn’t need to be fragmented across multiple vendors. “The idea of a single organization that could move a drug through all the early stages of development had been talked about for years,” Chris Perkin reflects. “I was inspired to transform this outsourcing paradigm, and that’s exactly what I set out to do with Altasciences.”

The traditional model often meant sponsors working with multiple CROs across preclinical and clinical stages, managing handoffs, data transfers, and methodological changes between organizations, a segmented approach that could be slow, error-prone, and costly.

Altasciences, however, was built to challenge this traditional model. Pivoting more than a decade ago from clinical testing of generics to supporting innovator drugs, we set out to simplify early-phase development from late discovery to clinical proof of concept, and beyond. By integrating preclinical research, Phase I and II clinical trials, bioanalysis, formulation and manufacturing, we built a holistic and integrated, end-to-end solution.

Scientific and operational teams collaborate across services and phases to enable real-time, data-driven decisions, streamlined study adjustments, and improved resource efficiency, paving a smoother path through each critical stage of development. What we presented to the market was an alternative: why contract with multiple CROs, when you could partner with just one for all of your early-phase drug development? 

A Shifting Talent Landscape in Drug Development

One notable, though often under-reported, trend reshaping the CRO landscape is the migration of top talent from traditional pharmaceutical roles into CROs. Many experienced scientists, heads of R&D, and former regulators have transitioned from the pharmaceutical sector to join CROs. As Marie-Hélène Raigneau, President at Altasciences, notes, “They are coming to us, seeing what we’re doing, and how we’re innovating, and wanting to be a part of that.”

This influx of seasoned professionals is not merely a shift in talent pools, but a strategic movement that amplifies the scientific capabilities and agility of CROs, validating them as strategic partners, with hands-on, expertise across multiple therapeutic areas.

Professionals from the pharmaceutical sector are increasingly attracted to the dynamic and innovative environment of CROs, where they can engage with a diverse range of therapies and modalities, and the flexibility to work across different functions and therapeutic areas offers significant career development opportunities. The fast-paced, innovation-driven culture of CROs also provides a platform for these professionals to continue to make an impact on the drug development process.

These professionals bring to CROs knowledge and experience acquired from being on the other side of drug development: the client perspective. “They have firsthand experience of all that goes into taking a drug through IND and all the way to NDA,” adds Steve Mason, Co-Chief Operating Officer at Altasciences. “And they can bring that insight to CROs to help other pharmaceutical and biopharmaceutical companies navigate those challenges.” 

Empowering Science with Artificial Intelligence

In June 2025, the FDA introduced Elsa, an agency-wide large language model (LLM) tool, which set a new precedent for the future of drug development. As North America’s most influential drug regulator, the FDA’s acknowledgment of the growing potential role of artificial intelligence (AI) in drug development reflects significant changes in the evolution of CROs.

Though Elsa is intended to help regulatory reviewers efficiently analyze and organize scientific material for more effective review workflows and faster decisions, it also has the potential to synthesize decades of clinical and preclinical data to inform predictive modeling, refine study design, introduce operational efficiencies, and supplement animal testing. 

Altasciences has been one such CRO that has delved into the benefits of AI in the drug development world, having recently partnered with Evidence Matters to contribute insights and lessons taken from 30 years of preclinical research across multiple drug classes, species, and therapeutic areas, creating a high-quality dataset to train their text engineering tool, RegulatoryFlow.

While current and former FDA officials have raised some concerns such as AI hallucinations or an overemphasis on findings that human reviewers might overlook or dismiss, experts see significant potential for this technology to ease the burden of repetitive tasks.

As Dr. Gaetano Morelli, MD, Chief Medical Officer of Altasciences, describes it, this represents a form of hybrid intelligence: “The term that's used out there is hybrid intelligence. … because computers and AI are obviously driven by algorithms, you’ve got to make sure that those algorithms don't have bias. It’ll really be a symbiotic thing. We can use AI to gather the data, organize it.” He concludes: “But then you still need that human touch, that human perspective. It’s that human judgment which AI really will not replace.”

Looking Ahead to Innovation, Integration, and Partnership

The landscape of drug development will naturally continue evolving, driven by breakthroughs in science and technology as well as the needs posed by complex conditions. As the growing prevalence of chronic, multifactorial conditions such as neurodegenerative diseases, rare genetic disorders, and cancers demand more tailored and efficient solutions, traditional clinical development models are giving way to more integrated and adaptive approaches.

Altasciences exemplifies how the CRO and CDMO industry is evolving from a transactional service provider to a strategic partner deeply embedded in sponsors’ drug development journeys, delivering rapid innovation while ensuring high-quality research and regulatory compliance. CROs are even taking a more active role in drug development strategies, according to Marie-Hélène, “We’re getting involved much earlier, asking the right questions, helping to co-design the drug development strategy for our clients… we’re even asking questions like, should we do this trial?”

This approach positions CROs not just as service providers but as strategic partners, helping sponsors to identify the most efficient and effective paths forward across multiple therapeutic areas and modalities. As an integrated CRO and CDMO, Altasciences has evolved with these shifts.

Throughout everything, though, Chris Perkin maintains a strong emphasis on our clients. “Many CROs lost the importance of the customer experience somewhere along the way,” Chris admits, stressing that “bureaucracy is typically a result of a company growing bigger, but we make our business decisions based on what is best for the clients that partner with us work with us… because in the end, they are the reason we exist.”

Reach out today to see how Altasciences’ 30 years of accumulated knowledge can help with your next study.

_{This blog was originally published in October 2025.}