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The Changing CRO Environment: Responding to New Models of Service Delivery and Change

By Dr. Diana L. Foster, CEO, Total Diversity Clinical Trial Management

Contract Research Organizations (CROs) are undergoing major changes driven by a variety of factors. Pressures in the field include compressed timelines, demands for greater efficiency and cost competitiveness, advances in technology, and a heightened emphasis on relationships with research sites and patients.

Emerging delivery models, such as Integrated Research Organizations (IROs), Functional Service Providers (FSPs), and Multisite Research Corporations, require a rethinking of traditional CRO structures. Whether large or small, Sponsors are increasingly requesting “fit for-purpose” service models that deviate significantly from the conventional CRO model.

The IRO, or Integrated Research Organization, is one such model that illustrates how Total Diversity, as a CRO, has adapted by blending critical CRO services with a more aggressive site-facing strategy and integrated technology, forming a unified approach. This model enables end-to-end accountability for trial performance, offering scalability and cost efficiency while maintaining high quality.

In response to this changing environment, Total Diversity has focused on growth, stability, and innovation. The company has prioritized developing and showcasing the following capabilities:

  • In-house sites and investigators
  • A focus on engaging sites with a track record of enrolling underrepresented populations
  • Integrated technology, including Resource Management Tools, CTMS, and Site

Dashboards

  • Patient recruitment and retention strategies that have resulted in 100% enrollment

targets met

  • Streamlined data reporting and operational oversight
  • An emphasis on relationship-building with sites and investigators
  • Expanded experience in emerging therapeutic areas such as dermatology, immunology,

ophthalmology, CNS, and cardiometabolic diseases

As a CRO, Total Diversity recognizes that sustainable, cost-effective vendor partnerships are essential to maintaining profitability. A recent acquisition has enabled Total to join a new family of companies that collectively provide the capabilities described above under one roof.

This expansion has significantly enhanced the CRO’s ability to meet evolving Sponsor expectations. The following organizations now make up this collaborative family of companies: Total Diversity Clinical Trial Management

Based in Dallas, Total Diversity is a full-service CRO with over 15 years of experience.

The company has a strong reputation for excellence in operations, quality, and on-time delivery.

Total Diversity also offers flexible commercial models tailored to client funding structures, ensuring budgets align with financing timelines and sources.

OrciMed Life Sciences

With approximately 400 staff across India and Manila, OrciMed operates globally, offering cost-efficient support across functions such as data entry, medical writing, and clinical trial operations. OrciMed is an ideal partner for Sponsors seeking to scale their operations without compromising quality.

SiteBridge

SiteBridge manages a proprietary network of about 100 clinical trial sites, many of which are new to research. The company uses electronic health record (EHR) integration to support patient identification and recruitment modeling. SiteBridge specializes in activating community based and underrepresented research sites, expanding access to clinical trials in diverse populations.

Intrinsic Systems

Intrinsic Systems delivers tailored technology solutions for clinical trials. Their offerings include Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and Resource Management (RM) platforms. These systems are intuitive and scalable, meeting the needs of both mid-market and enterprise-level clients. In a landscape long dominated by large global CROs, Sponsor and biotechnology company needs continue to evolve. Increasingly, end-to-end services are delivered by integrated networks of multiple providers, managed under a single CRO umbrella. Additionally, building close partnerships with Multisite Research Corporations has led to improvements in cost efficiency, faster enrollment timelines, and streamlined contracting.

For Total Diversity, interacting with research sites in this evolving environment has been one of the most exciting developments. As a CRO, Total benefits from the ability to form partnerships quickly and with less bureaucracy. Collaborations with organizations like Velocity Clinical Research have enabled Total to bring sites onboard rapidly and cost-effectively. Likewise, working with SiteBridge has created a one-stop destination for engaging underrepresented sites, offering unprecedented advantages in site access and enrollment. Over the past five years, the industry has seen a marked shift in focus, not only toward patient engagement but also in strengthening site relationships. Sites are finally gaining traction in addressing long-standing technology challenges, such as navigating multiple systems and providers, and in adopting tools to support internal resource management. Within this new structure, Intrinsic Clinical Systems offers capabilities that even large pharmaceutical companies often lack, supporting better resource planning and execution at the site level. These tools are especially important for enhancing operational efficiency in trials that demand both scale and adaptability.

In conclusion, the CRO environment is being reshaped by a convergence of technological, economic, regulatory, and clinical forces. CROs are no longer viewed merely as outsourcing vendors; instead, they are emerging as strategic partners in clinical research. This evolution presents opportunities for innovation, integration, and acceleration of drug development, ultimately improving how quickly and effectively treatments reach the patients who need them most.

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