Guest Column | August 23, 2023

Assessing Specialized Services Provided By CROs

By Oscar Segurado, MD, Ph.D., chief medical officer, ASC Therapeutics

Historically, a CRO’s main role has been to provide clinical trial site and data management. However, it also supports other specialized services essential to conduct a successful clinical development program. Beginning in 2017, clinical outsourcing occurred in approximately 50% of trials and has continued to increase.1 The standard list of CRO services now includes site selection and engagement, patient identification and enrollment, trial monitoring and compliance, and data monitoring and analysis.

With a growing demand for CRO services, these companies are developing competitive advantages and methods to increase efficiencies for clinical trials. Although many large CROs are offering end-to-end services, smaller, specialized CROs tend to offer more personalized solutions. At times, companies/institutions may even hire more than one CRO, those of which must collaborate to provide the appropriate services across the clinical trial timeline.

CROs That Specialize In A Therapeutic Area

Some CROs specialize in specific phases of clinical trials, certain therapeutic areas, such as oncology or central nervous system (CNS), or a particular industry. One particular oncology CRO advertises its intuitive platforms, allowing the capture of intelligent data and centralized monitoring. Another oncology focused CRO specializes in earlier phase trials and offers additional patient recruitment and retention resources. One CNS specialized CRO offers a personalized training academy for physicians and other staff who are new to research and another mainly assists in preclinical research and provides specialized laboratory services.

CROs That Focus On Patient Recruitment

When it comes to rare disease clinical trials, enrollment can be tricky due to their small recruitment pool; however, some specialty CROs have strategies to address this challenge. One such rare disease CRO offers expertise in recruitment from small patient populations and the ability to draw reasonable conclusions from limited data sets. In addition, it uses its “deep connections with advocacy groups” to assist in recruitment for difficult-to-reach and limited patient populations. Aside from the use of advocacy groups, these CROs come with ideas on how to reduce the patient burden of being part of a clinical trial, such as financially supporting travel and reducing the number of in-person visits to a minimum. CROs may also help with recruiting more diverse populations to enhance the generalizability of your study results.

CROs That Offer A Local, National, And Global Reach

When conducting clinical trials across multiple countries, your CRO must be knowledgeable in each country’s standards of care and regulatory requirements. CROs may have expertise in specific countries. In fact, some CROs offer feasibility check services, which determine the regulatory constraints and technical feasibility of a proposed study. Keep in mind that global companies tend to have country-based regulatory and technical teams focused on large trials and may be less flexible when a specialized approach for rare diseases is required. On the other hand, hiring several CROs, say one domestic and one with global capabilities, may be the optimal option for achieving local expertise, while keeping the flexibility that a smaller CRO provides. Decentralized clinical trials are becoming more popular as well, especially with more CROs providing solutions, such as mobile clinical services, for their particular needs.

CROs That Integrate The Latest Technology

Technological resources are being increasingly offered by CROs or specialized service providers, such as cloud sharing to increase convenience, simplify workflows, and automate processes. Many CROs are either acquiring or partnering with niche providers to create more patient-centric studies. An example is the acquisition of mobile clinical services by a CRO to offer study visits in patients’ homes. Furthermore, recent advances in data collection technologies are improving data collection efficiency and integrity, allowing the flexibility of remote data collection and even enhancing patient engagement.

CROs That Offer Additional Services

In addition to clinical trial services, some CROs provide specialized laboratory testing services, such as preclinical and clinical sample analysis. One such CRO offers immunochemistry, biomarker identification, peripheral blood mononuclear cell (PBMC) processing services, and even sample storage. Another provides preclinical safety assessment, which may include toxicology services or environmental safety assessments.

Other examples of specialized services include regulatory services for new drug application (NDA) and marketing authorization application (MAA) submissions, independent data monitoring committee services, protocol development, and post-marketing services. One also provides market intelligence and strategy consultation, and another provides solutions for diverse recruitment through investigator-community partnerships.

If you are an emerging biotech or a midsize biopharma, you might consider outsourcing to a CRO with specialized services in the development of patient-focused materials, such as educational materials and summaries of informed consent and study protocols, to reinforce your study enrollment efforts.

The varied expertise across CROs and their services highlights the importance of finding a CRO that can best provide services to meet and exceed your needs, while simultaneously improving the quality and speed of your preclinical or clinical research.‚Äč

References:

  1. https://www.clinicalleader.com/doc/analyzing-the-top-clinical trial-outsourcing-trends-of-0001

About The Author:

Oscar Segurado, MD, Ph.D., is an executive veteran with extensive global leadership experience in translational science, clinical development, and global regulatory and medical affairs. He is the chief medical officer for ASC Therapeutics, a fast-growing biotechnology company focused on developing curative gene- and cell-based therapies for rare blood disorders. Segurado is the author and co-author of over 100 peer-reviewed publications, including Nature and Lancet, books, and medical articles, as well as a member of several scientific and medical societies, including his role as a Forbes Council Board Member. He also holds a tenured Professorship of Immunology at the University of Leon, Spain. He received his Ph.D. from the University of Wuerzburg, Germany, and MD from the University of Salamanca, Spain.