In 2022, the global market size for contract research organization (CRO) services was US$73.38 billion, a value that is projected to increase at a compound annual growth rate (CAGR) of 12.5% from 2023-2030 and reach US$188.52 billion by the end of the decade.  

This is in line with recent trends in R&D spending; a study published in October 2023 from the St Gallen Consortium revealed that companies have raised their R&D spending at a CAGR of 6%, reaching an average R&D expenditure of $6.7 billion per company by 2020. Such significant investments in R&D programs are typically accompanied with greater time and cost constraints for pharma sponsors, driving a growing preference for outsourcing to CROs.  

 

What is a Contract Research Organization (CRO)? 

A CRO is a third-party company with unique specialized expertise in supporting R&D processes for sponsors, typically by providing clinical trial services. These services can vary between the pharmaceutical, biotechnology, and medical device industries. However, to streamline the journey from a mere concept to a market-ready product, there are key offerings sponsors should look for when choosing the right CRO. 

Read on to find out the top ten services commonly provided by the world’s leading CROs and why they are must-haves for sponsors conducting clinical research.  

 

Top Ten Must-Have CRO Services 

 

 1. Project Management by CROs

Project management involves meticulous planning, organization, and supervision of various projects, ensuring that they are completed within the agreed upon timeline and budget. Drug discovery and development is undoubtedly an expensive undertaking for researchers and sponsors. Therefore, CROs with the best value will offer efficient and transparent project management solutions. A CRO with robust clinical project management capabilities can provide invaluable support to drive success throughout a product’s lifecycle by ensuring optimal resource allocation, risk management, and timely accomplishment of project goals. At TFS HealthScience, we leverage our successful customer partnerships, based on trust and commitment, to provide project management support to programs that require specific expertise and swift responses.  

 

2. CRO-Managed Clinical Trials

Clinical trials are among the most traditional of the services provided by the world’s leading CROs. These trials involve testing new drugs or therapies on human volunteers to determine the product’s safety and efficacy to obtain regulatory approval. However, increasing clinical trial complexity is one of the top emerging challenges faced by sponsors in today’s era of clinical research, as well as the accompanying rise in costs. A CRO with expertise in clinical trial monitoring and study management can provide pharma and biotech companies with the reassurance that their trials will be conducted with careful planning, precise execution, and thorough analysis, while maintaining excellent study integrity. Discover the five essential steps to follow when selecting the right CRO in our article here.  

 

3. Data Management Services

The primary objective of conducting clinical trials is to provide evidence-based research behind new drugs and interventions that have the potential to impact the quality of life of patients around the world. This objective is critically dependent on the integrity, security, and proper utilization of the data collected during these trials. Leading CROs provide sponsors access to their advanced technologies and large data management systems, which help streamline data collection, cleaning, validation, and storage. Real-time data management by these CRO services enable researchers to conduct timely analysis and informed decisions.  

 

4. Regulatory Affairs Expertise

Regulatory services are a fundamental responsibility of any CRO, consisting of regulatory consulting, document submission and approval, and liaising with regulatory authorities such as the United States Food and Drug Administration (FDA). Accordingly, leading CROs must be extensively familiar with various national, international, and ethical regulations and guidelines. Considering the increasing globalization of clinical trials, such expertise from a CRO makes conducting multinational trials a more feasible possibility, ensuring recruitment from diverse participant populations and improving their study’s generalizability. 

 

5. CRO-Supported Medical Writing

Medical writing involves creating well-structured, clear, and concise reports that effectively communicate research findings, specifically for regulatory submissions and publication in scientific journals. By outsourcing this critical service out to a well-equipped CRO, sponsors can ensure essential documents like clinical study protocols and investigator brochures are prepared successfully. In addition to savings in cost and resources with hiring medical writers for the task themselves, CROs with this service ensure trial companies adhere to regulatory guidelines and can translate complex trial data to be more comprehensible for a variety of audiences. 

 

6. Biostatistics Support

Appropriate application of statistical concepts in clinical trials plays a crucial role in ensuring the trial is adequately designed, as well as its results effectively analyzed and interpreted. Therefore, leading CROs will typically employ experts in the field of biostatistics and data analysis who can help sponsor companies generate insights and draw accurate conclusions from their trial data. CROs that exceed expectations with this service significantly enhance the reliability and applicability of the results of a clinical study. 

 

7. Quality Assurance Services

In accordance with the International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines, sponsors must ensure they have systems and procedures which work to maintain the quality of their clinical trials. Although this responsibility ultimately falls on the part of the sponsor conducting the study, the CRO is also required to implement quality assurance and quality control measures on their end. Some examples of this service can include conducting internal audits, developing standard operating procedures (SOPs), and providing training to research staff. Properly executed quality assurance protocols help ensure trials are conducted according to the protocol to maintain patient safety and improve the chances of approval from regulatory bodies.  

 

8. Pharmacovigilance Support

Another essential service offered by leading CROs is pharmacovigilance, which involves the detection, assessment, understanding, and prevention of adverse events associated with investigational drugs. Pharmacovigilance teams are responsible for identifying and assessing potential adverse events experienced by trial participants. Therefore, they play a crucial role in improving patient safety and informing effective real-world use of investigational therapies. Learn more about how TFS navigated the complexities of setting up a post-marketing Pharmacovigilance (PV) system in this case study here.  

 

9. Laboratory Services

Although not all companies will offer this service, some of the largest CROs in the world do provide additional central laboratory support for clinical trials. This can include a variety of testing that the sponsor may require participant samples to undergo in their protocol, such as clinical core laboratory testing, immunochemistry for biologics, biomarkers, and more. The expertise, expenses, and advanced technology required for accurate laboratory testing makes it so that sponsors will often outsource this service out to an experienced CRO. As a result, they receive accurate, reliable, and timely testing of patient samples, which then contributes to the successful collection of data within a clinical trial. 

 

10. CRO Consulting Services

Lastly, leading CROs will often provide consulting services to sponsors, whether in conjunction with the other services previously discussed or as a standalone offer. Such services entail providing advice to their clients on optimal strategies for conducting a clinical trial efficiently and increasing the chances of regulatory approval. Examples may include providing input on the study design, contributing to the trial protocol, and navigating common recruitment challenges by designing effective study campaigns. CROs are built on their team of clinical research experts who have an in-depth knowledge of the drug development industry; as such, their guidance can help sponsors navigate complexities of the clinical trial landscape and successfully meet their research goals.  

 

Conclusion

In conclusion, sponsors can benefit from a wide range of must-have services provided by the world’s leading CROs. From project management to consulting, these top ten services cater to every stage of the R&D process of developing and conducting a successful clinical trial. CROs are a vital component of the pharmaceutical industry, having played a significant role in the industry’s success in recent years and helping bring innovative solutions more quickly to the patients who need them. These organizations may have started out as useful resources for pharmaceutical companies, but today, their wide breadth of experience also makes CROs an essential partner in the drug development process.  

 

About TFS HealthScience CRO 

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. As a trusted CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline clinical trials for our clients. 

Visit our website to learn more about the solutions TFS can offer for your next clinical trial or connect with a TFS representative today!