A contract research organizations (CROs) is a third-party firm contracted by sponsors to deliver specialized services aimed at optimizing their research. The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits, including access to streamlined expertise and risk mitigation in clinical trials.

Nonetheless, while CROs play a pivotal role in streamlining operations and providing specialized expertise, sponsors continue to bear critical responsibilities throughout the clinical trial journey.

This article explores the roles of CROs and highlights strategic partnerships between CROs and external vendors, designed to enhance research outcomes. Additionally, the article discusses difficulties inherent in managing clinical trials and emphasizes the indispensable contributions of sponsors in the trial.

Breakdown of CROs Roles

Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management. However, their scope of services has significantly broadened, now covering the entire research process, from drug discovery to clinical trials and beyond.

Examples of services offered by CROs include:

• Study design and planning
• Site identification, selection, set-up, and management
• Regulatory affairs
• Project management
• Clinical monitoring
• Data management
• Logistics and clinical trial material management
• Quality assurance and compliance
• Medical writing
• Pharmacovigilance
• Biostatistics and statistical analysis

In order to provide these services, CROs enlist experts across various domains. These roles include project managers, research assistants, site contract managers, quality managers, clinical research associates, clinical trial assistants, regulatory affairs managers, heads of clinical operations, data managers, statistical programmers, and biostatisticians. Each role brings unique expertise and responsibilities, collectively upholding standards of efficiency, compliance, and quality within the sponsor’s operations, thus ensuring the smooth execution of research projects.

Do CROs Have to Outsource/Utilize Vendors?

While CROs offer a wide array of services, they frequently engage in outsourcing activities and partner with vendors to enhance their capabilities. These collaborations with external vendors are aimed at accessing specialized expertise, technologies, or resources that they may not have in-house.

Examples of vendors include:

• Laboratories: CROs often collaborate with specialized laboratories for various purposes, such as sample analysis or pharmacokinetic studies, among others. For example, Vial has recently announced a collaborative alliance with MLM Medical Labs to deliver high-quality and efficient central laboratory solutions
• Technology providers: CROs may partner with companies that offer specialized software platforms or technologies for data management, clinical trial management, biostatistics services, safety monitoring services, or electronic data capture. For instance, large CROs like PPD and IQVIA utilize multiple third-party vendors or SaaS partners for building out Electronic Data Capture (EDC) technology
• Clinical trial supplies and logistics: CROs often utilize vendors to procure clinical trial supplies such as investigational drugs, medical devices, and ancillary supplies. These vendors may also manage the entire supply chain logistics and provide distribution solutions. In June 2023, Vial has announced a strategic partnership with the Royale International Group, one of the largest independent logistics providers in the Asia Pacific region. This partnership aims to streamline the shipping process, guaranteeing the integrity and timely arrival of investigational products
• Site management organizations (SMOs): CROs may collaborate with SMOs to manage and coordinate operations at clinical trial sites.

Difficulties in Managing Clinical Trials

Managing clinical trials is a complex and demanding task that comes with its set of challenges. These challenges can significantly impact the success and efficiency of the research process. Importantly, they can change over time due to various external factors like evolving scientific knowledge, geopolitical instability, and public health emergencies, necessitating adaptation.

Common difficulties in managing clinical trials include:

·  Patient recruitment and retention: Recruiting and retaining a sufficient cohort of eligible participants is one of the major challenges in the execution of clinical trials. According to a survey conducted by PPD in 2022, patient recruitment emerged as the primary challenge for 55% of respondents, who also expressed concerns regarding retention and the diversity of patient populations.

·  Protocol adherence: Strict adherence to the study protocol by investigators and participants is key to obtain high-quality endpoint data. However, deviations from established protocols can occur. For instance, patient noncompliance compromises the integrity of the study results and may lead to inaccurate conclusions.

·  Regulatory compliance: Given the global and decentralized nature of clinical studies, involving various sites and stakeholders worldwide, adhering and staying compliant with evolving international, national, and local regulations becomes increasingly challenging. In 2018, a survey of pharmaceutical executives and professionals by ICON and Pharma Intelligence highlighted regulatory approval delays as a prevalent issue, pointed by 43% of respondents.

·  Data quality and management: Managing and analyzing the huge volume of data produced in a clinical trial often proves challenging. Challenges extend to data accessibility, interoperability, and security, necessitating robust measures for storage, verification, and compliance with regulatory standards.

·  Safety and adverse event management: Ensuring participant safety is paramount in clinical trials, necessitating robust safety monitoring systems such as adverse event reporting and risk assessment protocols. A recent survey-based study identified protocol discrepancies, inconsistent reporting practices, and challenges in interpreting adverse event definitions as common issues.

What Do Sponsors Still Have to Do, Even With a CRO on Board?

No doubt, having a CRO on board greatly facilitates the clinical trial process. However, even with a CRO on board, sponsors retain ownership and maintain responsibility for various aspects of the trial. Sponsors must possess in-depth therapeutic expertise and be prepared to make critical decisions while overseeing the entire trial process.

Here’s a breakdown of the sponsor’s ongoing responsibilities:

·  Protocol development: Sponsors spearhead the development of the clinical trial protocol, outlining its objectives, design, methodology, and statistical analysis plan

·  Regulatory Compliance: Sponsors are responsible for securing regulatory approval. This includes tasks such as submitting Investigational New Drug (IND) applications and obtaining Institutional Review Board (IRB) or Ethics Committee (EC) approval before trial initiation

·  Funding and budget management: Sponsors provide funding for the trial and manage its budgetary allocations to ensure smooth financial operations

·  Monitoring and oversight: Sponsors monitor trial progress, ensuring adherence to protocols, and oversee the activities of both the CRO and clinical sites

·  Safety reporting: Sponsors establish systems for collecting, reviewing, and reporting adverse events and safety issues to regulatory entities, implementing risk mitigation strategies as necessary

·  Data management: Sponsors take charge of managing the comprehensive lifecycle of trial data—from collection and storage to analysis—ensuring meticulous accuracy, security, and alignment with the statistical analysis plan outlined in the protocol

Conclusion

In conclusion, the role of CROs is crucial in optimizing research processes, yet sponsors maintain vital responsibilities throughout clinical trials. Understanding these roles, partnerships, and challenges ensures efficient collaboration and successful trial outcomes.

Vial: Your Full-Service CRO Partner

Vial stands as a next-generation, full-service CRO at the forefront of leveraging technology to accelerate clinical trials, leading to substantial time and cost efficiencies for sponsors. With our global reach and cutting-edge technology platform, we provide researchers with expert guidance and innovative solutions throughout the trial process.

To learn how Vial’s CRO can support your clinical trial, please visit our website or get in touch with a Vial representative today!