CRO vs. Sponsor, An Overview about Differences

The process of clinical research is intricate and crucial, involving multiple parties to ensure the prompt delivery of optimal investigational treatments to patients.

The process of clinical research is intricate and crucial, involving multiple parties to ensure the prompt delivery of optimal investigational treatments to patients. Following disruptions caused by COVID-19 in 2020, there has been a steady rise in industry-sponsored trials since 2021 and an increase in demand for partnership with contract research organizations (CROs).

Clinical research relies on the collaboration of both sponsor companies and CROs to achieve success. However, there are distinct contrasts between these two entities that underscore their indispensable partnership in clinical trials. In this article, we will examine five critical disparities separating sponsors from CROs.

There are 5 significant distinctions between a sponsor and a CRO

1. Distinction among roles in Clinical Trials

Although they are both crucial to the prosperous implementation of clinical trials, sponsors and CROs have separate responsibilities in clinical research. The sponsor is responsible for providing funding, direction, and general supervision while a CRO provides specific services that aid in streamlining trial operations.

Sponsor

Ownership and Accountability: Sponsors are generally organizations such as pharmaceutical companies, academic institutions, or government agencies that establish and finance clinical trials. They assume complete ownership and accountability for the trial’s structure, implementation, and results.

Regulatory Standards: To comply with regulations and ethical standards, sponsors must ensure that the trial adheres to them. Furthermore, they are responsible for submitting both the protocol and results of said trial to regulatory authorities.

Financial Supervision: Sponsors are responsible for the financial oversight required to conduct the trial, which includes funding site fees, compensating investigators and covering drug manufacturing expenses.

Power of Decision: Sponsors hold ultimate decision-making authority for critical decisions such as trial design, site selection and determining whether a trial should be terminated or continued.

CRO

Outsourced Assistance: CROs, or Contract Research Organizations, offer outsourced services to sponsors for various tasks involved in clinical trials such as patient recruitment, statistical analysis, and data management. They are external organizations hired by the sponsor for this purpose. Site management is another service that CROs may provide during a clinical trial.

Operational Competence: When it comes to conducting clinical trials effectively and in accordance with regulatory guidelines, CROs offer a deep well of specialized expertise. These organizations can take on many different tasks, from identifying optimal study sites and recruiting patients to monitoring studies, managing data sets, and performing statistical analyses.

Risk Reduction: Ultimately, their goal is always the same: To ensure that your trial runs as smoothly as possible while adhering strictly to industry standards for safety and efficacy alike. Sponsors frequently turn to CROs for risk reduction in trial management, given the latter’s expertise in navigating the intricacies of clinical research.

Cost-effectiveness and efficiency: CROs can optimize trial processes, resulting in lower costs and faster timelines for completion

2. Variances in Competencies

Many sponsor-CRO partnerships are founded on the differing levels of expertise between the parties involved. By entrusting clinical trial professionals and operational support to a CRO with prior experience, sponsors can allocate their time and resources towards R&D investments for future innovations.

Specialty on the Sponsor

Therapeutic: Sponsors usually have a comprehensive understanding of the therapeutic category in which they are conducting trials for their product. They possess extensive knowledge about the scientific aspects and potential clinical implications associated with the drug or treatment.

Product Development: The development of the investigational product, including pre-clinical research, formulation and manufacturing falls under the responsibility of sponsors.

Specialty on CRO

Operational Competencies: CROs possess specialized operational knowledge of clinical trials. They have tailored infrastructure intended for efficient processes, systems, and technologies essential to carry out successful clinical research. With their prowess in the field, CROs display exceptional proficiency towards site selection procedures; patient recruitment techniques which include data collection capabilities as well regulatory compliance practices necessary for a proficiently always conducted trial study.

Clinical Trial: CROs possess considerable clinical trial experience, having worked on diverse trials across various therapeutic domains. As a result, they have an extensive understanding of managing trials from a broader standpoint.

3. Financial Responsibility Differences

Sponsor

Sponsors are responsible for supplying financial resources that cover the direct and indirect expenses linked with conducting the entire clinical trial.

Sponsorship entails financial accountability for the triumph of the trial, given that sponsors bear responsibility for shouldering its economic weight.

CRO

Service Fee: CROs levy charges for the services they offer. The expenses can fluctuate based on the extent and intricacy of the mandatory provisions, which will be settled beforehand in accordance with the pricing framework favored by CRO.

Shared Responsibility: While the sponsor carries most of the financial responsibility for the trial, CROs are obligated to furnish services to adhering within a pre-arranged budget. Should they propose a fixed-rate pricing structure, they may assume some accountability and venture into shared risk.

4. Contrasts between Oversight and Management

Clinical trials entail distinct levels of oversight and management responsibilities for sponsors and CROs.

Sponsor

Trial Oversight: Trial oversight is the responsibility of sponsors, who make crucial decisions and ensure the clinical trial adheres to its predetermined protocol. Nevertheless, many operational duties on a daily basis are often delegated by them to CROs.

Project Management: The management of the project team, which encompasses both internal employees and external vendors, is frequently handled by sponsors in Project Management.

CRO

Operational Management: Day-to-day management of the trial, such as site monitoring, data handling and ensuring compliance with protocols, regulatory requirements and GCP guidelines fall under the responsibility of CROs in operational management.

Vendor Management: CROs can involve and oversee subcontractors or vendors who specialize in numerous services.

Responsibility of Managing Clinical Sites: As part of their duties, CROs oversee the study team which includes clinical research site coordinators, data managers and monitors. This relieves sponsor companies from handling operational matters allowing them to concentrate on the trial’s clinical aspects.

5. Different Regulatory Responsibilities

In clinical trials, the regulatory requirement responsibilities between a sponsor and a CRO differ significantly as their final key distinction.

Sponsors:

Regulatory Submissions: Sponsors bear the responsibility of creating and submitting regulatory submissions, which include clinical trial protocols as well as documents for regulation such as New Drug Applications (NDAs) or Investigational New Drug (IND) applications. These must be provided to participating countries’ respective regulatory authorities.

Safety Reporting: Sponsors bear responsibility for the triumph of the investigation and must guarantee that it proceeds in an ethical and secure manner. They are obliged to transmit safety data and adversarial occurrences to regulatory agencies as prescribed by pertinent regulations.

CROs

Supportive Role: CROs play a supportive role in helping sponsors with the preparation and upkeep of regulatory documentation, but they usually do not submit these documents directly to regulatory agencies.

Regulatory Submissions: CROs must abide by GCP guidelines and other regulatory obligations regarding the submission of documentation related to trials, but they do not carry out direct responsibility for submitting such documents to relevant authorities.

Safety Data Collection: CROs may be involved in the gathering and overseeing of safety data, but they relay such information to the sponsor for regulatory purposes.

The partnership between sponsors and CROs is decisive

Comprehending the contrasts between CROs and Sponsors in clinical trials is imperative since their obligations, domains of proficiency, and regulatory requisites differ significantly. With this understanding, sponsors and CROs can collaborate towards efficacious clinical trials to facilitate advantageous treatment options for patients.

Over time, the intricacies of clinical trials and regulatory protocols have grown increasingly intricate. Consequently, a partnership between sponsors and CROs fosters cooperative collaboration that promotes timely and cost-effective execution of new studies.

Such teamwork ultimately contributes to improved patient outcomes in shorter durations while propelling progress in critical areas of medical research.

Partner with Milo, a full global CRO provider

Milo Healthcare is a tech-forward CRO of the next generation, offering faster and more efficient trials with significantly reduced costs to biotech sponsors. Our versatile teams provide full-service solutions across nine therapeutic areas such as oncology, dermatology, digital therapeutics, medical devices and rare diseases, among others.

Through the collaboration of pioneers, engineers and ClinOps leaders, we’ve created a comprehensive CRO that employs seamless end-to-end technology on a global scale. Our mission aims to enhance scientists’ capabilities while enriching people’s lives with happiness and good health.

For more information on how we are restructuring the relationship between sponsors and CROs, while making the clinical trial process simpler, please visit Milo website and get in touch with one of our team members today!