As COVID-19 swept the U.S., Meridian began enrolling people for vaccine trials at sites nationwide. We frequently heard the same questions: Which vaccine is this trial for? Is it one Meridian is creating? Can I join the trial for the Moderna, Pfizer/BioNTech, Novavax, etc. vaccine?
One silver lining of the pandemic (if there can be such a thing) is that more people became interested in the vaccine research and development process. It often surprised newcomers to hear that Meridian doesn’t actually create new vaccines or products. Instead, Meridian conducts clinical trials at its sites to help other companies (Sponsors) research and develop their products.
Here’s a quick summary of the companies at the core of clinical trials.
The organizations that fund the research and development of new products are called Sponsors. A sponsor can be a large, global company (e.g., Pfizer, Moderna), a small biotech startup, or even a government agency. In the case of the recent COVID-19 vaccines, Moderna and Pfizer/BioNTech were Sponsors of their respective vaccine development programs.
Most Sponsors focus on discovering new products and deciding which products may be viable candidates for development. But before a product can be sold commercially in the U.S., it has to be approved by the Food and Drug Administration (FDA) based on clinical safety and efficacy data. Clinical trials are the only way to generate that data.
Contract Research Organizations (CROs)
The clinical trial process can be a long, complex journey. Some Sponsors manage their own clinical trials directly, but the majority of Sponsors — large and small — partner with contract/clinical research organizations (CROs) to facilitate that journey.
Typically, CROs start by helping a Sponsor develop a clinical trial protocol. The protocol outlines a clinical trial’s objectives, study design, patient population, investigational product, statistical methodology, and more. In essence, the protocol is a comprehensive plan to help researchers collect and analyze accurate data, all while safeguarding patients.
The data gathered helps scientists, statisticians, and regulators determine how safe and effective a product is, and whether or not it should progress through clinical trial phases and be approved to be sold in the commercial market.
To carry out the protocol, Sponsors and CROs identify sites at which to conduct studies (and support or provide services for data management, monitoring, quality assurance, regulatory submissions, etc.).
This is where we come in — Meridian maintains a nationwide network of clinical research sites.
A clinical research site is a location at which clinical trials are conducted. Participants visit these sites to enroll in trials and, potentially, receive an investigational product.
More Companies May Be Involved
In short, Sponsors fund the research and development of investigational products, CROs help facilitate clinical trials, ands sites conduct the actual studies by seeing patients and collecting data.
However, it can take more than a decade to develop a new drug, and the average development cost is estimated to be $2.6 billion1. Clinical trials alone often last for six or more years. It’s no wonder so many companies may be involved in the research and development of a single product.
Sponsors and CROs may manage the following services in house, or they may work with the following vendors to support key clinical trial objectives.
- Contract manufacturing organizations (CMOs): Manufacture and package the investigational product(s) being studied, help scale-up supplies for larger trials or commercialization
- Laboratories: Develop the investigational product, analyze specimens/samples
- Logistics managers: Ensure the safe, secure shipping and handling of investigational products, specimens, and/or other study-related materials
- Equipment vendors: Supply everything from laboratory and storage equipment (e.g., freezers, blood vials) to clinical materials (e.g., gloves, swabs)
- Regulatory consultants: Help Sponsors and CROs prepare and submit information for review by regulators (such as the FDA)
- Technology providers: Provide software to help parties collect, manage, analyze, and/or package data