What is a Clinical Research Organization (CRO)?

A Contract Research Organization (CRO), also known as a clinical research organization, is an organization hired by another company to take the lead in managing trials and that company's complex responsibilities for complex medical tests. A CRO acts as a bridge between the sponsor, the person who contracts the services, and the rest of the actors participating in the clinical trial. A CRO is contracted by a pharmaceutical, biotechnology or related entity to manage and direct its clinical trials. However, there are times, during the development and post-marketing phases, when pharmaceutical and device companies detect the need to contract services, when there are shortages in internal resources to meet milestones, or when the decision is made to outsource key services instead of creating an internal team. Today, the companies that are outsourced are called Contract Research Organizations (CROs), a sector with a rich history.

One of the first CROs was Charles River Laboratories. According to their website, “in 1947, a young veterinarian bought a thousand rat cages on a Virginia farm and established a one-man laboratory in Boston, overlooking the Charles River. In an effort to meet the regional need for laboratory animal models, he raised, fed and cared for the animals and personally delivered them to local researchers.” The rest is history. A CRO provides clinical trial services for the pharmaceutical, biotechnology and medical device industries. Monitoring clinical trials helps ensure that the trial is conducted, recorded and reported in accordance with the protocol, ethics committees and good clinical practices (BCP).

By choosing a CRO committed to operational excellence, customers gain more than clinical trial capabilities: they secure a valued partner with a shared commitment to the success of their clinical program. We create comprehensive but efficient monitoring plans to manage clinical trials and build trust in the integrity of clinical trials. The MED Institute is a full-service CRO with more than 35 years of experience in designing and executing clinical trials, ranging from initial feasibility studies to multinational controlled fundamental trials and post-market registrations. Outsourcing clinical trials to companies that organize clinical trials is a way to significantly reduce costs and compensate for the money they have to give up because of lower drug prices.

Types of Contract Research Organizations

There are different types of CROs, but typical CRO services in the medical device sector include regulatory matters, clinical trial planning, center selection and initiation, hiring support, clinical monitoring, data management, trial logistics, biostatistics, medical writing, and project management.

Benefits of Clinical Monitoring

Active clinical monitoring can help to predict potential problems that may arise in clinical trials or, at least, to identify problems at an early stage so that they can be addressed before significant delays occur, translate into increased costs or completely derail the trial.

Planning Clinical Trials

Planning clinical trials and starting studies include the process of creating the clinical plan and clinical protocol and obtaining the necessary approvals from regulatory authorities and ethics committees. It is estimated that nearly three out of four clinical trials are carried out by Contract Research Organizations (CROs), demonstrating to what extent sponsors value and trust the work they do.

While the sponsoring company transfers the functions of the trial to a CRO company, the sponsor is responsible for the integrity of the trial and must ensure that the results are supported by facts and scientists.