What is CRO

A cro is a clinical research organization by contract. It is a type of company that offers its clinical studies management services to the pharmaceutical, biotechnology, and medical device manufacturers mainly. The management of a clinical study is more complicated than it might seem since many actors are involved (manufacturers, promoters, ethical committees, competent authorities, Centers, Foundations, Researchers, legal departments, patients). Also, they must work under the rules of Good Clinical Practice and the Harmonization Guidelines (GCP-ICH Guidelines) that ensure the quality of the study. Being able to have a CRO as a partner to rely on the management of the study is essential and in this case, the clinical research organization by contract acts as a bridge between the promoter, the one who hires the services, and the rest of the actors involved in the clinical study.

clinical research organization

Services offered by a CRO:

Traditionally, CROs have been responsible for the implementation and monitoring of clinical trials, but more and more companies that offer all the services associated with conducting a clinical study are considered “full-service CROs.” The services that a CRO can offer can be divided according to the phase in which you are in the study:

clinical research organization
  • The implementation includes the development and review of protocols for trials, the adaptation of the necessary documentation to the legislation, the obtaining of the necessary approvals from the clinical research ethics committees and regulatory authorities, the design and the preparation of the data collection notebooks, the determination of the sample, the selection of the best researchers and research centers and the final negotiation of the contracts.
  • Once approval is approved and the trial begins, the clinical research organization by contract offers its services for monitoring, which consists of monitoring compliance with the protocol and with the procedures established for the development of the study. Likewise, pharmacy vigilance services include detection and action in case of the occurrence of an Adverse Event.
  • The last steps to ensure the success of any clinical study are the management of data, the generation of reports and the control and storage of documentation. Throughout the study, work is carried out by Good Clinical Practices (BPC) that ensures the quality of the study.

 Types of CROs

There are different criteria to classify CROs:

  • If you take into account the level of specialization of the company, you can find companies specialized in a type of study (clinical trials, research with health products or observational studies) and also CROs specialized in a therapeutic area, such as oncology or ophthalmology.
  • Taking into account the geographical area in which they move, you can classify CROs as local or global. Global companies are usually large companies that have offices all over the world, their coverage is greater, but they are usually less flexible than local ones, whose knowledge of the country’s peculiarities is greater, but their coverage is usually not as wide.

One Response

  1. This is EXACTLY what they have done to us,,ie CPP,,,there is NO MONEY for research for us,,to prove our doctors original treatment for CPP’s using the MEDICINE opiates worked,,,,Exactly what their gonna try to do w.mmj,,,cut the funding for any research,,,,THIS GOVERNMENT IS CORRUPT FOLKS,,,,BIG TIME,,,,ON OUR DIME… it need to be ABOLISHED AND NEW GUARDS put in to get it back to what our founding fathers fought and died for,,,They’d be shocked that the D.O.I. its not conscider’d law of the land legally.,,,,In there time,,,,ALL OUR type of MEDICINE WAS LEGAL,,AND NO DOC’S NEEDED TO GET MEDICINE to relieve physical pain,,Heck Thomas Jefferson grew his own pain medicine,,ie,,poppy flowers,,,,,So jmo,,,,its going to keep being like this until ,”we the people,”’ do something about it,,,,Stop giving them money for their cushy insurance,retirement,pay,,,,via NO MORE TAXES,,, i dont know just thinken out loud,,,but they are doing this obviously on purpose,,I mean what is the big deal about pot,,,for adults,,,there is none,,,,other than a paycheck for the dea,,,,,jmo,,maryw

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