Clinical research consultant -Making Your Clinical Trail Easy
A clinical trial from the moment you start planning until you have the final report with the results, its interpretation, and the conclusions have passed many situations and actions that have required decision-making, some easy, others not so easy. There are a number of key moments in the clinical trial, such as writing the protocol, selecting the investigators, recruiting the patients, closing the database, and knowing the results in the statistical report.
Managing a clinical trial is fraught with difficulties and unforeseen events. There are national and international legislation and guidelines that must be followed and applied that make it more complex and specialized.
Role of Clinical research consultant
There is a Clinical research consultant who participates at throughout the clinical trial process, such as manufacturers, promoters, ethical committees, competent authorities, health centers, foundations, researchers, legal departments, and patients.
Although all clinical trial topics are thought to be controlled, and a contingency plan has been made, unforeseen issues always appear that affect the study, and decisions must be made. There have not been any clinical trials that have not appeared unforeseen in our professional stage. Since a researcher-made fraud with the inclusion of patients that did not exist, all the data were invented until a researcher certified that he had performed a microbiological culture on each patient, and it was a lie. He hadn’t done it to anyone. These two cases are extreme. On the opposite side, most researchers follow the protocol and comply with all current regulations.
The Clinical research consultant of Healthcare Products should be a specialized and independent advisory service that Healthcare Products companies use to find a valid interlocutor to manage the clinical trial. Clinical trial must be carried out according to the European Regulation or also just an advisory service on which is the best clinical trial proposal to obtain the CE mark.
The advice of the Clinical research consultants must be based on innovation, experience, knowledge, and skills of the professionals.
To carry out a clinical trial, it is necessary to “outsourcing” that is, to outsource all its management with the use of a CRO that is a Contract Research Organization, which is a company that acts as a bridge between the promoter (Sanitary Products company), the one that contracts the services, and the rest of the actors involved in the clinical study, assuming various technical and administrative responsibilities on behalf of the promoter. The CROs have become essential because they have the “Know-How” of all the clinical trial activities.
