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Clinical Trial

08-06-2014
Clinical TrialClinical Trial
Clinical TrialClinical Trial
A clinical trial  is an empirical assesment of a drug through its direct administration or application in human beings. Therefore, it is of paramount importance that all parties engaged in conducting a clinical trial, such as BioClever, have the appropriate quality and guarantee certifications. Your projects deserve to be conducted by our trusted and dedicated team of professionals.

In the pharmaceutical industry, it is common to outsource the different phases of a clinical trial to a CROs such as BioClever.

Our organization offers to conduct phases II-IV of all sorts of clinical trials, except for Phase I trials, which require administering a drug that has not yet been tested on human beings.

Phases of a clinical trial

Thus, at BioClever , we can design and develop the following phases of a clinical trial: 

  • Phase I (not conducted by BioClever). At this stage of the trial, the safety of a new drug is verified by administering it to human beings. 
  • Phase II. This phase provides preliminary information about the efficacy of the drug and establishes the dose-response relationship.
  • Phase III. Phase of the clinical trial that assesses the efficacy and safety of the experimental treatment in use conditions that are considered common.
  • Phase IV. Phase of the trial that is conducted when the drug has already been marketed and that seeks to learn more about it. 
Thus, at BioClever, we have a highly qualified professional team to conduct any phase of a clinical trial with the maximum assurance of professionalism and quality provided by our many years of experience in the sector, always meeting our clients' needs. 

Related news

Regulations concerning clinical trials with drug products
20-11-2016

Regulations concerning clinical trials with drug products

At the 11th Congress held by the Medical Association of the Pharmaceutical Industry (AMIFE, as per the Spanish acronym), held on November 12-14 in Madrid, one of the issues discussed was the status of the Clinical Trial Royal Decree, which is currently awaiting the ruling of the State Council, since the text is almost finished, as stated by Mr. César Hernández, Head of the Committee on Medicinal Products for Human Use of the Spanish Agency of Medicinal Products and Medical Devices (AEMPS).
New Royal Decree Analyzed in 'Conference on Clinical Trials.'
20-09-2017

New Royal Decree Analyzed in 'Conference on Clinical Trials.'

Several issues of the new legislation regulating clinical trials and studies started by investigators have been explored from a practical approach during the ‘Conference on Clinical Trials’ organized by the European University and BioClever.