Observational Studies

Observational StudiesObservational Studies
Observational StudiesObservational Studies
At BioClever, beyond just doing Phase II-IV clinical trials, we are very much involved in conducting observational studies.In this type of clinical research, the treatment is not the primary study objective, the observation of patientsis what matters the most. We are offering you the possibility of designing and conducting both descriptive and analytical observational studies. 

 Observational studies allow to generalize results to a given geographical and demographical population, besides helping answer more specific questions, since the patients included in the study usually go through rigorous screening; on the other hand, they also have some disadvantages, such as the fact that results are very hard to reproduce by another investigator, because each observational study is usually unique. 
Observational studies (OS) refer to clinical research designs in which the main objective is to observe and report data without any type of intervention whatsoever. They can be conducted over time or, on the contrary, in a unique and specific manner.
In general, they can be classified into two types:
  • Descriptive Study: The objective is to describe and record a disease or attribute in a specific time frame.
  • Analytical Study: It is a comparative analysis of groups of patients in which the investigator merely observes and describes what is happening, deducing possible interventions from routine clinical practice. 

Observational Studies and Clinical Trials

The objectives of observational studies are:
  • To study rare phenomena of a disease 
  • To describe little known diseases
  • To know the clinical course of a clinical entity
  • To obtain frequencies of several variables during the process
  • To show potential risk factors
  • To specify modifications and technological innovations
Whatever the type of observational study to be conducted, at BioClever we comply with all legal regulations because we are aware of clients' needs and offer the most professional results, baed on their specific needs. 
In our company, a CRO that is flexible and has years of experience in the industry, we design and develop EPAs (in all their variants) and Non-EPAs always ensuring professional, high-quality studies that comply with current regulations, since all our studies are based on the quality management system, certified by UNE-EN ISO 9001:2008
For more information about the requirements to develop an observational study for your product, do not hesitate to contact us. 


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Phases of a Clinical Trial

Phases of a Clinical Trial

A clinical trial cannot be started until it has been approved by the competent agencies designated by law. In Spain, approvals are granted by the  Spanish Agency of Medicinal Products and Medical Devices (AEMPS) and an accredited Medical Research and Ethics Committee (MREC).