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Observational Studies

Observational Studies
The medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization

A Non-Interventional Study or Trial is a study where the medicinal product is prescribed in the usual manner, in accordance with the terms of the marketing authorization.

Non-interventional studies (NIS) are an essential part of clinical development activities. Non-interventional trials include post-marketing surveillance studies (PMS), post-authorization safety studies (PASS), cohort studies, case-control studies, and register studies. The data obtained are derived from the routine treatment of patients, not from additional diagnostics, and collected as well as analyzed with the help of our digital systems.

Whereas in phase I-IV clinical trials the efficacy of an investigational product is explored in a patient population which has been selected according to strong inclusion and exclusion criteria, in non-interventional trials, patients are treated under real life conditions to investigate the efficacy of a drug.

Services we provide regarding Non-interventional studies:

Study Design and Start-Up

BioClever is experienced in a wide range of non-interventional studies:

  • Non interventional studies: Case controlled studies, Cross-sectional studies, Cohort studies.
  • Post-marketing surveillance studies
  • Drug utilization studies
  • Registry

Project Management

At BioClever, all our staff come from the clinical research sector. They have wide experience in management and consultancy methodologies and offer our clients quality service that will deliver projects on time and on budget. Projects are thoroughly followed up throughout, and any potentials risks are minimized as far as possible.

Clinical Monitoring

Our CRAs are experienced in working effectively with sites to ensure that patient recruitment and study milestones are met.

Our annual staff turnover is low (less than 5%) and our employee satisfaction is high (90% of our people are happy and feel valued in their job*), so we can assure our clients that the same CRAs who start up a trial be there at close-out.

Data Management and EDC

Our team of professionals is equipped to perform all the activities required to conduct a top quality clinical trial. They will design the CRF or eCRF, create and validate the database, manage and code all AEs and SAEs, and process and enter fuly coded data according to international dictionaries.

Statistics

All our studies are conducted according to standard operating procedures that comply with the ICH guidelines E9 (Statistical Principles for Clinical Trials) and E3 (Structure and Content of Clinical Study Reports). These procedures are implemented at all stages of the process, including protocol writing, statistical analytical planning (randomization, sample size calculation, etc.), statistical programming (reports and statistical analyses), and providing statistical consultancy to the medical community.

Medical and Scientific Writing

Our medical writing team is fully involved in R&D design, clinical writing, medical monitoring and biostatistics.

All processes involving clinical trial reporting are conducted according to the ICH:E3 guideline (Structure and Content of Clinical Study Reports), generating trustworthy and quality results for our clients.

  • BioClever Barcelona
  • Rambla Catalunya, 135, 3º 1ª, 08008 Barcelona
  • 934086388
  • info@bioclever.com
  • BioClever Madrid
  • Ronda de Poniente, 10 28760 Tres Cantos - Madrid
  • 910888877
  • info@bioclever.com