Data management
A clinical trial management system is a kind of a system or software developed for clinical trial projects management. It enables planning, reporting and tracking all trial aspects. The aim of using an implemented data management system is efficient and proper trial performance at one or several sites.
Using a transparent clinical data management system allows to earn the trust of supervisory institutions and regulatory agencies. We earned trust by ensuring proper consistency in collecting, integrating and verifying clinical trial data. A tried and tested strategy for efficient data management system implementation helps reduce the risk and execution time.
Q&A:
What guarantees trial credibility?
A quality management system guarantees the credibility of the performed trials. A high-quality trial allows drafting correct and consistent documents. ISO 15189 is the standard that governs the quality system and technical competences for medical laboratories. This is a standard specifying the organizational structures of the laboratory, as well as division of responsibilities and determining rules for information transfer. ISO 15189 draws particular attention to the quality of methods and trial equipment.
What guarantees trial credibility?
A quality management system guarantees the credibility of the performed trials. A high-quality trial allows drafting correct and consistent documents. ISO 15189 is the standard that governs the quality system and technical competences for medical laboratories. This is a standard specifying the organizational structures of the laboratory, as well as division of responsibilities and determining rules for information transfer. ISO 15189 draws particular attention to the quality of methods and trial equipment.
What is accreditation?
Accreditation is a formal acknowledgement of the laboratory’s authorization to issue certificates and decisions in accordance with specified standards and to perform duties in accordance with the scope of activity. Accreditations are issued by government entities based on precisely defined procedures. Test results delivered by an accredited laboratory are reliable, resulting in greater social trust, driven by the standards met.
What is ISO 15189?
ISO 15189:2012 specifies the quality and competence requirements for medical laboratories. This standard may be used by medical laboratories to develop quality management systems and estimate their own capacity.
What is ISO 20916?
The ISO 20916 standard defines good trial practice for the planning, performance, recording and reporting of clinical performance trials carried out to evaluate performance of in vitro diagnostic medical devices. The main purpose of ISO 20916 is to ensure that the trials performed lead to reliable and consistent results. This document also specifies the responsibilities of the sponsor and investigator.