In clinical trials, if we analyze, it is the randomization that yields accurate scientific evidence. In other words it means that causal relation between intervention and outcome is result of randomization. Randomization is a method of allocation of treatment in patients in a study at random. What this results in is that every patient/subject gets […]
In any clinical trial, the data generated is the most important thing. In multi centre clinical trials, the data shall be generated in much geography making it challenging to handle the data. Collecting the data from all the sites is a prolonged process in case of clinical trials using paper based CRFs. With the arrival […]
World Health Organization defines a Medical Device as, “any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: Diagnosis, prevention, monitoring, treatment or […]
A CTMS is a customizable software system to manage the clinical trial data generated by pharmaceutical and biotechnological companies. Starting from planning of the research proposal to the preparation, conduct, and report generation, a CTMS maintains and manages the up to date clinical trial data. The early phase clinical trial data is managed and maintained […]
In the research arena, publication of trials or studies conducted is intended towards society for better understanding of the innovative ideas and concepts. But this it is not the sole motive. Other motives are to implement the conclusion in prescribing habits, healthcare resource utilization, make changes in public health policy or regulatory practices. There are […]