Government issues new rules for Drugs and Clinical Trials
2019 to reduce approval time for applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
Staff at clinical trial
sites and pharmaceutical companies conducting clinical trials
will use a specialized website to access data stored in a cloud environment, so operations previously handled manually at clinical trial
sites by Clinical Research Coordinators (CRCs), such as printing and mailing paper documents, will be streamlined.
Throughout her career she has worked across a variety of categories to manage teams within the clinical trial
space, conceptualising and implementing the most cost-effective strategies to accelerate clinical trial
patient recruitment and retention.
Brazilian Clinical Trials
The number of clinical trials
in the world last year was 16.3 percent less compared to the previous year, but the number of trials in Korea remained at the level despite the global trend.
information being made available for scientific research will include protocols, full clinical study reports (CSR) and de-identified patient-level data and study-level data for medicines and indications approved in the US and/or Europe for trials completed after January 2008, added the company.
Registry (CTR) provides an internationally-concurred set of details about the design, conduct and implementation of the clinical trials
* Reconsenting of subjects based solely on the new requirement is not required for clinical trials
initiated before 7 March 2012.
Written by authors with considerable experience in this field, the book is an authoritative guide for clinicians, data managers and medical statisticians involved in clinical trials
Corengi is dedicated to helping individuals discover more about clinical trials
that may be appropriate for them, and committed to building a free, comprehensive, and interactive platform for a variety of diseases.