Genelife Clinical Research has started its first study for DCGI submission. After playing significant role in conducting pre-clinical studies and global US FDA studies, Genelife Clinical Research has given a progressive start for its first trial for DCGI submission for “Asthma”. As known, Asthma is a common chronic disorder of the airways that involves a complex interaction of airflow obstruction, bronchial hyper responsiveness and an underlying inflammation. This interaction can be highly variable among patients and with patients over time. The study is a prospective “A Multi-Centric, Double Blind, Randomized, Comparative Clinical Trail to Evaluate the Efficacy and Safety of ZU/SER10 in the treatment of Asthma”. In this study the test Drug will evaluated against "Montelukast" one of the best Drug of Asthma. In this study we have to generate data for 200 completed subjects across four sites in two months of recruitment period.
The identification of site was based upon historic performance metrics, type of Institute and its geographic location, paramedical staff, Investigator’s qualifications and their availability for the entire duration of the study, and most importantly their recruitment rate. And to get all the details we performed a feasibility assessment by telephone to determine each PI’s availability, interest, and ability to meet study requirements and procedures.These identified sites comprise of both private institutions as well as government institutions to recruit patients from all economical sets.
Considering the patient recruitment as bottleneck, we at Genelife stressed a lot on selection of right site. Recruitment rate has become more important criterion considering the short recruitment duration. We performed the site selection process with outmost care.
During the site selection processes we have carefully observed the facilities available at site, their patient recruitment rate and their training & amp; knowledge about ICH - GCP guidelines, performance of site in previous trials for a similar indication, audit findings, patient recruitment, lost- to-follow-up rates and finally, results of site selection visits. Site staffing, ability to communicate internally and externally, experience in the area of clinical trials, and logistical handling of case report forms and other data collection instruments. For this particular study we have selected four sites and those are at Mumbai, Lucknow, Hyderabad and Varanasi.
For this Asthma study we have generated additional Logs, to reduce the percentage of errors and discrepancies considering the number of data to be generated at site by the investigator.
Genelife Clinical Research has improved its facilities for conducting this Study in order to provide high Quality Standard.
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GENELIFE CLINICAL RESEARCH
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