Sunday, January 13, 2013

Genelife Clinical Research- Ongoing Medical Device Clinical Trials

Genelife Clinical Research has started its first Medical Device Pilot Clinical Study for US FDA submission. Although we have participated in couple of US FDA studies in past but both were Pharmaceutical Clinical Trials. This is first time we are going to start a Medical Device Clinical Trials for Medical Device, within ENT therapeutic area. 

The study will be performed in a single site in India and we are hoping to recruit all patient volunteers in one month. The site selection procedure was dependent on not only the historic performance, type of Institute and its geographic location, paramedical staff, Investigator’s qualifications but we also considered the importance of patient referral. This we did considering the importance of project as well as the dependence of season on recruitment. 

Like our past studies we are hoping to complete this study before the time we proposed to our Sponsor. Hope we will achieve our target.

Kind Regards,


  1. Congratulations Dhiren..!!! All the best for your current and upcoming future projects.

    Ashish Aggarwal

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  3. Congratulations Dhirendra, Hope this leads to good capability building for Medical Device studies.

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  6. A big congratulations to you Dhirendra! Surely you will come up with more beneficial clinical research in the future. I'm looking forward and excited for your future projects.

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