Posted on: September 17-2018 | By : Sagar Mahajan | In: Life Sciences,Pharmaceuticals and Biotech | 1 Comment

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    Traditionally, a trial master file (TMF) has been thought of as a collection of documents to be collated to satisfy the regulatory requirements of a clinical study. While this is still the case, today’s increasing use of electronic TMFs and integrated clinical systems is giving the industry a more holistic and real-time view of clinical trial activities.

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    Sagar Mahajan

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    Sagar Mahajan
    Sagar is having 10+ years of rich experience in delivering projects pertaining to Clinical...

     
    Posted on: August 23-2018 | By : Gauri Deshmukh | In: Clinical data management,Industries,Life Sciences,Pharmaceuticals and Biotech,SEND Services | 1 Comment

    The pharmaceutical industry is undergoing a huge transformation. The traditional ways of clinical research will soon be a thing of the past, with disruptive technologies like machine learning (ML), artificial intelligence (AI), natural language processing (NLP) and robotic process automation (RPA) moving from niche positions to sweep across the pre-clinical and clinical research value chains

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    Gauri Deshmukh
    Gauri Deshmukh is a Senior Consultant – Life Sciences at Syntel, providing Domain Solutions to...

     
    Posted on: August 16-2018 | By : Shailesh Gadhave | In: Digital Age,Digital Solutions,Life Sciences,Pharmaceuticals and Biotech | No Comments

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      The life sciences industry today is undergoing a wave of disruption, with biopharmaceutical companies embracing potential new ways to deliver a value-based model over volume by developing specialty products in target segments.

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      Shailesh Gadhave
      Shailesh is a post-graduate candidate in Marketing-Life Sciences with passion for developing novel...

       
      Posted on: March 26-2018 | By : Sourav Gupta | In: Industries,Life Sciences | No Comments

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        The journey so far

         

        Year 2017 was a learning phase for the Medical Device industry. With the official launch of the European Medical Device Regulations (EU MDR 2017/745) and European In-Vitro Diagnostic Regulations (EU IVDR 2017/746), many medical device and in-vitro diagnostic companies faced uncertainty and confusion over the new requirements, as well as risks and challenges to their business.

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        Sourav Gupta

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        Sourav Gupta
        Sourav Gupta has 14+ years of experience supporting the Life Sciences industry in the clinical,...

         
        Posted on: March 12-2018 | By : Imran Sheikh | In: Life Sciences | 1 Comment

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          Although high-profile data breaches grab the headlines, behind the scenes, life sciences is just as information sensitive as any industry. Any pharma company faces a major challenge when it comes to complying with the myriad regulatory requirements about how they create, handle and submit documentation about the products they manufacture.

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          Imran Sheikh

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          Imran Sheikh
          Imran Sheikh is Sr. Consultant, Regulatory Affairs at Syntel. He has over 10 years of rich...

           
           

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