Posted on: September 17-2018 | By : Sagar Mahajan | In: Life Sciences,Pharmaceuticals and Biotech | 1 Comment
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
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: January 03-2018 | By : Rahul Ganar | In: Industries,Life Sciences,Pharmaceuticals and Biotech,TMF Management | No Comments

TMF practices have matured considerably, and are now recognized as a critical step in the drug development cycle. However, a number of challenges persist. One key issue facing the entire life sciences industry is the fact that sponsors, CROs and affiliates often maintain multiple TMF instances — which increases the manual work required and creates redundant practices and processes that increase the complexity of TMF management.


Other challenges that the Life Sciences industry faces today include:


  • CRO coordination, to ensure the right documents are available during audits and inspections.In many cases, CROs manage their TMF system and sponsors manage their own. This makes it difficult to ensure the accuracy, completeness and timeliness of documents, as there is no clear ownership or accountability of TMF documents.
  • Governance, for better sponsor oversight and governance of CROs, affiliates and other functional service providers for TMF management. Document submission timeline is also an issue, as documents are often pushed on to the TMF system at the time of inspection, and not on a regular basis
  • Quality by Design, TMF operations for many life sciences organizations are combined with clinical trials and regulatory document management functions. This leads to quality issues, because there is not an exclusive focus on TMF documentation, which needs a more thorough and focused approach.

Is your organization facing any of these challenges? Do you need help providing answers in advance of an audit or inspection? If so, we want to hear from you, learn about your challenges, and explore how we can work together to ensure that your organization is always audit and inspection ready.


To start the conversation, reply or comment below, or reach out to us at LifeSciences@syntelinc.com


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Rahul Ganar

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Rahul Ganar
Rahul Ganar, Senior Business Analyst, Life Sciences, Syntel has more than 10 years of domain and IT...

 
 

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