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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.


As such, regulatory bodies now expect a TMF to be the story of “how the trial was conducted and managed.”


Migrating eTMF documents within systems is not an easy task. Migration is much more than mapping document types and artifacts, and harmonizing the metadata.


DIA is proposing a universal mechanism for document transfer, which is referred to as eTMF Exchange Mechanism Standard (EMS). The preliminary version was released by DIA at its global meeting in Boston in June 2018, so let’s take a look at the background and specifications of this important development.


The new EMS standard will become a major milestone, helping resolve major issues the industry faces when trying to migrate from one platform to another. It will also facilitate the exchange of eTMF content between CRO organizations and from one system to another. The standard includes a specification document, Exchange.xml and Exchange.xsd. (schema for validation of XML format). The schema for exchange is currently in the development phase.


The model specifies different tags required to encapsulate files and metadata values, individual objects, artifact files, electronic signature displays on artifact files, and audit trail entries for artifacts being exchanged.


The eTMF-EMS process operates between two different systems. The originating system produces the output of artifacts within a predefined folder structure with an Exchange.xml file, which further undergoes validation with the help of the Exchange.xsd schema. When the target system imports the Exchange.xml file, it performs the same validation checks, imports all artifacts, and files them under relevant TMF artifact number within the system.


When it comes to implementing EMS, there are a few potential scenarios:


  • Study or Contract Closure: Final eTMF transfer to sponsor from CRO for archiving
  • Merger and Acquisition: Migration of eTMF content
  • Platform Change or System Upgrade: Migration eTMF documents

Today, companies understand the value of compliant and inspection-ready TMF documentation throughout the clinical development lifecycle — and it has become critical to keep these documents ready as and when required for smoother market access.


In the next installment, we will shed a little more light on EMS and discuss a few interesting use cases and best practices for implementing EMS within your organization. Stay tuned.


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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


With new FDA requirements that took effect in December, 2016, you must be able to receive and submit non-clinical toxicology study data in the SEND format. The new SEND standards have a major impact on the industry, as they are now binding for all sponsors submitting non-clinical data to the FDA — re-structuring the way non-clinical data is collected and submitted.


Long-running legacy processes and a lack of standards have led to inconsistent data standards that differ from company to company. Moreover, there may be inconsistency at many levels within a single organization, depending on the enforcement of these standards.


Deadlines


The major challenges that the industry is facing with SEND implementation are:

Lack of resources with deep SEND and study-specific expertise

  • Deep standards knowledge is required for trial design creation and Study Data Reviewer's Guide (SDRG) content analysis and authoring

Tools for viewing study data and cross-study analytics

  • Increasing need for data exploration
  • Deployment, integration, advanced visualization and support for the selected system(s)

Global harmonization of SEND processes after mergers & acquisitions

Time-consuming and costly manual data QA checks

  • Existing products do not provide certain automated data checks
  • Many companies are using older Laboratory Information Management Systems (LIMS), which do not support SEND-compliant data collection

Data merging issues

  • Use of multiple LIMS systems
  • Multiple source files from CROs, in-house labs, etc.

Implementing SEND standards requires deep knowledge and expertise in understanding, planning, implementing and submitting non-clinical data to regulatory bodies. Small errors complying with SEND standards may result in a rejection, making it imperative that your submissions are prepared by experienced and knowledgeable subject matter experts.

We are here to listen. At Syntel, we understand the core problem, and put our experience to work addressing this challenge with a two pronged approach.

  • Ready pool of SEND SMEs. Implementing SEND standards is a niche skill, and it can be difficult to identify and hire the right team members. Syntel has a comprehensive process to find the right talent for your organization, including a n extensive screening process, SEND-specific training, an ongoing competency building approach, and a robust knowledge management framework.
  • Quality assurance (QA): QA demands 100% adherence to SEND standards and processes, along with data consistency. We ensure that your SEND data is consistent with the original LIMS data resource, and conforms to the FDA’s implementation of the CDISC standard.

Syntel offers a full range of SEND operational and data management services, with a pool of trained, talented team members ready to deliver high-quality service based on SEND and QA processes, established information security controls, and a scalable model ready to help you build a world-class SEND organization.


If you are ready to put your SEND compliance initiatives on the right track, you need to talk to one of our experts today and learn how Syntel can deliver the mix of skills and quality that you’ve been looking for.


Contact us at Syntel_lifesciences@syntelinc.com today.

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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.


This wave of change is due to the fact that science and business operations are becoming increasingly complex, competitive and global — with companies attempting to make a comprehensive impact in this highly competitive marketplace. With increasingly complex development processes and soaring research and development (R&D) investments, stakeholders (business, end users, investigators, etc.) are looking for a more robust, reliable and reproducible approach to bringing personalized products to the market.


Even though the digital technology exists today to optimize the entire R&D value chain, adoption is low — especially in clinical trials segment — because of factors like complexity, resource-intensiveness, changing regulatory dynamics and lengthy implementations. However, while these factors may seem like an argument against implementation, the rewards are worth the effort.


As industry leaders move towards adopting personalized medicine and a patient-centric approach, it is increasingly important for clinical development enterprises to gain access to the growing volumes of patient historical data, real-world evidence, genomic profiles and emerging research to meet sponsor expectations. Harnessing this data can help investigators get a 360º view of patient performance and demonstrate the true value of new treatments to key stakeholders for effective market access.


Digital technologies can transform how companies approach clinical trial management, by enabling them to access a wealth of information from different data sources, improve patient enrollment and trial experience, capture real-time data insights and improve the quality of data collected during trials. Collectively, this can help achieve the following clinical objectives:


  • Expedite patient enrollment and retention by mining unstructured patient health data and identifying the right patient-trial match

  • Enhance patient trial experience to transform subject onboarding, trial understanding and helping set realistic expectations

  • Build an integrated trial management platform that can capture, integrate and analyze complex data during trials

  • Manage / regulate multiple sites and trace performance using advanced analytics and visualizations, enabling early intervention or shutdown of non-performing sites

  • Effectively manage stakeholder expectations and performance delivery


In our opinion, adopting digital technologies is an imperative strategy for clinical development enterprises. Emerging technologies like artificial intelligence, machine learning and advanced analytics are empowering CROs to reduce cost, integrate trial management, establish a tighter control, enable smart manual intervention, deliver quality outcomes and reproduce results in multiple scenarios.


In upcoming posts, we will further explore this promising synergy between technology and science to advance innovation in medicine. Stay tuned!



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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


Author
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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