Life sciences document & data management solutions | Modis

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Life Sciences

Content, document and data management solutions

In the clinical and medical affairs areas, a formal approach to the organization and storage of clinical trial data, the disclosure of scientific data and the management of electronic funding requests is key. Optimizing these processes while complying with regulatory requirements takes specialized skillsets and experience. Modis offers content management services ranging from business analysis to system implementation, maintenance and routine support activities. We also provide services in computer system validation and develop user-friendly applications compatible with your current IT landscape – along with training and support on their use. Within the context of the globalization, we support commercial players with data quality initiatives, enabling accurate client market analysis.

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SCOPE OF SERVICES

Comprehensive, flexible, skilled support

  • Our professionals are experts in electronic trial master file (eTMF) systems and their support, through process and organizational design, security and access control, content archiving, change controls, audit trails and system validation.
  • We commit to delivering on time and according to the highest quality standards. We modify our own internal processes to align with yours.
  • Our customer-centric approach enables us to offer a robust and clear quality check of your data. We provide support on scientific results disclosure, coordinate & collect from your different stakeholders the clinical studies, funding, or publications.
  • We always consider the latest GxP regulations and technical backgrounds and limitations of applications, providing suggestions for improvement in the process.
  • Our team works according to best practices such as the PRINCE 2, PMP and V-Cycle project management methodologies. We ensure data integrity by adhering to the ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) principles.

Service overview

  • Business and IT project management
    We can help you define, develop and manage your IT and/or business project, and we also support functional and technical specifications, validation, user support and maintenance.
  • Business analysis services
    We analyze system performance data and manage ticketing services, configuration and end-user communication. Our experts also develop document standards, best practices and system usage procedures linked to applications. We rely on a robust quality check process to reduce the risk of errors.
  • Content & data support management
    Our professionals can take care of data management, DQL reporting activities, operational support, ticket management, user access, data transfer and migration analysis, quality checks, and more.

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Our experts

You can count on professional support from experts in information management and life sciences that share our values of trust, close cooperation and excellence.

  • Business consultants
  • Project managers and coordinators
  • Business and IT analysts
  • Help desk support
  • Back office support

Target markets

From biotech to pharma, Modis offers you the specialisms that your business case requires.

  • Biotechnology
  • Pharma
  • Medical devices

Supporting IT Tools

Every project requires different types of collaboration and knowledge-sharing activities. We’re familiar with all the standard tools available – and many extras.

Modis professionals offer expertise in a wide range of Document Management and CRM systems, such as Veeva Vault, Veeva CRM, Documentum, SharePoint, and publication planning systems such as DataVision® and VisionTracker®.

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BUSINESS CASE

Modis provides pharma leader with an innovative publication platform 

Client core business

This Modis client is among the world’s top three international pharmaceutical companies and a leading provider of vaccines.

How Modis added value

The client was in search of experienced professionals with eTMF and clinical regulation knowledge to implement a new document management system. They also wanted to migrate to this new system from their previous platform and needed maintenance and user support on the new system.

Responding to these needs, we successfully implemented the eTMF system and deployed a team of dedicated application support personnel, project managers and business analysts.

Our professionals supported the customer by:

  • designing relevant business processes;
  • translating business needs into functional and technical specifications;
  • providing support throughout the project lifecycle and after go-live in the areas of content access management, document lifecycle management, user support, reporting and data analysis and more.
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