Regulatory compliance and optimized business processes around clinical
and non-clinical documents

CHALLENGES AND BUSINESS IMPLICATIONS

Challenges:

  • Managing clinical trials and submissions documentation across different sites and countries and better managing the higher expectations of health authorities
  • Getting primary regulatory approval as quickly as possible and extend to “Secondary” regulatory approval
  • Mergers and acquisitions – manage huge volumes of product information
  • Enforce the right level of security to protect intellectual property

Business Implications:

  • Extreme cost for time to market complex interactions with partners and authorities throughout the drug development lifecycle
  • Lost in revenue potential for the product
  • Difficult to capitalize on U.S. and European approved drugs in global markets
  • Time to value extended significantly
  • High cost and missed opportunities to effectively manage the acquired firm’s business records
  • Increased company exposure to competitors

SOLUTION OVERVIEW

SEAL for Life Sciences harness an information architecture based on the Drug Information Association (DIA) Electronic Document Management (EDM) and Trial Master File (TMF) Reference Models. If you are looking for a next generation low-code content and process services platform for Life Sciences to meet regulatory compliance requirements, increase efficiency and productivity, as well as securely collaborate across the enterprise and outside with the trusted 3rd parties, SEAL is the proper choice for your company.

  • Electronic Trial Master File: Effectively plan, collect, track and maintain essential GCP-compliant clinical trial
  • Research and Development: Manage the creation, review and approval of regulatory submission
  • eSubmission: Simplify the search and retrieval of archived submissions and associated correspondence, while improving security and
  • Integration: connection with CTMS (Clinical Trial Management System).
  • Monitoring: follow performance indicators like completeness (trial completeness, document progress, release status), quality and timeliness (average days from creation to approval, average days in QC, approval time per CRO ).

VALUE PROPOSITION

Supporting the drug development lifecycle:
  • Preclinical phase – supporting drug discovery and submitting for clinical phase;
  • Clinical trials- Electronic Trial Master File to effectively plan, collect, track and maintain essential GCP-compliant clinical trial documentation;
  • Development and submission for regulatory approval – creation, review and approval of regulatory submission documentation while improving security and compliance;
  • Manufacturing and QA – Control quality and manufacturing documents, automate workflows and ensure GMP compliance.
Supporting FDA 21 CFR Part 11 requirements:
  • Ensure the authenticity, integrity, and confidentiality of electronic records;
  • Generate accurate and complete copies of records for the FDA to inspect and review;
  • Ensure the security and easy retrieval of electronic records;
  • Maintain a log of all changes made to electronic records throughout their lifecycle;
  • Record and store electronic signatures with the originating electronic records.
Supporting EMA requirements:
    • Trial master file (TMF) structure and content governance for sponsors and investigators, contract research organizations (CRO) and 3rd parties;
    • Security and control of TMF;
    • Scanning or transfers to other media;
    • Archiving and retention of TMF leveraging advanced records management capabilities.
 

HOW IT LOOKS

SOLUTION BENEFITS

  • A next generation, compliant and scalable Content and Processes Services platform;
  • Best TCO (total cost of ownership) – competitive pricing (capacity based) especially for large number of users, fast implementation, rapid user adoption, low maintenance costs;
  • Best user experience – designed for business / non-IT users, easy to configure, easy to adopt and use, delivering improved business productivity and efficiency;
  • Metadata driven platform – expanded metadata management and metadata-based automation capabilities to automate ingesting, classifying and managing content metadata;
  • All-in-One – designed as an end-to
    -end content services solution to address full content management needs, including document capture, OCR, workflow, records management, life cycle and archiving;
  • Easy to implement integration and connectivity capabilities with both on-premises and cloud applications through extensive APIs and interfaces and standard connectors/migrators (SAP, SharePoint, Documentum, etc.);
  • Strong mobile and cloud capabilities – native mobile clients for iOS and Android, CMIS for simple integration, designed for Cloud and SaaS providers with multi-tenancy capabilities.

SMART SOLUTIONS BUILT ON TOP OF ADVANCED PRODUCTS

A next generation software solution for AI and metadata-driven content efficiency, compliance and process automation platform.

Connect, capture, index, share and securely manage your entire electronic archive while maintaining compliance.

At a fraction of the cost usually paid for classical ECM systems, SEAL is an enterprise information archiving system that enables you to capture, transform, index and securely manage your entire electronic archive, while still maintaining the necessary compliance and governance toolsets.

NOT CONVINCED? SEEING IS BELIEVING

*By filling in this form you agree that your contact details are to be used by Star Storage in other communication campaigns. For more information, please see our Terms and Conditions.

Stop COVID-19! Work DIGITAL with ZERO risks

Stop COVID-19! Work DIGITAL with ZERO risks

ZERO-DISTANCE Business with
StarCapture Anywhere!

ZERO-DISTANCE Business with
StarCapture Anywhere

Star Storage partners with Hewlett Packard Enterprise

StarVault Dedicated Infrastructure