Series Four, LLC is an IT consultancy focused on providing Information Management services and solutions for the Life Sciences industry. Series Four brings years of knowledge and experience to support our clients’ IM initiatives in both Research & Development as well as a wide range of business areas within Commercial Operations.

Our experiences span mission critical processes across the Life Science value chain.

      We understand the challenges with launching and expanding therapies and recognize that even though companies may compete and operate in the same market, each company has different needs based on their business strategies and operating models. That’s why our strategy and planning methods are tailored to the specific nuances of a company’s therapies, markets, and business drivers.
      Our team brings knowledge and expertise based in multiple projects and initiatives with established large and mid-market pharmaceutical companies as well as the fast-paced setting of small and emerging biotechnology companies in the process of commercializing and launching new cutting-edge therapies.
      The Series Four team is well-versed in the Life Sciences industry with a deep understanding of critical business processes, data and information exchange, KPI’s and analytics, underlying systems architecture, and regulatory compliance requirements.
    

Series Four’s eimDB application is based in years of experience and designed specifically for emerging biotechnology and pharmaceutical organizations. eimDB provides a flexible, configurable, and comprehensive repository to track and manage critical governance information.

Critical information and content assets.
Asset types and storage locations.
User ownership and access rights.
Technology platforms and application.
Tracks records retention and disposition schedule.
Policies, standards and regulations such as 21 CFR Part 11, HIPAA, GDPR, & SOX.
Evidence to support Computer Systems Validation.

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eimDB enables Regulatory Compliance across the enterprise:

Reduces risk of non-compliance with FDA, HHS, OPDP and global agencies
Enables identification, protection, and control of PII, GDPR and PHI/HIPAA-applicable assets
Expedites regulatory agency query, reviews, and inspections
Provides readily available lineage for certified assets
Enables auditable, consistent processes for record keeping and CSV