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Last Updated on Wednesday, 25 November 2009 16:37

Close to Customers & Technology Providers (at the intersection) …

Offering Vision & Strategy covering the following (but not limited to) areas:
  • Electronic document and content management in the Global Life Sciences industry
  • Submission type and content preparation, management and registration tracking as they integrate with EDM reference model
  • Harmonization of metadata and standards (e.g. International Conference on Harmonization [ICH])
  • eDiscovery, leading to an Enterprise Information Governance, Strategy and Architecture
  • Consistent content from R&D to Patient/Providers and back to Drug Development
  • Structured Content Authoring (SCA, XML base) strategies, to include Intelligent Content Design (ICD)
  • Product Information Repository for regulated content
  • Regional regulations, including the Food and Drug Administration (FDA), European Medicinal Evaluation Agency (EMEA) etc., including submission types like IND/IMPD, CTA, Labeling (PIM, SPL, others) to complete full Dossier and beyond;
  • Pharmacovigilance (PV); Drug Safety Reporting (ADR, ICSR etc.)
  • Risk Management (RM) of non-compliance

… our Services include such as:

Vision & Strategy for optimal use of Corporate Information assets, or fractions thereof may likely include (within proven methodologies): While considering the fact that global information exchange standard continue to be implemented and to further emerge, a top down approach is highly recommended.

However, LSCP has also developed a methodology that has already been proven, for a pragmatic approach by still respecting and building an enterprise frame:
  • Current status assessment (can be domain specific for the pragmatic approach)
  • Option space for a new business and technology platform
  • Designing the framework for a Proof-of-Concept to Pilot, learning
  • Corporate Information Governance (CIG)
  • Business Architecture (BA) to enable your business model(s)
  • Enterprise or departmental level:
  • Information Architecture (EIA),
  • Content Modeling (ECMo),
  • Process Modeling (EPM),
  • Intelligent Content Design (ICD),
  • Structured Content Authoring (SCA),
  • Change Management (CM),
  • Risk and Mitigation Management (RMM)
  • Information & Communication Technology (ICT)
  • Economic Modeling (EM)
  • Total Cost of Ownership (TCO)
  • Knowledge Management (KM)
  • Business Requirements for Vendor Evaluation (RVE)
Business engagements are coordinated by a selected LSCP Management Team Member, or an Associate Partner, to face customer needs. The teams may be multi-functional and multi-geographic.

How to optimize content re-use?

Based on eCTD and related standards, our activities are grouped within programs with which we can globally assist customers who desire achieving consistency, transparency, effectiveness and interoperability.
These programs include:
  • eCTDMOVE
  • eCTDPLUS
  • SCA as the starting point
  • extended Intelligent Content Framework (ICF)
  • eHealth holistic approach