Friday 09 July 2010

Opening Pandora's box - a discussion on opening your Regulated systems to the outside world?

Friday 09 July 2010

“The challenges of Market Access” Marc Czarka

Friday 09 April 2010

Areas of expertise / Processes

Data Management & Standardisation

With the increase in the number of core activity databases, the need for these databases to be interconnected and the constraints relating to auditability, data must be managed in a way that is detailed, updated and standardised.  Within R&D organisations, meeting these constraints internally is often difficult as resources are mainly focused on development projects as opposed to data maintenance.

Client objectives

• Save time and reduce costs
• Improve efficiencies and quality
• Guarantee the quality of the data managed
• Compliance with ISO standards (Europe) or CMM standards (US)

Product Life's services can cover a number of core R&D activities:

• Regulatory (regulatory tracking of multi-country submissions)
• Clinical fields (clinical trial management)
• Non-clinical fields (toxicology for example)
• CMC/Quality
• Quality assurance (SOP management, corrective actions and preventative actions)

Assignments carried out by the Consulting division of Product Life

The Consulting division of Product Life has worked on the analysis stages of PLM (Product Lifecycle Management) and/or MDM (Master Data Management) projects and has also been involved in the standardisation of data and the definition of system interface guidelines.

Assignments carried out by the Services division of Product Life

The objective of these services is to ensure that core activity data, whether in the form of digital archives, databases or electronic documents, is kept up-to-date, accurate, accessible and available for auditing at any stage. These services relate to the following areas:

• Administration (non-IT) of databases for core activities
• Data capture (input of form data or bulk scanning)
• Data management and data Quality (use of dictionaries, definition of consistency criteria)
• Preparation of data for physical and electronic archiving

• Bibliographic research

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 Whitepaper : DRUG REGULATORY MANAGEMENT SYSTEM  (PDF, 355Ko)