Analysis, Design & Implementation

Enterprise content management issues in a pharmaceutical or biotech environment typically spans across business areas from molecular modelling or compound discovery through post-marketing and vigilance for various countries and regions. Providing analysis in this space involves a number of issues. These include requirement of in-depth knowledge of impacted regions, markets, business and technical issues spanning the drug development life cycle to post-marketing and pharmacovigilance. Due consideration also needs to be given to impacted systems, business units and procedures that deal with phases I to IV clinical trials, data management and biostatistics. We provide analysis and solutions in this space.

The nature of the pharmaceutical industry requires adherence to established industry best practices specified by organizations such as the FDA, CDISC, HL7, etc. We work closely with business and technology areas to blend industry best practices with business processes using our validated systems approach complimented by our robust enterprise framework, configurable tools and methodologies.

Some of the pharmaceutical industry’s best practices such as organization of content in ICH-9’s eCTD format (Electronic Common Technical Document) are required to be incorporated in a regulatory submission management or publishing system for NDA delivery. Others such as CDISC’s SDTM standards are fast catching up with compliance groups overseeing these moves.

Yet others such as XM Labeling standards are fast catching up with regular updates suggested by industry partners. Our tools and technologies work in an integrated manner with specified or upcoming industry best practices. For a list of pharmaceutical industry best practices and standards, please visit our site www.pharmware.com