Business Cases

Monday 07 March 2011 Managing the development projects portfolio of an R&D organisation

How an integrated resource management and project management system allows better allocation of resources and activities within the R&D Department.

Monday 07 March 2011 Document management: installation of validated platform

How to define and launch a global EDMS, starting from the R&D’s EDMS.

Friday 04 March 2011 BPO of an administrative process: Contracts management

Complete outsourcing of the overall administrative management and accounting processes for a national coordination service newly created in the perspective to manage multiple contracts and related obligations.

Friday 04 March 2011 EDMS : Optimization and introduction within an eCTD perspective Client

To preserve the eCTD legacy and support evolution of the actual EDMS.

Friday 04 March 2011 Change management: Preparation of documents and dossiers for regulatory submissions

To adapt the business process and tools to comply with Regulatory Submission regulation updates and to increase document preparation and management efficiency.

Friday 04 March 2011 Data management: analysis and extraction of data

Achieving compliance with the European Pediatric Regulation requires the compilation of the pediatric effects described in the marketing authorizations for all the medicines. The highly demanding timetable has forced certain laboratories to create a veritable task force.

Friday 04 March 2011 Clinical Trial Application: preparation, submission and tracking

Support to the preparation, submission and tracking of the Clinical Trial Applications (CTAs) for a multinational company.