DataService - Your Partner in Drug Safety and Clinical Data Management....

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Drug Safety and Clinical Data Management - DataService is Your Partner....

Since 1995 DataService has delivered consultancy services to the pharmaceutical industry in areas such as system

implementations and upgrades; MedDRA implementations and coding migrations; E2B setup, testing and management;

listings for clinical study reports; dictionary upgrade impact analysis; training and lecturing and much, much more.

The overall goal remains adding quality to work and processes at reasonable costs - in a timely manner.

The primary resource is Erik Malte Rasmussen, M.Sc.Dent, DDS, with more than 20 years working experience from

international pharmaceutical companies as specialist and as line manager in drug safety and pharmacovigilance
and in clinical development.

Examples of typical services include: Click for details (opens in a new window)

· MedDRA and WHO Drug Dictionary - Management, Coding, Retrieving, Migration, Upgrades, Training.

· E2B – all aspects of implementing and managing ICH E2B submissions. Sending and receiving.

· Signal Detection programmes. Option to use our cleaned-up FDA AERS data as background/comparison.

· Management and administration of clinical and safety systems.

· Management and assistance in system implementation/upgrade projects. Data migration.

· Design of queries/reports from clinical and safety systems. Compliance tracking applications.

· Pre-scheduled reports with automated email distribution.

· Design of data entry applications with built-in dictionary browsing.

· System vendor selection process and projects. URS, RfP and SOP authoring.

· Contract negotiations with system vendors. Deliverables and financial aspects.

· Audits of IT systems vendors. Get to know your (prospective) vendor quality from ‘behind the scenes’.

· GxP Computerised Systems Validation (CSV). Parts of the process or the complete package as per your needs.