IT Applications

Specializing within Pharma, Biotech and Medical Device Industry Pharma IT possess deep insight into the sector specific IT applications used. Below an indication of the applications we are working with, but the list is by no means exhaustive so don’t hesitate to contacts us to discuss you needs:

  • Electronic Document Management Systems (EMDS)
  • Training Management Systems
  • Records Management Systems
  • Change Management Systems
  • Test Management Systems
  • Security Management Systems
  • Master Data Management Systems
  • Laboratory Information Management Systems
  • Clinical Trial Management Systems (CTMS)
  • eCRF Systems
  • eTMF Systems
  • SEND/CDICS Systems
  • Submission Systems
  • Regulatory Information Management Systems (RIMS)
  • ERP Systems
  • Product Life Management Systems
  • Serialisation
  • Safety and Pharmacovigilance Systems
  • Signal Detection Systems
  • Pharmacovigilance System Master File Systems (PSMF)
  • Healthcare Professional Management Systems (HCP/HCO/PO)
  • Interlectual Property Management Systems
  • Service Management Systems

If you need support don’t hesitate to contact us.

Meet the IT Applications team:

Senior Consultant, Architect
Nikolaj Brasen

IT Architect with vast experience within systems design, as technical lead, requirement analysis, system management, ensuring GxP-compliant documentation and planning with stakeholders to obatin the best possible solutions within the budget and timeline. Nikolaj Brasen has an eye for details, an ability to maintain overview and long-term perspectives, a firm understanding of risk, and is familiar with the latest project management tools and practices (DevOps, Agile, Scrum, and more)

Veeva Vault Platform, PRINCE2, TOGAF 9 Certified
Junior consultant
Elvin Iruthayam

Elvin Iruthayam is a junior compliance/student consultant currently studying a M.Sc. in Biomedical Engineering.

Pharmacovigilance Consultant, Quality & Compliance Consultant
Maria Skou Andersen

Cand.pharm with five years of pharmacovigilance experience including strong knowledge of MedDRA coding. Successful completion of EMA’s XEVMPD knowledge evaluation. Capable of providing guidance and training to new EVWEB users for them to comply with the reporting guidelines. Capable of creating and updating XEVMPD records. Experienced with databases such as Argus, Empirica and QlikView. Currently studying Master of Pharmacovigilance at the University of Hertfordshire, UK. EDMS system expert with advanced Veeva system administrator certification and experience with Veeva implementation. Experienced with compliance tasks such as system validation within the drug safety area.

Certified Veeva Vault Administrator, Veeva
Business Consultant
Sara Halsskov

Holds more than 15 years of experience working in the pharmaceutical industry, working with IT systems and processes, primarily within Regulatory Affairs.  Sara has performed the role as Clinical Publisher, Regulatory Application Professional, eSubmission Manager, Senior QMS Professional/Project manager within Regulatory Affairs and Release Manager as part of System Management.

ITIL Foundation Certification, SOP Expert training, Writing effective standard operating procedures and other process documents (CfPIE), Computer Validation, Veeva
Senior Pharma Consultant
Peter Noes

Information technology professional with more than 15 years of experience from the pharmaceutical industry. Extensive business understanding and experience from IT projects mainly within the areas of Regulatory Operations – eSubmission/eCTD, Regulatory Information Management Systems (RIMS), Electronic Documents Management Systems (EDMS), XEVMPD and IDMP. Broad experience with project management, system administration and system implementation and with establishing and optimizing business processes within GxP areas.

Veeva White Belt Certification, Computerized System Validation/GAMP5 and GDPR Foundation
Quality & Compliance Consultant
Benedikte Marie Due

More than 10 years of experience with IT compliance. Working as Validation Track Lead in IT implementation projects and as Business Consultant in system operation and maintenance.

Experience primarily with corporate GxP systems within the Regulatory, Quality and R&D area. Also experience with international projects, external vendors and offshore personnel.

Certified in Computerized System Validation/GAMP5, Certified Veeva Vault Administrator, Veeva
Business Consultant
Luise Søgaard Rosendahl

Holds extensive experience in the pharmaceutical industry working with IT Service Management, IT implementation projects, and IT Transition and Transformation programmes. Has played pivotal roles in IT system management organisations responsible for applications supporting Product Supply. Furthermore hands on experience as Business Consultant, IT Management SME, and Track Lead as part of a Management Consultancy organization.

ITIL®V3 Foundation, ITIL®V3 Intermediate RCV, NLP Business Practitioner, SAFe Agilist
Business Consultant, Quality & Compliance Consultant
Lene Hyldgaard Jensen

Experienced Business Consultant with more than  10 years’ experience in the pharmaceutical industry working in various business partnering roles, preparing business analysis, facilitating workshops, transforming business requirements into IT development and implementation projects and delivering subject matter expert assignments, especially in the Regulatory area. Hands on Quality and Compliance experience with GxP IT systems and writing of Standard Operating Procedures.

ISPE GAMP 5, ITIL, Project Management, GLP, GCP, Veeva
JRK 2017 BW
Business Consultant
Jannie Rosenkjær Melbye

Senior Pharma Consultant with 11 years’ experience within document/information and application management. 17 years’ of experience in the field between IT and business. Experience with GxP, application management – especially document management, functional and technical support, test and validation. Furthermore, experience within ITIL, vendor management, communication with end users, transition and application management.

Certified in ITIL, Computerized System Validation, SAFe Agilist