Vendor selection (EDC / ePRO)
Cross-functional stakeholder interviews; business case writing; RFI and RFP process, vendor evaluation and selection; management presentation; budgeting and contracting.
EDC and ePRO implementation
Interface between sponsor and vendor, analysis and adjustment of business processes and application features, feasibility and formal testing, creation of trial specific SOPs for pilot studies.
Business support unit (“EDC office”)
Mentoring of study teams during set-up, conduct and close-out phase, “translator” between study team and vendor staff, creation of trial specific SOPs, UAT support.
Training (EDC, ePRO, CTMS)
General and study-specific trainings for internal and external users of eClinical applications. Determination of training scope, preparation of training material, global training rollout.
Business Process Re-engineering
Analysis of EDC related processes within a global data management department and interfaces to external resources from EDC vendor and CROs. Project lead to establish and implement new processes. Communication to internal stakeholders and external partners.
Implementation of CTMS middleware
Development of a CTMS middleware connected to Impact and other data sources. Definition of user requirement specification, vendor briefing, project management, UAT and approval. Report specifications, development management, UAT and approval. Supervision of global rollout, user training and support.
Development and maintenance of a study management tool for monitoring of patient compliance. Creation of data analysis and management reports.
Evaluation of coding tools for EDC integration
CDISC introduction / evaluation on management level
SOP writing / maintenance related to use of eClinical applications