eClinical Processes & Systems

We will support you through all aspects of an implementation or change of processes and systems. From requirements collection, vendor selections and system validation to process definitions, SOPs and training. We will also provide help establish governance processes such as Data Quality Management, Standards Management and Risk Management

Systems

EDC/eCRF
ePRO/eCOA
Data Repository and SCEs
Data Review Tools / Data Browsers
Data Analytics, Visualizations and Interactive Browsing for all types of Data
RBM Tools
System Integrations (ePRO-EDC, EDC-Safety system, IRT-EDC)

Processes

Data Collection
Data Cleaning, Data review and Coding
Data Handling and Data Quality Management
Standards Strategy/Management/Governance
System/Vendor selection, Implementation, Validation
Legacy Data and Systems Handling, Decommissioning
Sponsor Oversight
Risk Management

Experience catalogue »

Strategy & Business Plans

Defining your sourcing strategy, designing core processes and establishing systems, data and activity architecture – what goes on where and by whom. TriTiCon has the experience to help define the strategy that is right for you. We will support you in defining your organizational model, the roles and types of systems you need (and do not need) and in finding the right type of vendors.

System Architecture and Strategy (systems landscape, owned system or buy as per-trail service, hosted or in-house)
Standards Strategy
Sourcing Models (in-house/vendor splits, insource, outsource, offshore)
Organizational Set-up, Role Descriptions, Recruitment

Experience catalogue »

Trial set-up & Execution

We are not a CRO but can help you manage your clinical trial set-up and execution. TriTiCon can support you from vendor selection and contracting, through set-up, operations and oversight. We can author or review specifications, oversee set-up and perform UAT of clinical systems.

End-to-end management of ePRO/eCOA in trials (Vendor selection, set-up specifications (URS), test (UAT) , documentation, monitoring)
Outsourcing of EDC/eCRF, Data Management, Programming and/or Statistical Services (RFI/RFP, Selection, Contracting, Oversight)
Lead and manage set-up of interfaces

Experience catalogue »

See our Experience Catalogue on the Resources Page