The client wanted to move from 100% paper CRFs to 100% EDC for new trials, with the data integrated into their Clinical Data Management System for creation on raw SDTM analysis files. The goal was achieved in 10 months, from initial idea to go-live, and reduced the time from LPLV to database lock to 2 weeks.

The client’s business had rapidly expanded over the last ten years and was now facing the challenge of a fragmented and cumbersome SOP landscape with no overall structure. They needed to develop a new optimized and aligned framework that was scaled to match the pharmaceutical company they…

The company needed to align the processes in all 4 divisions, and create a consolidated view of all trial planning and execution activities. Implementing best practice for RBM in order to save time for monitoring, giving the capability to run more trials with the same staff. Migration of old legacy systems, new processes and training…

The client needed one place for all study teams to work and share files and operational information for studies being run internally and outsourced to CROs. In order to support all study scenarios, a flexible portal with modules was needed. Analysis and strategy were done in 3 months, and the first trial…

Client wanted to spin out it’s drug discovery operations into a new company within a strict timeline. This included transition of a number of studies and associated documents to a new integrated eTMF solution fully applying to DIA reference model 3.0, with no or limited time to fail

The client was struggling with
local installations of statistical programming tools making it difficult for the IT department to manage and support. The statistical programmers experienced slow connectivity to data which resulted in local copies of programs and datasets. Cumbersome manual processes for data access