Areas of service:
  • Expert solutions for pharma companies
  • Data management
Client’s Context

XPE Pharma & Science is one of the leading Belgian companies for the contracting of highly qualified scientific, and a top player in providing scientific outsource services to pharma and food industry.

Business Challenge

Strict control of clinical trial timelines are crucial for the development of new drug; real-time clinical trial data collection and reporting of results bear significant advantages to Pharma Company. New data standards such as CDISC are changing the way in which data are collected, stored and analysed, Clinical trials require that accurate, consistent and secured records should be kept. In addition, it is not only about hardware and software. The shift from paper to web and cloud data comes with training requirements for all users and with a stronger focus on privacy and data protection. Therefore, any digital solution for sensitive clinical patient data management has to be also userfriendly, so that the non-technical users can easily access, collect, enter, analyse, check and report on that data. There is also the need to improve the quality, reduce time and cost, automate and facilitate validation actions, then integrate data sources and transform data into real, useful and actionable information.

Our solutions

Based on the expertise available in Atracore, a dedicated data management team has been setup to manage surveys, market research, reimbursement programmes and observational study. Having on board scientific experts involved in development for many years, computer engineer exposed to the pharma sector, expert in software validation for the pharma industry, Atracore proposed a scalable technical solution, cost-efficient without jeopardizing the quality. A Data Management Expert works in the client’s data management area, covering an entire array of activities and responsibilities:

  • Preparing the process for collecting, management, review and report data from clinical trial/registry
  • Preparing the validation strategy and tools and references responsibilities for different tasks
  • Defining the systems used, establishing the projects’ timing, risk situation and data flow
  • Creating and configuring data entry application and the database
  • Assuring audit trail, data validation, quality control
  • Covering the query process and data correction
  • Implementing functionalities for secured access, data lock/ unlock, track changes
  • Offering hosting and support for data entry
  • Developing trainings/ eLearning for other users
XPE Pharma & Science benefits in working with Atracore

Besides a secured and strong partnership that is at the basis of our collaboration with the client, XPE Pharma & Science benefited from the following:

  • near-shoring, which combines the operational efficiency of outsourced staff with the costsavings of off-shoring;
  • Scientific/ technical background of the team, making the new staff part of a culture of technology understanding and innovation