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T 45: Evolution of e-System to Support Needs of Agile Pharmaceutical Company: A Case Study of Growing Together





Poster Presenter

      Mikhail Samsonov

      • Chief Medical Officer
      • R-Pharm
        Russian Federation

Objectives

Pharmaceutical companies and CROs are facing growing challenges of effective management of Big Data. Integrated approach supported by case studies will be presented in our talk.

Method

A case study based on real system implementation in global pharmaceutical company.

Results

1. Key integration challenges are focused on e-systems for just storing data, investments into the future are usually unclear, the cross-functional nature of big data itself. 2. Pharma – CRO – Site. New Big Data Paradigm, what does it give us? Adopting best industry practices, better data, solving problems quickly. 3. E-System purpose: data integration, optimization of R-Pharm business processes, and as the result - quality and productivity increase. 4. Core of the system, starting with the basics, the critical modules of the system. Then deep dive into system development with systems’ applications and business processes automation. 5. An example of one automation of one business process: goals, timelines, resources. 6. System overall development. 7. Case studies with Investigator & Site Management and PV modules.

Conclusion

Close partnership in e-system development and implementation are for success confirmed by a real life example.