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Press Release: Achieving eTMF Success and Inspection Readiness” Matthias Poensgen, Clinical Expert at ArisGlobal Speaks at Trial Master File Summit

MIAMI, FLORIDA.  January 11, 2018, 2017 — ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, announced that Mathias Poensgen, Clinical Subject Matter Expert and Product Manager at ArisGlobal, will present at the 7th Trial Master File Summit, scheduled for January 16-18, 2018 in Orlando, Florida on the topic “Achieve Business Success and Inspection Readiness with an eTMF.

“In the march toward streamlining processes, lowering costs and gaining improved efficiency, paper-based Trial Master Files (TMFs) stored in numerous secure file cabinets have given way to eTMFs, which are largely based on electronic document management systems (DMS) implemented as a stand-alone application,” says Mathias. “Yet, as evidenced by critical findings during audits and inspections, electronic Trial Master File (eTMF) are failing more frequently than paper-based counterparts and are deemed incomplete or not accessible to the inspector.”

Mathias’s presentation will help to show attendees how to:

  • Take eTMF beyond document management and inspection readiness
  • Identify business processes and stakeholders who are impacted by eTMF
  • Devise eTMF architecture and operations to support business processes
  • Look at possible engagement strategies for internal allies to ensure that your architecture is eTMF is informed
  • Consider governance practices that ensure that eTMF is being analyzed and used for a strategic purpose
  • Educate and train staff to ensure adherence to what they may consider unnecessary complexity

Mathias works closely with pharmaceutical companies and CROs to assist them in improving business processes, increasing efficiencies and lowering their costs in the area of clinical operations and clinical data management. He previously worked for more than 10 years in the pharmaceutical industry in various positions in clinical operations, project management, business process management and clinical IT.

In addition, Mathias is a key member of the clinical team instrumental in the product management of LifeSphere® Clinical, ArisGlobal’s cloud-based platform for clinical operations and clinical data management that leverages industry standard practices and cognitive computing to efficiently automate core business processes.

For more on this topic, read Mathias’s white paper, Understanding True eTMF Requirements.