Whether we like it or not, inspections are a crucial part of clinical trials. It...
Phlexglobal has announced the appointment of Karen Roy to chief strategy officer.
In 2007, highly-respected trial master file (TMF) thought leader Karen Roy joined Phlexglobal as chief business development officer and since 2015 she has led Phlexglobal’s global client solutions team.
Karen’s clinical and electronic data capture (EDC) background has been instrumental in establishing Phlexglobal’s electronic trial master file (eTMF) initiative to promote, develop and implement support of client eTMF systems, as well as Phlexglobal’s eTMF solution PhlexEview.
As chief strategy officer, Karen’s focus will be on the strategic priorities for the company. Karen will focus on key clients, contract research organisations (CRO), TMF expertise and PhlexEview to support the continued strong growth of Phlexglobal. This will include:
- Communicating Phlexglobal’s product strategy, vision, and expansion as a PhlexEview evangelist / educator / supporter
- Promoting dialogue on regulatory trends for inspection readiness based on Phlexglobal solutions
- Establishing a world class model for CRO adoption of PhlexEview and supporting ongoing relationships for the CROs who work with PhlexEview for their clients
- Continuing as an executive liaison with key clients
Karen will also continue to co-chair the TMF Reference Model initiative and chair the Steering Committee, standardising TMF contents, naming, structure and metadata globally.
Phlexglobal has also announced the promotion of Marion Mays to vice-president of client solutions and quality assurance. Marion’s team has further expanded the range of its subject matter expertise-driven resources and consultative services.
The client solutions and quality assurance division is chartered to help companies improve their business practices and TMF processes to achieve quality and excellence in the administration and management of all their TMF documentation data.
Phlexglobal CEO Rick Riegel commented “Karen has long since been at the centre of our success and we thank her for her leadership of client solutions. Within her new role, Karen’s tremendous strategic insight and experience will help drive our business to the next level, while Marion’s promotion will ensure we continue delivering outstanding outcomes for our clients.”
Phlexglobal offers a wide range of trial master file (TMF) related services, supported by a...
Phlexglobal has announced that it is joining fellow experts at DIA’s eDM Clinical and Regulatory Operations Forum....
Phlexglobal's Client Solutions group offers expert consultancy, which leads to successful trial master file (TMF)...