Customer/project Understanding

Context & challenge

In 2018, the customer – after having relied on PLG since  2010 for covering their routine PV activities – launched the project in order to support its internal resources.  The collaboration with this international Company (based in EU, USA and China) grew along with the changes in the needs of the client: from simple QPPV services to case processing to medical and PV writing and assistance in clinical development.

Current scope

  • Immunomodulating drug, presently registered as vaccine booster and in development as an immune enhancer in Oncology and- recently – in COVID-19 infections.
  • The program is in place since 2019 with the objective to support all PV related activities worldwide, both pre- and post-registration.
  • The number of processed cases increased exponentially in the past few years.
  • The structure has been adapting to client reorganizations with important changes in the scope and volume of activity but always maintaining a high level of the quality of the service, working in close connection with the Quality Group and the Senior Management of the Customer. Medical Review constitutes an essential part of the activities performed and is integrated at all stages.

Customer benefits

On-Time-Delivery (OTD) and Right-First-Time (RFT) KPIs.

Both Medical Reviewers, Coordinators and Senior/ Junior MDOs interacting within the same team.

Continuous improvement, in collaboration with the client’s Quality department with the objective to anticipate issues and implement or verify efficiency of action plans.

Integrated, cost/effective and flexible process.


10 Headcount – 1 coordinator – 1+1 Medical Reviewers

Solution provided by PLG

Our end-to-end global outsourcing model‎

Year after year the PLG team (now called Global Safety Data Unit in Client’s own SOPs) has been growing to become an autonomous decentralized structure with stronger on-site management and coordination. This allowed  to successfully take in charge the management of the back-up system, newcomers on-boarding, workload management, distribution and forecast and continuous improvement of the service delivered, as witnessed by KPIs.

PLG success factors

Involvement of Medical Reviewer(s)- when needed –  in all stages of the process, from Clinical Trial Planning to “data tools” evaluation to daily case management assures both cost/effectiveness and consistency in quality.

PLG adaptability to customer evolutions and growing autonomy resulting in time/cost savings for the customer.

Back-up management: activities maintained whatever missing resources or whenever workload increased unexpectedly (e.g. with new COVID trials).

New internal and external resources training in autonomy; customer partners qualification & training.

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