Case Study 5

TFS involved in European global customer’s pre-launch activities

SITUATION

TFS was requested to prepare and conduct a Late Phase global proposal to support the pre-launch activities of two products in different Therapeutic Areas. This proposal was included in the European Strategic Action Program as part of the products’ Marketing Plan.

CHALLENGES

  • Offered different Late Phase study proposals considering different scenarios (type of study, target of population and specialist) ensuring alignment with the customer’s established strategic plan
  • Provided valuable scientific study designs in order to enhance the product and/or therapeutic indication knowledge during the pre-launch phase of products
  • Delivered an integrated solution to meet the client’s needs  involving different company stakeholders
  • Ran the International Late Phase projects within the limited timelines due to products’ launch, despite challenging recruitment and a restrictive inclusion criteria

TFS SOLUTION

  • TFS’ multidisciplinary team’s expertise was combined to build the global proposal (scientific, biostatistics and clinical operations) including different study designs
  • TFS’ European coverage with team allocation close to client headquarters and affiliates ensureda strong and solid collaboration
  • After analyzing the different proposals, two Non Interventional studies involving 10 European countries and 1200 subjects in 120 sites was proposed    
  • Feasibility studies were conducted to identify the most suitable countries and sites to be involved
  • Ensured recruitment rates throughout the studies by close follow up of countries and sites performance and implementation of ad-hoc action plans when required

CLIENT ADVANTAGE

  • TFS as a full service CRO provided a combined solution by designing and delivering these late phase studies across Europe aligned with the customer strategy.
  • TFS expertise and know-how in International late phase settings ensured successful delivery of the projects.