+ Phase-I-support-Programme-management

Programme management

We have a comprehensive programme management service with a full range of functions that can be combined to meet a customer’s individual needs regardless of size or complexity. Our aim is to develop a collaborative partnership with the flexibility to define the type and extent of service required.

Introduction

Each project is placed under the care of a Programme Manager who is the primary contact for customers. The Programme Manager can also enable direct communication with study directors and other study scientists. This single point of contact means that entire programmes can be expertly co-ordinated, including external phases conducted at third-party facilities.

Our Programme Managers have ready access to all of the scientific resources within the company, including internationally acknowledged experts who can assist in the resolution of scientific, technical and regulatory issues.  They have many years of experience in the industry and have proven skills in the management of complex multi-disciplinary and multi-location programmes. They are fully supported by an infrastructure designed to ensure good communication and an effective team-based approach.

Our aim is to provide a comprehensive, responsive and professional service without equal in the contract research industry. We aim to become an extension to our client’s own project team, providing the following services.

Scientific Management and Consultancy

  • Programme design and non-clinical strategy
  • Study design and study plan development
  • Scientific overview of new method development, validation and implementation
  • Scientific Consultancy and problem solving
  • Scientific peer review
  • Expert overviews

Programme Management Functions

  • Provision of single point of customer contact
  • Enquiry handling, including preparation of project proposals
  • Co-ordination and scientific review of programme and study designs
  • Co-ordination of study plan and contract preparation
  • Study set-up and initiation at third party facilities
  • Scheduling the programme to meet defined deadlines
  • Facilitation of communication between the customer and functional groups within Sequani and at third party facilities
  • Progress chasing to ensure that all elements of the programme are performed to  agreed timescales
  • Monitoring and management of programme elements being performed at third party facilities
  • Periodic programme reviews and updates
  • Periodic scientific review of the programme and preparation of expert summaries
  • Facilitating review of third-party reports
  • Periodic involvement in/presentation to customer project team meetings
  • Enquiry handling
  • Co-ordination and scientific review of programme and study designs
  • Co-ordination of protocol and contract preparation
  • Standardisation of protocol formats for functional groups within Sequani and at third party facilities
  • Scheduling the programme to meet defined deadlines
  • Facilitation of communication between the Customer and functional groups within Sequani and at third party facilities
  • Periodic involvement in/presentation to Customer Project Team meetings.

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