Clinical Development

Clinical Development organisations continue to be pushed to reduce costs and increase productivity while keeping pace with constantly changing internal and external environments. It is, therefore, necessary for Clinical Development organizations to:

  • Make capability investment decisions to maximise productivity and take advantage of global sourcing opportunities
  • Align clinical development portfolio with corporate objectives and assure active management of portfolio risk and sustained value creation
  • Manage integration and on-going activities as part of the increasing number of acquisitions and alliances

Kinapse helps its clients to lay the foundation of successful clinical programmes by:

  • Assembling and managing development plans to ensure projects are de-risked early and cost-effectively, and that cross-functional dependencies are managed (for instance in clinical supplies) and studies are clearly aligned with project objectives
  • Assuring clinical studies are managed as a coherent whole, with each study contributing to specific program objectives and no more, avoiding unnecessary data collection, analysis complexity or reporting risk

At Kinapse, we work with our clients to:

Successfully integrate post mergers

  • Well-defined operating strategy in place supported by redesigned processes, roles and responsibilities, and interfaces
  • Manage change programs
  • Embed a culture of continuous improvement

Make global expansion work

  • Expansion into emerging markets with a clear understanding of customer requirements
  • Effective resource management globally with adequate support services in place

Exploit alternative development models

  • New development paradigms to speed up development for innovative drugs
  • Adaptive trial designs enabling earlier and improved evaluation of benefit and risk

Effectively engage scientific community

  • Improved relationships and management of KOLs and investigators
  • Insights and visibility to ad boards, congresses and related symposia

Improve internal performance analysis and reporting

  • Effective solutions to trigger informed decision-making
  • Improved internal efficiency to produce regular reports

Consulting:

  • Post-merger integration design and implementation
  • Global, regional and local clinical operations strategy development and organisation-design
  • Program team roles and responsibilities definition
  • Process and systems redesign and implementation support
  • Strategic resource management and resource modelling
  • Identification of opportunities for efficiency and/ or productivity gains
  • Project management of change initiatives
  • Setting up a continuous improvement culture
  • Real World Development (RWD) programs design and implementation
  • Sourcing strategy and implementation support
  • Investigator and KOLs relationship management
  • Performance management, analysis and reporting

Outsourcing:

  • Medical Writing

The following are Senior Members of our Clinical Development team: