Clinical Operations

Clinical study delivery against plan, and effectively managing investigators and CROs, are top priorities for Clinical Operations. The key to success is to lay stress on developing focused protocols which are fully aligned with the program plan, and feasibility tested to ensure that protocol amendments are minimised and study planning set up for cost-effective completion. The key areas to focus are:

  • Countries: selecting high priority countries for study conduct, balancing commercial, clinical, regulatory, legal, financial and compliance requirements and providing transparent allocation processes which enable the country strategy to be implemented
  • Sites: bringing a fact-based approach to site selection to eliminate non-performing sites and enable site set up in order to deliver on feasibility targets
  • Investigators: achieving ‘joined-up’ relationship management such that quality of study conduct and sponsor loyalty is maximised in a long-term win-win relationship
  • Patients: ensuring that subjects are engaged early in clinical strategy and adopting best practices in enrolment strategy and clinical conduct to assure clinical safety

Kinapse provide services covering entire clinical operations from study design to performance management.

Design studies able to meet objectives

  • Effective upfront feasibility including evaluation of patient, investigator, resourcing, supplies and other criteria
  • Concise protocols written with desired end points in mind

Improve site productivity

  • Best practice country and site selection criteria
  • Best practice subject recruitment and retention practices

Enhance external relationships

  • Improved relationships and management of investigators
  • Effective criteria for outsourcing vendors screening and selection

Provide cost-effective resources for late stages

  • Outsourced Medical and Report writing services
  • Clinical Trial Disclosures

Improve internal performance analysis and reporting

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

Examples of projects include:

Consulting:

  • Process and systems redesign and implementation support
  • Strategic resource management and resource modelling
  • Study team roles and responsibilities definition
  • Trial feasibility and site selection
  • Investigator relationship management
  • Strategies for subject recruitment and retention
  • Outsourcing strategy and implementation support
  • Performance management, analysis and reporting

Outsourcing:

  • Medical writing including protocols, study reports and manuscripts
  • Clinical trial disclosure support
  • Investigator Brochures
  • SOPs writing

The following are Senior Members of our Clinical Operations team: