Regulatory Compliance Project

Company: a leading diagnostics company

Business Objectives:

  • Comply with new biobank regulation of Jan 9th, 2018.
  • Implement a sustainable quality framework to conduct biobank activities and related practices.
  • Register as decentralized hub of an existing biobank.

Challenges Client:

  • Loss of new and existing scientific collaborations if human research doesn’t comply with biobank regulation before May 1st
  • Risk of unnecessary costs, inefficient way of working when biobank framework is not properly established.

Our solutions:

Project Management services using in-house developed ‘Fast Track To Value’ project methodology (6 process groups):

 

1.DEFINE PROJECT

  • Creation of biobank project charter endorsed by SLT (Senior Leadership Team).

 

2.PLAN PROJECT

  • Collection and prioritization of biobanking requirements.
  • Translation requirements into deliverables, resource allocation by use of RACI model.
  • Development of adaptive timelines.
  • Creation of project (sub)plans and performance indicators.

 

3.EXECUTE PROJECT PLAN

  • Coaching the team through the project work.

 

4.CHANGE PROJECT

  • Adjustments based on analysis of work performance data.

 

5.REPORT PROJECT STATUS

  • Transparent reporting on project progress towards SLT.
  • Creation of project dashboards.

 

6.CLOSE PROJECT

  • Final acceptance of project deliverables by client.
  • Collection of lessons learned, document archiving.

 

 

Results / Added Value:

  • Delivery on the business objectives within the set boundaries on scope, time and cost.
  • Introduction of a scalable, flexible project management delivery method.
  • Proven value and lessons learned for similar projects, such as the implementation of IVDR or ISO13485.