Project Management and Planning

A project plan is always subject to changes. Being able to cope in a pro-active way (risk based management) with these changes is one of the major strengths of our teams resulting in considerable cost and time savings for your projects.

Our project management (PM) team works hand in hand with the sponsors study team to ensure smooth running of the clinical trial.

Our PM team works effectively and diligently to manage the clinical trial to the required timelines, within study budget and with the highest possible quality output. We will work with the sponsors study team on all aspects of the clinical trial from study planning to closeout and final reporting to help the project succeed.

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IN SUMMARY WE PROVIDE :

  • Primary liaison (lead point of contact) with sponsors study team
  • Team motivation and management (internal and external)
  • Project timeline/milestones management
  • Budget/contract management
  • Frequent and timely project status reporting
  • Provider management and follow up

MORE IN DETAIL PROJECT RELATED ACTIVITIES CAN INCLUDE :

  • Study Protocol, Informed Consent and Case Report Form Design
  • Identification of investigators, qualification and selection of investigational sites.
  • Preparation of project timelines and provision of corresponding resources plans.
  • Outline of study specific patient recruitment strategies and programs.
  • Organization of meetings with investigators and Sponsor.
  • Negotiation in conjunction with sponsor of contracts/fees with investigators and other parties at the investigational site.
  • Preparation, assemblage and maintenance of study documentation, study binders, investigational products, clinical supplies, etc
  • Preparation of Training Materials/Site Training
  • Control of communication with study team by means of team meetings, internal teleconferences, periodic status reporting and e-mail updates.
  • Constant review of TM’s work to assure highest standards and consistency
  • And much more!

Interested? Get in touch!