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Clinical Project Management & Sponsor Oversight

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Clinical Project Management

Your single point of contact to LINK’s expert team

A highly skilled Clinical Project Manager (CPM) is a pre-requisite for a successful clinical study. Our CPMs are extensively trained and competent, with experience in managing cross-functional teams executing international Phase I-IV studies as well as medical device/IVD studies from initiation to completion.

The CPM will act as the main point of contact internally and externally. They will always work to make sure that deliverables are completed with high quality, on budget and according to timelines as well as to the customer’s satisfaction.

Our CPMs can provide Sponsor Oversight, supporting Sponsors in meeting their responsibility (ICH E6, GCP) in ensuring adequate quality, data integrity and regulatory compliance by providing risk-based, documented oversight of outsourced trial activities. We also provide support with the procurement of CROs and vendors.

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Our strategic partnership

As part of our strategic partnership, we will carefully assign a CPM perfectly suited to address your specific challenges. They will liaise with experts in medical writing, biostatistics, toxicology, CMC, data management, regulatory affairs, market access, medical monitoring, and pharmacovigilance as needed.
LINK Medical has CPMs that work internationally in studies performed in Europe, US and beyond. The Clinical Project Management team has a long track record of reliable support for a diverse range of projects regardless of their size, phase, therapeutic area, or complexity.

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Project Management Services

  • Internal, vendor and sponsor communication and with oversight for clinical trials
  • Negotiation and finalizing contracts with vendors (MSA, WO and DPA)
  • Responsibility for the budget including managing out of scope
  • Proactive Risk Management as a key activity
  • Oversight of Risk-Based Monitoring activities
  • Issue escalation processes are implemented at all stages and enable us to confidently solve any issue that may arise throughout the study, including governance support
  • Close collaboration with our QA department, ensuring your clinical studies pass audits and inspections
  • Development of project plans and timelines – an integral part of good project management within LINK Medical
  • TMF oversight always ensuring inspection readiness
  • IMP supply management
  • Managing Protocol Deviations throughout the study
  • Oversight of study team training and hand-over
  • Management of back-end services including clean file and up until clinical study/ investigational report
  • Develop charter and organize Safety Review Committee Meetings when applicable
  • Sponsor Oversight services - to support Sponsors with independent, risk-based oversight of outsourced clinical trial activities, ensuring compliance, data integrity and quality.

Get in touch

How can we help you?

Contact us and we will tell you more