Outsourcing Management 360 (OM360 Ltd)

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  • Compliance
  • Contract Resource
  • Outsourcing Solutions
    • Outsourcing Strategy
    • Search & Seletion
    • Start-Up & Scope
    • Oversight & Compliance
    • Contract Mgt.
    • Outsourcing SOPs
  • Training
  • Expertise
  • Contact

Oversight, Relationship Management & Compliance

​ISSUES:
  • Is a formal oversight structure or process always required?
  • Who is responsible for managing provider oversight?
  • ​​How can Issues be managed constructively but costs still controlled?​​
  • Can invoice management support financial compliance?
  • Is the Provider responsible for Investigator Site payment and financial compliance?
Oversight of clinical performance
This not an optional extra when outsourcing clinical studies. The 'owner' of the investigational medicinal product remains ultimately responsible for study conduct when it is performed by a Third Party. (REFERENCE) The outsourcing process must include ongoing management of outsourced activities after the project starts and after the clinical procedures are completed.  OM360 provides pan-industry experience, standards and processes to ensure operational control alongside regulatory and financial compliance.​

Relationship management is as important in a single study as a strategic partnership.
Whether basic communication planning and issue handling through to long term Partnership and Program-level Governance at Corporate Level a good working relationship, is a marriage that needs effort to work and last. Whichever scale is appropriate, early setup of rules for interaction are essential to promote transparent, open and constructive communication and operational collaboration. ​
Responsibility for oversight is shared but requires leadership. 
Effective provider oversight requires a is an increasingly visible requirement in outsourced studies. Beyond the initial selection and contracting, oversight of financial conduct needs to be integrated into the performance management and governance of Third Parties, ensuring transparency of cash flow, maintaining cash neutrality, and continuity of Fair Market Value for services provided to Providers and subcontractors and Investigator Sites
Financial compliance is an increasingly visible requirement in outsourced studies. Beyond the initial selection and contracting, oversight of financial conduct needs to be integrated into the performance management and governance of Third Parties, ensuring transparency of cash flow, maintaining cash neutrality, and continuity of Fair Market Value for services provided to Providers and subcontractors and Investigator Sites
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