Operational Planning & Delivery

The Right Technology in the Right Operational Strategy will Drive Massive Results

 

The ability to manage risk and understand the impacts of technology within your operational delivery plans is critical to the success of any study. In context of decentralized clinical trials, the need to manage and understand risk is even greater, as the industry looks to access a more diverse patient population while providing greater flexibility.

Technology offers the ability to reach more people, but it is the operational plan around the use of that technology that will ultimately make the difference between success and failure.

Vertocol’s experienced team can help you think through the operational concerns and develop a strategy that will work for your specific use case.

 

Technology Impact Assessment

 

Depending on how you define risk, each company has a different approach and philosophy of how to integrate tech into their studies. This risk varies based on the technical, cultural and regulatory factors at play for any given study.

With Vertocol’s depth of experience, let us help you through understanding the implications across your DCT, Hybrid and Traditional studys. Work with Vertocol to assess:

  • Tech readiness of target platforms/vendors

  • Configurability of tool and risk identification

  • Audit readiness

  • The status of the quality documentation

  • Product readiness and feature gaps

  • 21 CFR Part 11 / GDPR compliance

  • Integration readiness

    • Potential risks and mitigation strategies

  • Training needs and support


unsplash-image-RLw-UC03Gwc.jpg
 

Technical Project Manager

 

Need help from an experience team implementing technologies into your Clinical Studies? Let Vertocol help you through the process with our experienced Technology Project Management experience.

Engage experienced staff who can help you implement a new technology into your study and act as part of your operational delivery team to manage technical and operational needs. Vertocol team members are:

  • Able to bridge the gap between technology and clinical delivery

  • Skilled at providing guidance on regulatory submittal packages

  • Trained in best practices for documentation collection

    • Project plans

    • Decision logs

    • Requirements documentation

    • Vendor management

  • Trained in agile delivery methodology

  • Able to manage third-party vendors and deliverables such as EDC, IRT, translation, and eCOA validation

  • Trained in HIPAA, 21 CFR Part 11, GDPR, and GCP regulations

  • PMP certified

  • Experts in the clinical industry

unsplash-image-nNMBa7Y1Ymk.jpg
 
 

Study Rescue Support

 

 Partner with an engaged SME to help develop a comprehensive strategy for implementing technology into a study rescue

  • Review country regulations

  • Assess tech readiness of target platforms/vendors

  • Assess configurability

  • Check audit readiness

  • Conduct UAT

  • Review quality documentation

  • Review product readiness

    • Feature gaps

  • Check integration readiness

    • Potential risks and mitigation strategies

  • Determine training needs and support

  • Create data migration strategies

  • Review data collection modalities

  • Provide site support recommendations for training

unsplash-image-FlPc9_VocJ4.jpg