Celegence’s Center of Excellence is designed for long-term symbiotic partnerships. With the CoE model, your project manager can leverage Celegence’s expertise as an extension of your team for various activities such as medical writing and data management.

You will maintain complete flexibility in deliverable prioritization with the confidence of a consistent and fully trained team. As a global team of industry experts and consultants managing our CoE model, the flexibility and oversight will effectively improve your quality, efficiency, and compliance.

Entrusting your compliance work to a partner can effectively help you achieve your business goals by:

  • Adapting to fluctuating volumes of work
  • Producing consistent and predictable high-quality deliverables
  • Designating a single point of contact for project management oversight
  • Leveraging expertise in all current global regulatory changes and trends
  • Providing support throughout the product life cycle by managing regulatory milestones

We offer an array of services for your team to leverage Celegence’s CoE. These services are based upon our clients’ needs, from CER/CEP writing and SOP template creation & management, to publishing and submission support for PMCF reports, among others.

Center of Excellence Process

At the core of our Center of Excellence Process is Collaboration so that there is transparent client oversight throughout the partnership:

Advantages of the CoE Model

  • Predictable budget forecasting
  • Operates as an extension of your team for regulatory compliance activities
  • Cost effective business operations
  • Flexible resource allocation, based upon current and future business needs
  • Prepared team ready to address peaks in volume
  • Availability around the clock with both onshore and offshore resources

Frequently Asked Questions

What happens when a major project deadline arises?

In order to provide reliable support for our clients’ ever changing regulatory needs, we maintain a bench strength of 20%.

What is a typical duration of engagement?

Our initial engagements for utilizing a CoE model typically range between 3-5 years. However, we do offer more flexible agreements based on your needs.

Will I be working with the same Celegence team members?

In order to provide the best fit for your organization, we allocate the most relevant and experienced resources to your project. We aim to maintain this dedicated team for the duration of the partnership.

Do you provide ongoing training?

Complete training and quality management are included in the project scope of all CoE engagements. Training is provided to new team members for process or procedural changes related to the scope of work.

How do you provide status updates?

For a typical engagement, we have weekly meetings with the project team to connect on shorter term milestones and provide status updates. Monthly and/or quarterly governance meetings with stakeholders to provide greater visibility into your project’s key milestones.

Of course, we are flexible to our clients’ preferences and involvement.

Contact Us

We encourage you to reach out for additional information related to your specific regulatory needs and how your team can benefit from Celegence’s CoE.

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