Making clinical research crystal clear

Consulting services

The challenges that life sciences organisations face are complex and require careful management of interdependencies. Solving these also requires collaboration across an organisation’s functions and departments so that synergies can be leveraged. For example, patient engagement initiatives can give clear insights into patient communication activities downstream. We also understand that the challenges and solutions may differ between larger pharmaceutical companies and smaller ones. Our experts are experienced in working with different operating models and can provide the most appropriate and relevant approach for each customer.

Krystelis’ operational services are based on a comprehensive understanding of current and upcoming regulatory requirements across all regions in which our customers operate. Several of our team members are recognised as global subject matter experts in their fields, particularly in clinical research transparency and medical writing. They contribute to the shaping of future regulations by producing thought papers, participating in industry forums, and commenting on proposed guidance from health authorities.

Krystelis is ideally positioned to provide regulatory consulting services in our areas of expertise, either alongside our operational services or as a standalone engagement.

These services could include:
  • Assessing how upcoming regulatory changes could impact business processes, for example, the introduction of EU–CTR 536/2014
  • How to adapt processes in the most efficient way to ensure compliance with regulations
  • Process design, including writing SOPs
  • Implementation plans and change management including training on new regulations and associated processes
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