Business Areas


Select, implement and use technology and systems in compliance within Clinical Development

Clinical Development is characterized by bringing new innovative treatments to patients; this most often requires and is improved by using specific IT systems tailored for Clinical Development. Regulators and patients expect Biotech and Pharma to have full control of IT systems and being able to document and demonstrate compliance with regulatory expectations.

At Epista we are experts in delivering advice on use of technology within Clinical Development. We pride ourselves of having experts covering the full value chain – from laying the foundation withan IT Roadmap & Strategy to Search & Selection and implementation, validation and migration. We are fully capable of supporting any Clinical Development organization building, expanding or upgrading their IT systems landscape.

Talk to an expert
Morten Nielsen
Principal Consultant


We deliver input to and build digitalization strategies for Clinical Development organizations; covering all departments like: Clinical Data Management, Biostatistics, Trial Management, Clinical Trial Supplies, Clinical Administration and document management.

With our broad knowledge in Clinical Development, we are capable of providing a holistic view on the selection and utilization of technology and systems – supporting client ambitions and delivering value.

Our services and deliverables are:

  • Ambition mapping – aligning expectationacross an organization
  • Building strategic IT Roadmaps covering Clinical Development or even broader
  • Ensuring strategic fit to other businessareas like Regulatory Affairs, Quality and Safety
  • And more

IT System Implementation

New IT systems in Clinical Development are required to fulfill regulator expectations in terms of being compliant. Equally important, new systems must support client ambitions and future business processes. At Epista, we have experts in place to ensure both compliant systems implementation as well as best fit to current and future business processes.

IT System Implementation services include:

  • Project preparation; Test &Validation strategy; project planning
  • Test execution
  • CAPA and deviation management
  • Business process creation/updates
  • Systems Admin procedures, practices and templates
  • Vendor Management
  • And more


We ensure continuous operation and evolution of operational IT systems. New cloud-based IT systems often come with frequent updates and new features; these must be assessed and validated before they can be adopted by the Lines of Business. As well, employees must be trained in new features and procedures must be updated.

At Epista, we have skilled experts covering many different IT systems and through our Managed Operations services we are always available to support updates to system or to deliver end-user support and training.

Operations services can include:

  • Creating and establishing an operationsand maintenance model
  • Ensuring best practices for industrycompliance
  • Change and release management
  • End-user support and training
  • And more

Data and Document Migration

Implementing and replacing IT Systems as well as the acquisition of new products involve migration of data and documents. This must be done in a compliant way to ensure data integrity is maintained and can be documented.

Through our validated migration tools and processes, Epista is capable of delivering state-of-the-art migration services. Our technical services team have performed migrations of data and documents formany different clients and systems. The validated migration service provide a transparent and robust approach ensuring that all data and documents can be injected correctly into the new/updated system.

Data & Document Migration services include:

  • Data and document source assessment and analysis
  • Migration planning
  • Migration execution and documentation
  • And more

Our Customer Cases

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We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.