Making clinical research crystal clear

Other services include

Technology

Consulting

Administrative Services

Technology

The impact of technology on drug development activities has never been greater. Krystelis continues to invest in and apply technology solutions that enhance the value of our service offerings. These are internally developed or accessed through our partners.

Technology

KrystelisClearAI

The power of AI to transform business activities is unquestionable. Krystelis has harnessed the potential of large language models (LLM) to develop and implement a tool that can be customised to create consistently and efficiently any type of plain language document aimed at a particular target reading level.

KrystelisClearPM

Robust project management underpins excellent service delivery. This includes timeline and resource management, cross-team communication and generation of appropriate performance indicators. Krystelis has deployed a web-based tool developed using a commercially available platform that manages these aspects through a simple interface. Access to this is provided to clients who can interact with our teams and monitor progress against deliverables and KQIs/KPIs in real time.

Document anonymisation

While Adobe Acrobat is suitable for redaction of documents, the more complex transformation approach to anonymisation benefits from the application of a purpose-built tool. The Krystelis team has for several years worked with one of the leading providers of anonymisation technology and we apply this solution to relevant dataset and document anonymisation projects.

Consulting services

Krystelis’ services are based on our team’s comprehensive understanding of current and upcoming regulatory requirements across all regions in which our clients operate. Several of our team members are recognised as global subject matter experts in their fields, for example, in clinical trial transparency and plain language writing. They contribute to the shaping of future regulations by producing thought papers, participating in industry forums, and contributing to proposed guidance from health authorities. We apply this knowledge not just to deliver our services, but also to help our clients build and adapt their internal processes in response to the continuously evolving regulatory landscape.

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

Assessing how regulatory changes 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 and templates

Implementation plans and change management including training on new regulations and associated processes

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Administrative services

At Krystelis, we deliver high-quality services cost-effectively. Our model is ideal for the delivery of administrative tasks that are often inefficiently delivered by your scarce and expensive internal resources. Many of your administrative activities could be delivered more effectively in partnership with us. Areas of opportunity include, but are not limited to:

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Systems data entry and administration, for example

  • Clinical Trial Information Systems (CTIS)
  • Clinical Trial Management Systems (CTMS)
  • Learning Management Systems (LMS)

Mailbox monitoring, triage, and workflow management

  • Investigator-Initiated Study Management and e-Requests Management
  • Query Handling from Investigators, Health Care Providers (HCP), or Patients (e.g. patient enquiries received through clinicaltrials.gov)

User acceptance testing (UAT)

  • Work with your system owners to develop UAT scripts
  • Execute UAT scripts

Benefits of outsourcing administrative services to Krystelis

Expensive internal resources can focus on more strategic activities

Access to a scalable and flexible solution to meet variable workload demands

Highly collaborative and transparent delivery model

Quality checks are built into every process step

Our ability to accelerate timelines for urgent deliverables

Our continuous improvement approach increases the value of the service over time

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