Making clinical research crystal clear

Clinical trial transparency services

Clinical trial transparency obligations (CTT) are foundational to your company’s commitment to patient centricity. Achieving compliance with diverse and evolving global regulations is challenging and requires:

A deep understanding of how the regulations impact individual clinical studies and company processes.
The ability to apply this knowledge to create disclosure documents that are “right first time”.
Monitoring the progress of all disclosure documents across your clinical trial portfolio.

Krystelis offers comprehensive services to help you meet these obligations. Our proven approach has evolved during our decades of experience in this area.

Krystelis-Clinical-trial-transparency-services-Image

We offer end-to-end PLS services:

Plain language protocol synopsis
Plain language summaries for clinical trial results
Plain language summaries for publications
Implementing processes for PLSs
Health literacy review
Graphic design support (infographics and template design)
Comic or video formats of summaries
Review of material by a patient representative panel (patient panel review) or public representatives (non-scientific panel review)
Translation and dissemination

Click here for more information on our plain language services.

*Protocol registration and maintenance activities on international registries (e.g., ClinicalTrials.gov, EudraCT, and EU CTIS) and national registries (e.g., Kenya registry and JapicCTI)

**Results disclosure on international registries (e.g., ClinicalTrials.gov, EudraCT, and EU CTIS) and national registries (e.g., Spanish ReEC and Argentina National registry of health research)