Making clinical research crystal clear

Clinical trial transparency services

Clinical trial transparency (CTT) obligations 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 over our decades of experience in this area.

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Our comprehensive services for clinical trial registries include:

Protocol registration (global and country-specific registries e.g., ClinicalTrials.gov, EU CTIS, Kenya registry, and JapicCTI)
Clinical trial record data entry and maintenance support for registries
Results disclosure (global and country-specific registries e.g., ClinicalTrials.gov, EU CTIS, Spanish ReEC, and Argentina National registry of health research)
XML generation for uploading adverse event data on ClinicalTrials.gov
Redaction of protocol and statistical analysis plan
Liaising with regulatory/registry points of contact

We offer end-to-end support for redaction and anonymization to comply with growing data and document sharing requirements (European Clinical Trial Regulation (EU CTR) 536/2014, EMA Policy 0070, EMA Policy 0043, Health Canada Public Release of Clinical Information (HC PRCI), and voluntary data sharing requests).

Our services include:

Liaising directly with Health Authorities
Assessment of source documents for protection of personal data (PPD)
Re-identification risk-assessment
Preparation of an anonymisation plan
Identification of commercially confidential information (CCI)
Validation of CCI through literature searches
Anonymisation/redaction of PPD
Redaction of CCI and preparation of justification table/proposed redaction control sheet
Preparation of the anonymisation report

Click here for more information on our redaction and anonymisation services

We offer end-to-end PLS services:

Plain language protocol synopses
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)

Click here for more information on our plain language services.