Making clinical research crystal clear
Clinical trial transparency services
- 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.
Services offered
National and international clinical trial registry services
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
Transparency compliance monitoring
Study tracking and CTT compliance monitoring is integral to all CTT activities. We take full accountability for compliance by:
- Assessing CTT obligations at the study or marketing authorisation application (MAA)-level
- Creating robust plans to meet the transparency obligations
- Regularly monitoring progress and mitigating risks encountered
Redaction and anonymisation services
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
Plain language summary (PLS) 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.
Transparency regulatory consulting
Our comprehensive understanding of transparency regulations and in-depth experience in this area for the past 17 years allows us to provide expert advice and unique insights on dealing with challenging situations related to CTT.
Experience of our experts
Have been working in CTT for over two decades
Deep understanding of current and emerging global regulatory requirements
Extensive experience working with regulatory/registry reviewers
Completed thousands of transparency deliverables across all therapeutic areas and phases of drug development
Significant contributions to industry forums and the development of regulations
Produced publications, white papers, and posters on CTT developments