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.
National and international clinical trial registry services
Our comprehensive services for clinical trial registries include:
- Protocol registration*
- Clinical trial record data entry and maintenance support for registries*
- Results disclosure**
- XML generation for safety data
- Protocol and SAP redaction
- 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 obligations
- Regularly monitoring progress and mitigating risks encountered
Redaction and anonymisation services
We offer end-to-end support for redaction and anonymisation:
- Assessment of source documents for PPD
- Re-identification risk-assessment
- Preparation of an anonymisation plan
- Identification of CCI
- Literature search to confirm CCI
- 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 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
Transparency regulatory consulting
Our comprehensive understanding of transparency regulations and in-depth experience in this area for the past 15 years allows us to provide expert advice and unique insights on dealing with challenging situations related to CTT.
Click here for more information on our consulting services.