Data Transparency Initiatives - Overview
Clinical trial transparency is quickly emerging as a critical function within sponsor and academic organizations, as its importance in the pharmaceutical, biotechnology, and medical device industries increases. Understanding data anonymization techniques and tools is an important part of adhering to increasing regulation.
Freyr’s Medical writing team has vast experience supporting disclosure registry services and data transparency activities across various regions.
Our Disclosure registries services include:
- Prepare and update clinical trial protocols and results disclosures within the required timeframes for global registries (ClinicalTrials.gov), EudraCT, ENcEPP, ISRCTN, etc.
- Prepare and update the clinical trials protocol disclosures on ClinicalTrials.gov.
- Support the Sponsor team to respond to and meet global disclosure mandates and regulations.
Our Data Transparency services include:
- Redaction, anonymization, and/or pseudonymization of documents for Patient Personal Data (PPD) and Company Confidential Information (CCI)
- Preparation of the complete justification report
- Ensure compliance with various Regulatory guidelines and requirements. E.g. policy guidance for Health Canada Public Release of Clinical Information (PRCI), EMA Policy 0070, and Policy 0043 execution, etc.
In addition, Freyr Medical writing could also support the authoring, review, and preparation of Plain Language Study Results Summaries intended to make the clinical results of studies accessible to patients, healthcare providers, caregivers, researchers, and general audience in a language that is easily understandable and simple in the description.
Data Transparency Initiatives
- Preparation and update of clinical trial protocols and results disclosures within the required timeframes for global registries (ClinicalTrials.gov), EudraCT, ENcEPP, ISRCTN, etc
- Preparation and update of the clinical trials protocol disclosures on ClinicalTrials.gov.
- Support the Sponsor team to respond to and meet global disclosure mandates and regulations
- Support in submission of the redaction proposal document package (CSR, clinical overview and clinical summaries) by aligning with deliverable timelines
- Preparation of redaction, anonymization, and/or pseudonymization of documents for Patient Personal Data (PPD) and Company Confidential Information (CCI) as per policy guidance for Health Canada Public Release of Clinical Information (PRCI), EMA Policy 0070, and Policy 0043 execution, etc.
- Preparation of the complete justification report
- Support in preparation of anonymization report
- Support in authoring, review, and preparation of Plain Language Study Results Summaries intended to make the clinical results of studies accessible to patients, healthcare providers, caregivers, researchers, and a general audience.
- Ensure compliance with various Regulatory guidelines and requirements. E.g. policy guidance for Health Canada Public Release of Clinical Information (PRCI), EMA Policy 0070, and Policy 0043 execution, etc.
- Complete understanding of redaction, anonymization, and/or pseudonymization of documents for Patient Personal Data (PPD) and Company Confidential Information (CCI)
- Well-versed with identification of PPD and CCI in clinical documents (CSR, clinical overview and clinical summaries) and anonymization techniques and tools
- Timely delivery of redaction proposal document package with the highest standard of quality
- Expertise in disclosure registry services and data transparency across diverse regions, ensuring sponsor stays compliant and ahead in data transparency initiatives.
