,Clinical Data Transparency Initiative Services - Overview
Transparency in clinical trials is becoming a vital function within sponsor and academic institutions, reflecting its growing significance across the pharmaceutical, biotechnology, and medical device sectors. Understanding data anonymization techniques and tools is essential to comply with growing healthcare regulations.
Freyr’s clinical data transparency initiative services team has vast experience supporting disclosure registry services and data transparency activities across various regions.
Our Disclosure Registry 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 in responding to and meeting 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, such as policy guidance for Health Canada Public Release of Clinical Information (PRCI), EMA Policy 0070, and Policy 0043 execution.
In addition, our Data Transparency Initiative Services team could also support the preparation and review of Plain-Language Summaries intended to make the clinical study results accessible to various stakeholders of the healthcare industry in easy and simple language.
Clinical Data Transparency Initiative Services
- 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 clinical data 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, reviewing, and preparing plain language study results summaries 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, such as policy guidance for Health Canada Public Release of Clinical Information (PRCI), EMA Policy 0070, and Policy 0043 execution.
- Complete understanding of data redaction, anonymization, and/or pseudonymization of documents for Patient Personal Data (PPD) and Company Confidential Information (CCI)
- Well-versed with the identification of PPD and CCI in clinical documents (CSR, clinical overview, and clinical summaries) and anonymization techniques and tools
- Ensure on-time delivery of the redaction proposal package while maintaining the highest standards of quality
- Expertise in disclosure registry services and data transparency across diverse regions, ensuring the sponsor stays compliant and ahead in data transparency initiatives.
