Clinical Trial Transparency and Disclosure
Streamline your transparency processes for accurate and timely compliance with our deep regulatory expertise.
End-to-end expert support from protocol registration to results posting
Get hands-on help from our experts for the entire lifecycle of transparency activities using AI-enabled solutions. Our team of specialists will guide you through the complex landscape of global transparency requirements, ensuring compliance while establishing a patient-centric approach to clinical trials.
Registration and results
With specialists experienced in global registries and transparency requirements, we ensure accurate, timely disclosure of your trial protocols and results across all relevant registries. We are expert writers who understand the science, systems, and the laws behind clinical trial disclosure.
We don’t just manage registrations and results postings – we optimize them. We analyze complex source documents, extract clinical data points, and format submissions precisely to each registry’s requirements. Through accurate forecasting and meticulous attention to detail, we deliver excellence in both quality and timeliness, allowing your team to focus on core research priorities with complete confidence in your transparency and compliance.
Clinical trial disclosure transcends basic compliance; it shapes the public perception of your commitment to clinical practices and patients.
Our services include:
- Comprehensive Record Management: Meticulous maintenance and amendment updates aligned with diverse regulatory requirements
- Cross-Registry Harmonization: Expert verification ensuring alignment across multiple global registries
- Rigorous Quality Assurance: Independent quality teams perform thorough reviews to maintain compliance
- Strategic Workflow Management: Our experts oversee your processes to anticipate and meet deadlines
- Protocol and results posting on sponsor websites
EU CTIS submission support
We have deep expertise in EU Clinical Trial Regulations with extensive experience with CTIS submissions. Our specialists continuously monitor evolving requirements and can help you understand the technical requirements of the CTIS platform and the strategic considerations that drive successful submissions.
Our services include:
Document Processing
- Redaction: Protection of confidential information and personal data in Part I and Part II Documents for Initial Submission and subsequent modifications
- Plain language and translation: Generate plain language protocol synopsis and results summaries compliant with multi-language requirements across member states
Submission & Management
- Intermediate and Final Results Submission
- Submission of De-identified (redacted/anonymized) Clinical Study Report Post-Marketing Authorization
- Support with Preparation of Documents in Response to RFIs
- Document Checklist for Submission Tracking
- Authoring and Review of WHO ICTRP Data Elements
- Translation Support
- Educating Teams on EU CTR 536/2014 Requirements Submission Requirements
