Clinical Trial Global Registry Submission Support
At Quanticate, we are committed to providing trusted and comprehensive solutions to meet the periodic transparency requirements of global registries related to clinical trials.
Our expertise, experience, and dedication to transparency laws, regulations, and industry standards make us your ideal partner in ensuring ethical, compliant, and responsible data sharing while safeguarding patient privacy and sponsor proprietary information.
Our Transparency Services:
Protocol Registration
Our expert writers manage timely protocol registration on applicable registries.
Protocol registration form (PRF) Maintenance
We offer comprehensive and timely support in PRF maintenance of clinical studies on ClinicalTrials.gov.
Study Results Postings
We excel in results postings on registries like clinicaltrials.gov, EU Clinical Trial register/EU CTR, CTIS etc., per primary completion or final study completion milestones.
Redacted Documents
We redact all documents, including but not limited to Statistical Analysis Plan (SAP) and Clinical Study Protocol (CSP).
Data Privacy
We prioritise the protection of patient data and maintain the highest standards of data privacy and security.
EU CTR 536/2014 Support
We offer comprehensive support in compliance with the European Union Clinical Trials Regulation (EU CTR) 536/2014 for trail registration and results postings.
EMA Policy 0070 and Health Canada PRCI compliant submissions
We ensure adherence to the anonymisation and redaction guidelines of European Medicines Agency (EMA) and Health Canada’s Public Release of Clinical Information (PRCI).
Compliance and Sanctioning Principles
We support you with compliance to regulatory requirements and avoid penalties associated with non-compliance from respective regulators.
Ethical Obligations
We help you to enhance patient engagement, improve your reputation with patients and public perception by making your clinical trial results public.
Additional Details of Our Transparency & Disclosure Services
Lay Summaries
Increase public interest and trust in your clinical research with clear and concise PLS of your clinical studies.
Clinical Trial Registration and Result Disclosures
Comply to clinical trial disclosures requirements and receive registration support on all major global clinical trial registries.
Data and Document Anonymisation
Ensure anonymisation compliance and protect patient privacy and company data
