Business areas and services
Data Transparency & Medical Writing
Ensuring compliance to regulatory frameworks.
Clinical Data Science
Biomarkers & Translational Data Science
Data Transparency & Medical Writing
Benefit from our proven experience in disclosure, transparency, and medical writing. We have successfully managed protocol registration and results posting for over 500 studies, ranging from standard phase I trials to complex pivotal trials.
You will benefit from our broad experience from the anonymisation of tens of thousands of pages and the review of close to 5,000 trial documents and counting. And our medical writers transform complex data into clear and submission-ready documents.
Clinical Trial Disclosure
Our experienced disclosure managers will guide you through the entire disclosure process, from protocol registration to the posting of results on public registries like ClinicalTrials.gov, CTIS and EMA’s catalogue of RWD studies.
We also support your Regulatory Affairs team in the preparation of EU clinical trial application part I data.
Protocol Review for Disclosure Readiness
Drafting protocols with disclosure in mind smooths the disclosure process and helps avoid potential compliance issues.
Our team of experts will support your trial team during protocol drafting, finishing with a protocol review from a disclosure perspective that will ensure all relevant requirements have been addressed.
Protocol Registration and Study Record Maintenance
Timely registration matters. Our disclosure managers are experienced in handling initial study registrations in compliance with applicable registry regulations and in line with our clients’ transparency policies.
Maintaining those study records demands juggling updated study dates and status, new sites, and protocol amendments. Let us simplify your agenda and do this time intensive job for you.
Results Posting
The posting of results presents evidence-based medical knowledge to the world and is the final important step in what is typically a long and substantial research program. Since this step is so critical, we at Staburo are determined to post your results successfully regardless of the complexity of the trial design.
Once your trial is completed, our experienced team will prepare and post the results, in full compliance with the requirements and quality review criteria of the respective registry.
Data Anonymisation & Document Redaction
After successful study completion, your team might receive internal and external data sharing requests and you will need to prepare a submission package to launch your product in the EU.
Redaction and Anonymisation of Study Documents
We provide expert redaction and anonymisation services to support compliance with global clinical data transparency requirements. Our team prepares disclosure-ready documents for regulatory frameworks including EMA Policy 0070, Health Canada PRCI/RPCI, and results disclosure on ClinicalTrials.gov, as well as supporting transparency needs for journal publications and other public disclosures.
Leveraging our in-house PPD ruleset and extensive transparency expertise, we work closely with clients to identify the most appropriate approach for the protection and redaction of commercially confidential information (CCI), while maintaining document quality, readability, and regulatory compliance.
Anonymisation of Individual Patient Data
For both internal and external data sharing initiatives, we offer anonymisation services for complete individual patient data (IPD) datasets.
We support the preparation of datasets for secure sharing within your organisation or for disclosure through external research platforms such as Vivli, ensuring patient privacy is protected while preserving the scientific utility of the data.
Data Sharing Evaluation
If you are not sure whether your data sharing agreement or signed informed consent forms (ICFs) permit the re-use of clinical data, our team can review the request alongside the relevant study documentation and guide you towards a compliant and appropriate resolution.
We support the assessment of consent language, contractual obligations, and applicable data privacy requirements to help facilitate responsible and efficient secondary use of clinical trial data.
Medical Writing Services
Our medical writing team delivers regulatory and scientific documents across the entire clinical development lifecycle, from study start-up to study close-out.
We work closely with in-house experts in Biostatistics and Data Transparency to transform complex data into clear, compliant, and submission-ready documents.
As a dedicated, partnership-focused team, we combine scientific expertise, cross-functional collaboration, and a commitment to quality to help advance your development program.
Expertise Across the Clinical Development Lifecycle
- Clinical study protocols and plain protocol synopses
- Patient informed consent forms
- Pharmacovigilance documents, including development and periodic safety update reports
- Clinical study reports, including patient narratives
- Plain language summaries of clinical trial results
- Publication support, including manuscripts, abstracts, posters, and conference presentations
You benefit from an experienced, interdisciplinary team of writers with extensive knowledge of EMA, FDA, ICH, and other global regulatory requirements, ensuring your documents remain aligned with evolving regulatory expectations.
Literature Reviews and Clinical Development Insights
Beyond document development, we analyse scientific literature, clinical trial registries, and publicly available study, regulatory, and HTA documents to generate evidence-based insights that support clinical development and regulatory decision-making.
- Estimand implementation (ICH E9(R1))
- Informed consent readability
- Endpoint selection trends
- Transparency and disclosure practices
- Protocol design trends
- Emerging clinical development and regulatory trends
Ready to Collaborate?
Whether you need senior biostatistics support, reliable data science expertise, or strategic guidance for your clinical development programs, our team is here to help.