• CDISC Review and Gap Analysis – our most experienced programmers are skilled in performing a review of CDISC compliance and quality prior to submission.
• Programing support – we can provide Veramed programmers on a full-time, part-time or adhoc basis to work as part of your internal team (e.g. as contract/consultant programmers).

Check out our wide range of statistical consultancy service offerings on our consultancy page.

• Protocol review/input – statistical support in the development of the clinical trial protocol (and amendments) with consideration to the recent ICH E9 addendum around estimands.
• Randomization development – producing randomization lists and advising on the most appropriate randomization method for a particular study.

• Vendor oversight – we offer third party vendor oversight to ensure the highest quality for your trial – including planning for success, management of timelines and review of programing and CDISC deliverables.
• Data Management Programing – from edit checks through to advanced visualizations, we routinely work with data management to help you identify complex data quality issues at the earliest possible point.
• DMCs / DSMBs – we provide and prepare the blinded and/or unblinded analyzes for committee members with support from our statistical team. Our expert statisticians will ensure this process runs smoothly.
• Interim Analyzes – we offer expert advice on the design, management and implementation of interim looks at the data, whether blinded or unblinded, and we can guide you through this complex process.
• Data Review Meetings
• Protocol Deviation determination and review

• Specifications – our programmers are trained in authoring and reviewing specifications for datasets, including Tables, Listings and Figures to ensure that programing is efficient and focuses on quality from the outset.
• Study Analysis and Reporting – we can program analysis datasets of all levels of complexity and report high-quality Tables, Listings and Figures. As a result, we routinely achieve zero client review comments.
• CDISC SDTM Conversion – our programing team is trained to provide accurate and compliant CDISC SDTM datasets converted from a variety of different data sources.
• CDISC ADaM Implementation – we are trained to specify and provide accurate and compliant CDISC ADaM datasets. We are proud of our 100% record to date for submission quality.
• Statistical Analysis Plans – developing and/or reviewing clear and detailed SAPs and supporting mock output shells, in accordance with ICH E9, for clinical study reports, interims and DMCs.
• Patient Profiles – We can provide basic profiles, visualizations, SAE and withdrawal narratives – depending on the requirements of your study.

• CDISC Documentation – We develop Reviewer’s Guides (SDRG, ADRG), Define-XML, analysis results metadata and annotated CRFs.
• Data Anonymisation – We deliver support macro development and implement de-identification and anonymisation techniques to fulfill transparency requirements, along with disclosure and research requests while safeguarding the privacy of individuals.
• Patient Profiles – We can provide basic profiles, visualizations, SAE and withdrawal narratives – depending on the requirements of your study.
• Supporting ISS/ISEs
• CSR input/review
• Publications – we provide support throughout the publication process, from the concept, identification and implementation of appropriate analyzes, right through to the interpretation of the results.
• Strategic and collaborative support to help maximize remedy launch impact and ensure commercial success for your remedy.
  • Learn more on our Evidence and Value Generation page.