Study Reporting & Analysis Services
The common thread across the Veramed team is a genuine focus on quality first
We understand that different clients require different levels of support, and this enables us to recommend solutions that are tailored to your needs – from outsourced reporting and delivery of large submission studies, to providing insourced consultancy services, for example for SDTM conversion or CDISC implementation.
Our programming team has vast experience in SAS and R, and is well-versed in providing high quality support across the board. We have experience in numerous reporting environments, client systems (and of course our own in-house solution) and all our programmers are trained on the Veramed Excellence Programme to ensure that technical aptitude is balanced effectively with consultancy and customer focus skills.
Quality Control process
- Specifications review
- Self QC
- Independent QC
- Double programming / code review
- Output review
- Consistency checks
- Sensibility checks
- Log checks
- Statistician review of all outputs
- Finalisation of QC log
- CDISC Review and Gap Analysis – Our most experienced programmers are skilled in performing a review of CDISC compliance and quality prior to submission.
- Programming 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).
- 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 programming and CDISC deliverables.
- Data Management Programming – From edit checks through to advanced visualisations, we routinely work with data management to help you identify complex data quality issues at the earliest possible point.
Analysis and reporting
- Specifications – Our programmers are trained in authoring and reviewing specifications for datasets, including Tables, Listings and Figures to ensure that programming 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 programming 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.
- DMCs / DSMBs – We provide and prepare the blinded and/or unblinded analyses for committee members with support from our statistical team. Our expert statisticians will ensure this process runs smoothly.
- Interim Analyses – 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.
Post reporting / Submission activities
- 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 fulfil transparency requirements, along with disclosure and research requests while safeguarding the privacy of individuals.
- Patient Profiles – We can provide basic profiles, visualisations, SAE and withdrawal narratives – depending on the requirements of your study.