Our experienced Biometrics group, based in Denmark and UK, offer the full range of Statistical Design & Analysis, CDISC, Data Management and other related services needed to progress a product through the drug development process.
We focus on accuracy and clarity, ensuring our customers return time and time again.
We can provide a wide range of statistical input for study design, protocols, clinical development plans, sample sizing, randomisation and statistical analysis plans. We can also provide statistical oversight for those clients that need an experienced statistician to support their drug programmes and/or perform Sponsor oversight of outsourced statistical services.
Study Reporting and Post-hoc Analysis
We perform SAP writing, full Table, Figure and Listing (TFL) production, interim analyses and statistical report writing. We also provide post-hoc and/or exploratory clinical trial analysis and advice.
Other Statistical Support
We can support your statistical needs in many other ways, such as statistical oversight support, independent quality control of statistical activities, statistical due diligence (e.g. in-licencing of drugs), journal manuscript input and review, and advice on processes and audits.
We were founded on our SAS and CDISC expertise and we can provide comprehensive and effective SAS CDISC programming support for CDISC conversion of legacy and ongoing studies. S-cubed’s programmers and statisticians have converted over 200 studies to CDISC standards.
CDISC Compliance Checking
Having worked with CDISC standards since 2004, we are very familiar with what CDISC issues can typically arise. Based on our extensive experience in performing CDISC conversations and programming, we provide a CDISC checking and compliance service. For example, clients that have received a set of CDISC (SDTM or ADaM) datasets and CDISC deliverables (e.g. Define.xml, Reviewer’s Guides or SDTM annotated CRF) can have these items checked to ensure they conform to all the required regulatory CDISC standards.
Database Design and Set-up
Our Data Management staff have extensive experience using a variety of database systems and can work with a client’s preferred database system or we can suggest and provide S-cubed’s database solution.
Data Management Support
S-cubed performs the full suite of Data Management and database set-up services from planning and documentation (Data Management Plan and Data Validation Plan), CRF (EDC or paper) design and testing, diary card (or ePRO) and database design, data entry, discrepancy management, medical coding, SAE reconciliation and database lock activities.
Through our close working relationship with a preferred partner, we offer both clinical monitoring and clinical project management services.
We can perform your medical writing, such as writing ICH-compliant clinical study reports.
We can combine and integrate data from your studies into a single integrated database, whether it be for safety data evaluation and reporting purposes or the full complement of study data types.
Regulatory Electronic Submission Preparation
Using our large team of CDISC SAS programmers and statisticians, we can perform CDISC conversion of legacy studies, and produce your ISS, ISE and associated CDISC integrated datasets (including BIMO listings) and CDISC deliverables (e.g. Define.xml, reviewers guides and SDTM annotated CRFs) for your electronic submissions. Our CDISC datasets and deliverables are all to current FDA standards.
Regulatory Agency Meetings
We can accompany you as the responsible statistician, as well as perform analyses, review/prepare agency questions and supporting material and perform presentations, at regulatory authority agency meetings.
We support all aspects of DSMBs, whether it be participation as an independent statistician and/or preparation of charters and analyses.
CDISC FDA Submission Support
S-cubed’s programmers and statisticians have supported more than 20 successful FDA submissions. We can produce the ISS, ISE and their associated integrated CDISC databases, together with all submission CDISC deliverables (such as Define.xml and Reviewer’s Guides).
CDISC Training and Advice
We are CDISC authorised trainers in SDTM and ADaM. We advise pharmaceutical companies all the way from first steps of implementing CDISC through to full implementation. We are registered solution providers for the following CDISC standards: Analysis Data Model (ADaM), Clinical Data Acquisition Standards Harmonization (CDASH), Controlled Terminology, Define-XML, Standard for Exchange of Nonclinical Data (SEND) and Study Data Tabulation Model (SDTM).
Data Management Consultancy
S-cubed can perform all data management services for a client or act on a consultancy basis for particular aspects. We can also provide data management oversight for clients that don’t have their own data management function. We can also manage and review third-party data.
S-cubed’s main clinical database solution is OpenClinica and we have successfully databased and reported many studies using this system. OpenClinica is used internationally by a wide variety of pharmaceutical, biotech and device companies. It is a user-friendly, comprehensive, fully validated 21 CFR Part 11 compliant system which can be accessed via a range of EDC and ePRO devices. For further information see: www.openclinica.com.
IB and DSUR Support
We are very experienced at supporting our clients in the production of safety data presentations required for an Investigator Brochure (IB) or Development Safety Update Report (DSUR). We can also write these reports if required.
If you don’t have the facilities to host and store the data for all your studies for a drug programme then we can do that for you, on our servers in our secure, highly-controlled environment. Then if at any point you require us to examine or report that data then we can do so.
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