Our Services
Statistical Analysis of Clinical Trials
Standard statistical services for Phase I-IV clinical trials and ISS/ISE including authoring statistical methods section of the protocol, sample size determination, endpoint selection, development of SAPs, table, figure and listing layouts, randomization scheme design and code generation, and SAS programming to create tables, figures, and listings for inclusion in Clinical Study Report and interim analyses.
CDISC
Comprehensive CDISC services including conversion of clinical databases to fully-compliant SDTM and TDM domains, ADaM datasets, Define.xml, aCRF.pdf, and Reviewer’s Guides. All documents are created internally using proprietary tools developed in-house. CDISC datasets and metadata can be developed in real time while the study is ongoing and provided as part of the final deliverable following database lock; or it can be applied as a conversion of legacy data to obtain CDISC-compliant and submission-ready formatting.
Statistical Consulting
Statistical and strategic consulting including study design, exploratory sample size and power calculations, protocol input, endpoint selection, statistical methodology recommendations, assistance in correspondence with regulatory authorities, oversight of biostatistics and programming activities performed by a separate entity, CDISC conformance checks, and programming support that integrates into the sponsor’s environment.
Other Services
A vast array of other biostatistics and statistical programming related services, including:
Administrative and statistical reporting for Data Monitoring Committees including meeting coordination, charter development, TFL layouts for the DMC data review packet, statistical applications for stopping rules, programming of TFL outputs and creation of DMC data review packet, data packet presentation, facilitation of sponsor and DMC communication, and post-meeting document archival;
Exploratory and ad-hoc/post-hoc analyses for clinical development, medical affairs, data management, signal detection and safety surveillance, post-study data interpretation, scientific posters, and other presentations;
Programming applications for database reporting including customized patient profiles for data and medical review.