Scope of Services
Protocol & SAP Development
Development of clinical trial protocol, power sample size calculation, randomization scheduling and study design. Statistical review of DMP and eCRFs to ensure data to be collected will meet the statistical analysis and reporting requirements per protocol. Develop Statistical Analysis Plan (SAP) and TFL shells according to the clinical study protocol.
Phase I-IV Studies, PK/PD Studies
R Square Teams have been supporting many Phases I, II, III and IV Studies including PK/PD studies. For each study, our services include, but not limited to: Protocol and SAP Development; Clinical Data Management; Clinical Data Analyses and Tabulation; Nonmem and PK/PD analysis; Clinical Study Reports and Data Validation, and FDA submission support.
Interim & DMC Analysis
A firewall for a restricted Interim and DMC study folder will be set up in R Square network. Based on the DMC charter, Protocol and CSR SAP, and specification from clients, our independent statistician prepares the statistical analysis plan including mock up tables, listings and figures (TLGs). Develop two sets of TFLs: One set combines (pools) all treatments together as a total for sponsor review and used in the open session of the DMC meeting. The other set of TFLs is unblinded to treatment group but masked to identity of treatment groups and is used in the closed session of the DMC meeting. This procedure ensures the blindness of the study treatment codes to sponsors and other unrelated personnel.
CDISC
Our CDISC service consists of the following: aCRF annotation, SDTM domain and ADaM dataset specifications, SDTM mapping, ADaM data set generation, Independent validation of SDTM and ADaM datasets, Pinnacle 21 validation, Creating Define.xml, Creating Reviewers Guides, Convert SDTM and ADaM datasets to transport file.
Statistical Analysis & Programming
Our teams use SAS and R to develop analysis and reporting tools to support clinical studies and post FDA approval services. Our statistical analysis and programming service include mainly: Create datasets and TFLs for CSR, ad-hoc requests and publication supports; Independently validate datasets and TFLs; Database quality assessment, data reconciliation and consistence checking; Dry runs and final deliverable of datasets and TFLs in FDA submission format to support New Drug Application.
FDA Submission Support
FDA submission including NDA, BLA, ISS/ISE; CDISC (SDTM and ADaM), eCRT submission package, DDT, IB, and IND.
BIMO
Our BIMO team prepares the following package per the current FDA regulatory requirements: Clinical Study-Level Information: A Comprehensive and Readily Located Table Listing All Clinical Sites That Participated in Clinical Studies. Table Listing All Entities to Whom the Sponsor Has Contracted Clinical Study-Related Activities; Subject-Level Data Line Listings by Clinical Site (Previously known as OSI listings (FDA Office of Scientific Investigations); Summary-Level Clinical Site Dataset; Clinsite.xpt: One record per efficacy endpoint per site per treatment arm per principal investigator; Define.xml; BIMO Data Reviewer's Guide.
Other Services
R Square provides a wide range of services for our sponsors in the pharmaceutical and biotechnology industries. In addition to the above scope of service, we also offer services in IT, clinical project management, scientific research, health economics and outcome research (HEOR), real world evidence (RWE), medical and scientific communication, regulatory and medical affairs, and professional services supporting the life cycle of clinical trials.