Clinical Biostatistics from Clinical Development Plan to answering regulatory questions during/after the filing.

At clinCORE we provide a host of statistical services that start well before the finalization of a study protocol. We understand that a study is only a step on the scientific and regulatory path. Following are the major services we provide:

Consulting

We leverage our extensive statistical theoretical knowledge, practical know-how, and significant experience in communicating with regulatory agencies worldwide to help optimize clinical programs by choosing the best study designs, endpoints and analytical strategiew. Our consulting encompasses development plans, study protocols and filing strategies. We have significant experience in implementing novel/adaptive study designs when modification of study parameters need to be considered based on interim data, and can represent sponsors at regulatory meetings.

Statistical Analysis Plan

The statistical reporting process at clinCORE begins when we start developing the Statistical Analysis Plan (SAP), detailing all planned analyses and including mock tables, listings, and figures (TLFs). The Biostatistician will then develop a set of programming specifications for the analysis datasets and all TLF outputs. Each TLF will be custom programmed with output that is consistent with the SAP and with clinCORE Research standard output specifications.

CDISC Compliant Datasets

The SDTM standard is going to be mandatory for all FDA submissions (from 2017). This data standard does not exist in isolation, nor is it an unchanging set of rules. Rather, SDTM is part of a holistic, interlocking set of standards, which includes, for example, analysis data model (ADaM), CDASH, ODM, and define.xml. These sections are continuously under development. Nearly every CRO offers SDTM services for new study mapping and for conversion of legacy studies. clinCORE stands out from the crowd in our approach to implementing the CDISC standards in general, and the SDTM standard in particular.

Statistical Outputs

clinCORE practices 100 percent independent programming for the validation of all analysis datasets and TLFs. Two or more Statistical Programmers will follow the programming specifications independently to produce the datasets or TLFs for this project. The programmers will then compare the two outputs for consistency. After the programmers complete their validation, the Biostatistician will review all outputs to confirm they are consistent with the statistical programming methodologies and algorithms described in the SAP. After the Biostatistician has reviewed and approved the outputs, a Senior Biostatistician will perform a high-level statistical review as an additional quality control (QC) measure ensuring interpretability of the results.

Data Monitoring Committee

We support DMCs by helping draft the charter, choosing the voting members, and by providing statistical support for DMC’s decision making process.
Integrated Documents/Filing – We prepare the components for a regulatory filing starting with the story boarding. We prepare integrated pharmacokinetic, safety and efficacy documents, and other components for the electronic filing of the approval package to the FDA. We also, help prepare periodic safety reports such as DSURs and PBRERs.

Regulatory Questions

clinCORE can answer all questions that arise from the filing in a timely fashion. Most often, these questions are related to statistical methodology and/or data/analytical issues.