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Preparing Data Packages for proinnovera GmbH

In March 2020, proinnovera GmbH, a dermatology-specialized European CRO, joined efforts with OCT Clinical’s team to carry out interim statistical analysis in its study on 7 subjects and prepare necessary data packages. The database lock was performed in September, and by October OCT had successfully completed all assigned tasks and delivered all required data packages. The primary goal of the study is to evaluate the safety and pharmacokinetic profile of the active ingredients and their metabolites after application of the studied medical product.

OCT Clinical’s biostatistics and statistical programming team was assigned to do the following: SDTM package (SDTM datasets programming and validation, annotated CRF, Study Data Reviewer’s Guide, define.xml), ADaM package (ADaM datasets programming and validation, Analysis Data Reviewer’s Guide, define.xml), Interim Statistical Analysis Plan, TFLs programming and validation, and Interim Statistical Analysis Report. Prior to the database lock a Data Review Meeting was organized to ensure the completeness and correctness of the data, as well as to review and assign ratings to protocol deviations and define analysis populations.

A draft interim statistical report was written by the OCT biostatistics and statistical programming team within 2 weeks of the meeting and database lock. All the minor comments were addressed effectively, which allowed for the statistical analysis report to be finalized within 3 weeks of the DBL. 

Datasets and metadata were prepared in CDISC compliant format. The process of preparation of SDTM and ADaM packages was carried out in parallel with TFLs programming, so they were also delivered shortly after the interim statistical report. As per standard OCT practice, all analysis datasets and the majority of TFLs were QCed by double programming. SDRG/ADRG and define.xml also underwent rigorous review by a senior statistical programmer and a biostatistician.

Despite extremely tight deadlines and an extensive number of required deliverables, the OCT team was able to manage the workload and deadlines effectively and provide carefully designed data packages compliant with ICH guidelines, regulatory standards, and research objectives.

“One of the core principles at OCT Clinical is to focus on quality culture and regulatory compliance. To support this principle, we have been performing in-depth quality control and validation of statistical deliverables,” — commented Kristina Bondareva, Head of the Biostatistics Department at OCT Clinical.

Preparing data packages for successful submission is a significant part of OCT’s services portfolio. OCT Clinical’s experts offer flexible biostatistics solutions driven by every particular clinical research goal. More details about clinical trials services provided by OCT can be found here

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