Case study: rheumatology

Case study: rheumatology

Given

No randomization numbers; involvement of an unblinded employee; special study questionnaires; individual start dates and duration of the study.

Solution

Configuration of the MATRIX IWRS provided for completion of a number of mandatory forms in CRF prior to randomization which was carried out by an unblinded employee. CRF required specification of treatment group only without randomization number.

The MATRIX IWRS added an additional classification of users by their roles and blinding levels.

Patient questionnaire data collection forms were added to the MATRIX EDC. The duration of the startup phase was reduced from 2.5 to 1 month due to project-specific factors and upon the customer’s request. The data were exported to a biostatistician 2 weeks after the last patient’s last visit.

Two biostatisticians and one SAS programmer were involved in the project to prepare the statistical analysis plan of pharmacokinetic and drug safety data, and writing of relevant reports.

The study was conducted under very tight deadlines for collection, processing and submission of data. Data MATRIX provided timely and successful regulatory submission to the Ministry of Healthcare of Russia. Our team now is involved in the next phase of the clinical development program. 

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