C ase st ud y RHEUMATOLOGY CASE A randomized, single-blind clinical study in two parallel groups to compare the pharmacokinetics, safety and tolerability of the study drug product vs. known drug product formulation. Therapeutic area: rheumatology, rheumatoid arthritis. The study was conducted under very tight deadlines for collection, processing and submission of data. Data MATRIX successfully completed this task and now continues to provide its support for the drug development program. Randomization strategy: no randomization numbers, involvement of an unblinded employee 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 gro

Join for free to read