This phase III, multicentre, randomized, repeat-dose, open-label, parallel-group study to assess the efficacy and safety of the investigational drug – eye drops – compared to the already registered medicinal product has been started 8 months ago when OCT medical writers have been involved in the project. Their objective was to develop the study design, work out Essential Study Documents and prepare a package for a submission to the Russian regulatory bodies.
6 months ago OCT has obtained the approval for this study conduct from the Ministry of Healthcare of the Russian Federation, giving the rise to the main part of the project – investigational sites initiation and start of patients enrollment.
156 subjects who have undergone uncomplicated unilateral cataract surgery have been recruited to this study by the investigators in 8 medical sites over Russia within 4,5 months, which responded to the plans and requirements of the study.
Now the patients keep receiving treatment. After the end of the treatment period patients will be followed up while OCT data managers will be working on clinical data cleaning and validation in order to ensure the consistency and accuracy of all the clinical data derived from the current study.
Clinical data is inherently the most valuable asset to the study’s Sponsor since it appears to be the basis for analysis of the drug’s value and decision making regarding the next following phases of research, as well as marketing of the investigational product. For this reason, OCT data managers’ task is to manage queries and perform edit checks so as to get rid of the possible mistakes or errors that may appear during data entry by the principal investigators and provide “clean” data to the Sponsor.
OCT in-house Data Management platform Data MATRIX is 21 CFR part 11 compliant and fully validated in accordance with the international standards. Data MATRIX supports both paper CRF and electronic CRF-based clinical trials, and is very popular among our clients. For the current study, e-CRFs are used due to the number of medical sites involved in the study.
After the data is cleaned, the trial database needs to be locked so that no alternations could be made to it. This step is followed by the final statistical report preparation by OCT biostatistician and final integrated report writing by OCT medical writers.