In an industry where data is king, getting the right start is paramount
By Kathryn E. Vinson, MS, CCRC
Clinical research has many sides. However, the truth of the matter is that it all boils down to the data. We can be the most compassionate research professionals, have superlatively compliant volunteers, and test the most promising therapeutics, but if the data isn’t sound and usable – it’s all for nothing.
That’s why partnering with the right CRO is vital. Not only does DZS Clinical Services have a vast array of clinical research experts, but we are also uniquely prepared to assist your team in ensuring you are submitting fully CDISC compliant data.
Even for those of us that don’t know it – CDISC standards are all around us. CDISC is the Clinical Data Interchange Standards Consortium – the group that develops the data standards used by the pharmaceutical industry. In fact, the SDTM (study data tabulation model) format is one of the required standards utilized for submission to both the FDA and the PMDA. From demographic information to AE assessments to causality determinations on AEs, CDISC standards and definitions are ubiquitous in clinical research.
With these standards being required by the FDA, studies must be developed to ensure adherence to these guidelines is considered from the very beginning. Case report form design is essential to smooth the pathway to compliance with SDTM standards as data is recorded from the patient records into the study databases.
As you can see, DZS Clinical Services has your trial covered from start to finish for full data compliance as a Gold level member of CDISC.
But what about COVID-19?
As everything seems to come back to COVID-19 nowadays, we have to be ready to address COVID related challenges such as infections and unavoidable trial delays. Fortunately, CDISC has published its interim user guide for COVID-19. We here at DZS have taken considered this guidance and are prepared to assist your team with any COVID related data issues, as well as preparation for vaccine and treatment trials for this pandemic.