MCRA's goal is to provide the unparalleled data management and statistical support & strategy for our clients, and is achieved with the help of its exceptional data management and biostatistics team.
MCRA understands that the results of any clinical study are only as good as the data that supports those results and is committed to providing excellent data management services that have been tailored to each of our clients. To ensure realization of this commitment. MCRA's data management department has partnered with several cloud-based clinical data management solutions which allows us to use a wide array of systems and tools to ensure that each study is matched with the best set of tools based on the needs of that individual study.
The data management team prides themselves in providing highly personalized services with each solution being developed with the unique needs of the study in mind. Our extremely personable team is always available to our clients and study sites to ensure that the solutions being built are exactly what is needed for a given study and that all parties are comfortable in the use of these systems. Highlights of these systems include:
- Real-time access to the clinical data for clinical sites, sponsors and members of the CRO
- 24/7 server monitoring to ensure accessibility, security and performance
- API interfaces with other clinical trial management systems and data analysis programs
- Seamless integration between the data, biostatistics, clinical and regulatory teams
Data Management Services
- Full-service or independent data management support including hand-off of Electronic Data Capture (EDC) system builds
- Database rescue and rebuilding services
- Integrated ePRO consulting and support
- eCRF design, specifications and completion guidelines
- Mid-study database changes and eCRF revisions
- Automated importation of central laboratory data
- Medical coding of events, medications, procedures and therapies
- Database lock and archival into multiple formats
The biostatistics team's main services are centered on the review of the study design, development of the statistical analysis plan (SAP) and performing the programming and analysis in support of the primary and secondary objectives as outlined in the SAP, however they also play a key role in the calculation of sample sizes, power calculations as well as support for ongoing data quality assessments and FDA progress reports.
The final statistical analysis tables, listings and study report are generated per the interim analysis scheduled as outlined in the study protocol and at the end of the study. Adverse events, protocol deviations and clinical data will be compiled and analyzed from data directly pulled from the study database. As such, the biostatistics and data management teams work closely together to ensure smooth and secure transmission and analysis of study data. The analysis tables, listings contained within study report provide the basis for a marketing approval application and the development of peer-reviewed publications and as such are handled with great care by unsurpassed team of expert statisticians
- Determination of the optimal statistical strategy to meet each client's regulatory objectives
- Statistical support for pre-clinical, clinical and post-market studies
- Drafting of the SAP including comprehensive mock tables, figures & listings
- Negotiation and defense support regarding the proposed statistical design & analysis methods with the FDA and other regulatory agencies
- Preparation of statistical reports, scientific manuscripts & abstracts in accordance with the FDA's expectations for clinical reporting