Clinical Data Management

We are committed to supporting your company from the design of the clinical trial to study close, and ensuring the highest level of data quality. We offer robust systems that meet regulatory guidelines (FDA, EMA) and conventions, including 21 CFR Part 11 and ICH-GCP. Let the knowledgeable experts at Sainalytics guide your company through the entire data management lifecycle.

Our data managers work to ensure on-time results of your clinical trial data. Sainalytics delivers your data before critical deadlines. While we offer quick turn-around times, we never sacrifice the quality of our results.

From clinical development planning to data delivery, Sainalytics is committed to customizing data management solutions that emphasize accuracy, integrity, accountability and transparency as much as agile reporting. We take pride in producing results that are reproducible, source-verified, delivered on time and cost-efficient.

Our services include:

  • (e)CRF design and preparation of annotated CRF
  • Database design
  • Clinical data entry
  • Laboratory data handling
  • Medical/Dictionary coding
  • Data validation and query management
  • Knowledge and use of current data standards (SDTM, CDASH, and other CDISC standards)
  • Quality control and data base lock
  • (Blinded) Data Review
  • SAE reconciliation
  • Setting up status reports and statistics
  • Preparation of statistical or integrated reports
  • Third party vendor management