MDS Pharma Services - Early Clinical Research : Seamless Data Integration

Streamlined Data Flow Process
MDS Pharma Services’ streamlined data flow process maintains consistency with industry leading CDISC standards from data collection through to data submission.

Data Capture
Our proprietary in-house optimized data capture system ClinQuick® provides consistency of clinical operations and data collection across our sites, ensuring accurate, high-quality data which reduces time to database lock. The recent Urine Module upgrade increases data quality and integrity by providing automated sample identification, sample traceability and rapid access to results.

Data Output
Through our consultancy services, MDS Pharma Services will utilize our in-house CDASH compliant data acquisition SAS database format and associated electronic PDF format CRFs to set expectations up front, fully scope the project and standardize accepted data formats resulting in time savings on the back end. The submission database content/structure is usable throughout the drug development lifecycle of your compound eliminating rework.

Data Migration
MDS Pharma Services expedites your clinical study data from CDASH to CDISC while maintaining compliance with FDA and other regulatory agencies. Our expansive offering includes biostatistics – detailed Statistical Analysis Plans, and tables, figures and listings in addition to PK/PD analysis and interpretation.

Data Submission
MDS Pharma Services is one of the leading CROs for complete data reporting, thereby saving sponsors’ time and money on their drug’s overall development timeline. The structure of the ICH E3 Clinical Study Report is compliant with the eCTD and is delivered as a fully electronic PDF format standard deliverable (vs. paper) to assist clients in their submission process. The addition of SAS Drug Development® to our services portfolio enables MDS Pharma Services to deliver submission ready data in an eCTD compliant format while expediting delivery of item 11 and 12.

Data Cycle