Clinical Data Management

Scope International's many years of experience ensure that the data collection forms (CRFs) are designed to capture the data accurately and that a validated database that complements the CRF is set up. A data management plan (DMP) is set up for each project to describe the consistency checks that are run and Scope International's trained data managers issue clear and concise data queries. They also identify protocol violations and ensure efficient database locks. A rigorous QC process with error analysis is also performed on all entered data.

Scope International has a team of programmers to design the database (Clintrial®) and program the data listings and consistency checks in SAS®. The data capture system includes double data entry from paper based CRFs into an FDA compliant database system using Clintrail®.

Our trained coding specialists code the clinical data using standard coding dictionaries including MedDRA for the adverse effects and medical history and WHO-ART for the concomitant medications.

All the data management processes are tracked electronically allowing regular updates on patient status, data receipt including missing segments or pages, data entry and verification, data query status and protocol deviations. The phases of data management processes are logged as:

CRF design, review and production
Preparation of data handling manuals
Database design, implementation and administration and validation (Clintrial®)
Double data entry
Data validation and data monitoring (query generation and tracking)
Data coding using standard thesauri (e.g. ICD-10, WHO-ART, MedDRA) and custom dictionaries
Data transfer (import and export)
Data listings
Quality control
Archiving

Clintrial® Clinical Data Management System

With great success, Scope International database developers have embraced Clintrial, the market leading Clinical Data Management System (CDMS). Clintrial is a robust, flexible, and powerful option for our clients who wish to use a CDMS that excels in double data entry.