Services

CLINICAL DATA MANAGEMENT

Clinical data for regulatory submissions requires accuracy, audit trail, legibility, completeness, time stamps and attribution to the authorized source. MedKuest works with partners to tailor the needs for the following

Data Acquisition
Data Reconciliation
Discrepancy Management
Database Lock
Data Extraction for Reporting

Subject matter experts in data science, medicine and regulatory compliance, help draw meaningful information that can be presented to meet the study goals.

"In God we trust; all others must bring data." quoted from The elements of statistical learning

MedKuest can support the development of strategy for data management and documentation including CRFs, CCGs, edit check specifications, SAE reconciliation plans, Data Management Plans (DMP), Data Validation Plan

Provide service for study team review with cross functional team (s) for development of CRFs for potential data collection and creating database structure that allows identification of data entry problems to ensure all captured data follows the rules outlined by the protocol and data management plan

Periodically complete risk based monitoring, data validation and ensure that discrepancies are addressed, documented and reconciled. Ensure all data management activities are being executed and tracked as per the agreed plan. Ensure filing and documentation of clinical data management documents (eTMF) and keep it accurate and current. Support GCP inspection readiness. Participate in study team meetings. Participate in departmental SOP development and process initiatives.