Data Management

Data management in clinical trials is a necessary step to ensure accurate and reliable data are obtained.

HMC's team of experts areis always qualified to provide the following services:

● Participate in the design ofdesigns of Research Protocols, to ensure that data is appropriately Collected and managed

● Develop a Data Management Plans

● Develop CFR and EDC according to CDISC, SDTM, CDASH standards

● Performance of data validation activities, including: Project-specific Editing, Test Specifications, Data Validation Plan, automated test programming, input masking, and data review handmade.

● Developing a Data Transfer Plan

● Data entry and CRF tracking for paper CRF

● User training for EDC system and CRF completion rules

● Load data from external sources (central lab, ECG, etc.)

● Integrate the drug delivery and randomization (IWRS) module directly into the EDC . system

● Quality control of imported data

● Data cleaning operations for temporary and final database locking

● Prepare data management reports for quality control and metrics measurement

● Medical coding using MeDRA, WHODD and SAE collation