Service at a glance
| Item | Details |
|---|---|
| Provider | Hopkins MedTech Compliance |
| For | Clinical study sponsors |
| Work | Data management plans, CRFs, data review and database-lock preparation |
| Rules and standards | Study protocol and applicable data standards |
Data management in clinical trials is a necessary step to ensure accurate and reliable data are obtained.
HMC's team of experts are always qualified to provide the following services:
● Participate in designs of Research Protocols to ensure that data is appropriately Collected and managed
● Develop Data Management Plans
● Develop CFR and electronic data capture (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.
● Develop a Data Transfer Plan
● Data entry and case report form (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
Service information adapted from the original source ↗.
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