Overview

The IMETICS data management group has the resources and experience to manage the data generated in your clinical trials.

We know that the proper handling of clinical data is essential to the success of your trials. IMETICS data management can provide a broad array of high-quality services to support the accurate collection, organization, validation and analysis of clinical data.

Data Management Services

- Data Management Plan

- CRF Design

- Administration and development of platforms for eCRF

- Database design and setup

- Database validation and auditing

- Double Data Entry and verification

- Planning, creation and validation of computerized edit checks

- Data Validation and Query management

- Data Correction

- Incorporation and cleaning of other electronic data (lab, ECG, etc.)

- Data Medical Coding

- Adverse Event/Medication Coding

- Serious Adverse Event Reconciliation

- Database Closure

- Data Management Report

- Creation of study-specific manuals for e-CRF training

- Metrics

- IVRS

- Real Time communication of Adverse Event by email or text message

Data Management and e-CRF creation tool

The Data Management Platform used by IMETICS is an eClinical solution, utilized in the Life Science industry for data management, analysis and clinical trial reporting.

This Data Management Platform is a complete web-based application built on a web technology for remote data capture and double data entry and manages all the steps in the process of bringing data from investigator sites to a clinical study database prepared for analysis.

Thanks to the solution’s web technology, data entry can be done by anyone who has access to the system and the web.

Our Data Management Platform a very powerful web-based tool that is flexible, dynamic, user-friendly and very easy to access from anywhere.

Regulatory compliance:

- Enables FDA 21 CFR part 11 compliance

- Administration of Users, Groups, User access and Study access

- Computer-generated Audit Trail

- Clinical database version handling

Advantages:

- Full electronic CRF management

- Native database structure

- Requires no client-side installation