Data Management

With more than 5 years of experience, Ramus Medical provides advice and assistance to clients for selecting the most appropriate technology to collect data depending on study size, number of study sites and therapeutic area.
Data Management services include:

Drafting of the Data Management Plan

Coding of medical terms using international dictionaries (MedDRA and WHO-DDE)

Defining variables to be implemented in the database and validation the study database

Defining Data entry mode (single / double) for paper based studies

Defining the Data Validation Documents with relative edit checks to be implemented on data

Design and development of the CRF

Evaluation of data entry inconsistency, generation and management of queries

Producing specific listed study documentation requested by the Sponsor (a support to Medical monitoring and Risk-based monitoring)

SAE Reconciliation

Database closure and data release in several formats such as SAS for Statistical Analysis

The data management team is in close contact with the IT team to ensure computer system validation.
The data management team collaborates closely with expert SAS programmers and makes sure that all data complies with specific company structured standards and CDISC standards.
The collected data is stored in our server for the entire period of the study and is backed-up daily. In accordance with Sponsor specifications, both paper and electronic documentation can be easily accessed for subsequent analysis after the conclusion of a study. All our procedures act in accordance with local privacy regulations.