Clinical Data Management

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The Clinical Data Management (CDM) Team currently manage data from Clinical studies within the guidelines established by our internal Standard Operating Procedures (SOPs). Systems and processes, and sponsor guidelines. The department has a proven track record of achieving milestones and high quality deliverables. The department has been through many successful audits from our sponsors and external consultants.

The department has many years of clinical data management experience and is fully trained according to the our standard human resource development program. Covering data management practices, programming, computerized system validation, ICH/FDA guidelines.

Our data management system is validated as per 21 CFR Part 11 compliance. The system is a combination of modules that use an Oracle database and integrates with other applications in order to setup screens, perform data entry and run data validation tools.

CDM Team comprises of

  • The Director
  • Project Data Managers
  • Clinical Data Analysts
  • Data Base Programmers
  • Medical Coders
  • Process Executives
  • Administrative Assistants

Global Data Systems and CDM Team Goal is

  • To deliver results according to sponsors' expectations in terms of timelines, data quality and communication.
  • To be compliant with ICH/GCP, FDA and other standards guidelines and practices.
  • To ensure thorough documentation around the data management processes and the use of data systems.
  • To hire and train highly competent individuals.
  • To maintain, develop and upgrade systems which allows for fast, reliable data capture and data validation.
  • To advance processes for delivery of high quality data reports.
  • To communicate effectively and accurately with sponsors.

 

CDM Activities are:

Case Report Forms (CRFs) Design

The protocols are transcribed into detailed CRF pages that ensure proper data recording and accurate entry into the clinical database.

Data Management Plan

The Data Manager writes the data management plan which describes all procedures to be followed and summarizes responsibilities.

Clinical Database and Data Entry

By using standard tools and processes, a flexible and validated database system enables the department to meet sponsor requirements. Once the database and the data entry screens are setup, double data entry is performed.

Clinical Data Validation

Data validation are developed based on the data management / data validation plan and data specifications. They include several types of listings as well as queries. They cover, and are not limited to, the verification of out of range values and inconsistencies between data and protocol compliance checks.

Coding

All Adverse Events, medications and other data as required are coded according to standard dictionaries (e.g. MedDRA), internal global code lists and sponsor requirements.

Data Transfers

Data is provided to sponsors in a mutually agreed format (e.g. SAS transport files) and when required (after testing).

Filing and Archiving

CRFs and data validation tools are filed in a secured, access-controlled archive room. Daily data back-up is performed and archived according to standard IT procedures.

Data Management Reports

The Data Management Reports summarize for the sponsor and project management major events related to data management processes and decisions. The sponsor receives regular updates and is intimately involved in data management-related decisions. Standard and study-specific documents are generated to provide an accurate description activities and performance.

Biostatistics

Our in-house biostatisticians will provide crucial analytical expertise for coordinating clinical trials. Our statisticians are involved in trials from design to total analysis. Our biostatistical services includes

  • Determining sample size and statistical power
  • Developing statistical analysis plan
  • Analyze trial database
  • Performing both simple and complex analysis on SAS®
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