Data Management and Statistics

Professional Clinical Data Management can shorten your time to market


What is Clinical Data Management?

Clinical data management is the process of collecting, cleaning, and managing data in compliance with regulatory standards. The primary objective is to provide high-quality data and gather the maximum amount of valuable data for analysis. High-quality data should be attributable, legible, contemporaneous, original and accurate (ALCOA). The obtained data set needs to be suitable and statistically valid. The quality and type of data generated are important for the outcome of the study and can give you a head start on the competition. 



EDC Systems

Generally, electronic data capturing systems (EDCs) are used where investigators can directly upload the data in electronic case report forms (eCRFs). At the end of the clinical trial, the data set in the system is provided to statisticians for further analysis. An appropriate statistical analysis should reveal if differences in effects between two or more interventions are significant or due to chance. Data analysis must be tailored to your research questions and defined before data collection starts. The results of the data analysis are used in the clinical evaluation report (CER).

When Clinical Data Collection and Statistical considerations are not suitable, your study might fail. Make sure you do it right the first time. Important factors in Clinical Data Management:

  • Design of the database and the Case Report Form (CRF)
  • Data Management Plans: instructions, responsibilities, data sources and quality control
  • Data Validation based on Validation Checks
  • Data Analysis must be defined before the start of the study.


Qserve's clinical evaluation team has experienced Clinical Data managers and works with a professional, validated electronic data capture (EDC) system. Thereby we can ensure the reliability of your study data and construct a compliant database for final analysis. Our team can assist with all, or part of the Data Management Process, including statistical analysis and reporting.


What can we do for you?

Design: We can assist you with the design of a Data Management Plan.

Design: We can assist you with designing a Statistical Analysis Plan.


Design: Do you need help designing a Data Validation Plan? We can help you.