Best practice for Data MATRIX projects
Our team has been working with clinical data since 2009. Data MATRIX employees are proud to be members of many professional communities, which unite clinical data specialists (CDISC), data managers (ACDM, SCDM), biostatisticians (ISBC), and medical writers (EMWA, AMWA).
Association for Clinical Data Management (ACDM) and Society for Clinical Data Management (SCDM) are independent, non-profit organizations, which aim to extend professional standards of data management among the community. Their educational programs, industry meetings and conferences are dedicated to implement the best industry practices, which will become a basis for new modern approaches.
International Society for Clinical Biostatistics (ISBC) also researches the best methodologies, which can be used for design development and clinical trial analysis. The interplay between statistical theory and the real world of clinical medicine is often controversial. However, statistics are exactly what makes the approach to planning a trial and data interpretation scientifically grounded.
European Medical Writers Association (EMWA) and American Medical Writers Association (AMWA) give a space for active discussions and develop approaches to medical writing in accordance with current requirements of clinical trials. One of the recent important recommendations from these associations is CORE Reference. This project is aimed to help specialists in development of clinical trial reports, based on international guidelines ICH E3 ‘Structure and Content of Clinical Study Reports’. CORE Reference aggregates these requirements, European legislative provisions regarding open data, and important recommendations of EMWA and AMWA professionals in terms of different parts of report.
For Data MATRIX, being a member of all these organizations is not a formality. The methodologies of such professional communities’ make planning, conducting a trial and analyzing data relevant to requirements of all the Ministry of Health, FDA and EMA. They give a basis for qualitative work, which makes conducting an efficient study possible.