clinical data management (cdm) accompanies a critical phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical trials.
experienced and effective data management ensures data quality from the point of collection and contributes to a drastic reduction in the time from drug development to marketing.
team members of cdm are actively involved in all stages of clinical trials right from inception to completion. adequate process knowledge helps maintain the quality standards of cdm processes. various procedures in cdm including case report form (crf) designing, crf annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a trial.
clinical databases are valuable tools in planning clinical studies. skilled resources are required to develop and maintain clinical databases. in an era where much research funding is directed at hypothesis-driven research, the development of effective and standardized clinical databases to verify clinical research hypotheses is becoming increasingly important.
although sas® has a very large number of components that are especially tailored to data analysis tasks in clinical research, and sas® certainly continues to be the leader in business analytics, more and more statistical programming languages that can be used cost-effectively are establishing themselves alongside this standard software. in addition to our experienced sas® experts, elderbrook solutions has now also built up a large international network of skilled r® and python® statistical programmers. therefore, we are able to provide professional services especially for the following statistical programming tasks:
- preparation of statistical analysis plans (sap)
- creation of analysis datasets (ads) according to sponsor specifications and/or industry standards, i.e. cdisc
- validation of analysis datasets (ads)
- programming and validation of tables, figures and listings (tfl)
- macro validation in line with regulatory requirements and industry standards
beyond this we support our clients with biostatistical services performed by an international team of industry-experienced biostatisticians. Profound knowledge of statistical procedures and methods in the evaluation of clinical trials, combined with expertise in different therapeutic areas and a solid understanding of regulatory requirements (e.g. ich gcp, cdisc standards), enables us to achieve the highest quality of statistical results.