elderbrook solutions supports a broad spectrum of data related activities in clinical research. With elderbrook you´ll find a partner experienced in the fields of supporting: data management activities, development of clinical databases, statistical programming
and trial management.
Data Management is key in clinical research
Data Management Activities
Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. Team members of CDM are actively involved in all stages of clinical trial right from inception to completion. They should have adequate process knowledge that 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.
Development of Clinical Databases
Clinical databases are valuable tools in planning clinical research. Skilled resources are required to develop and maintain clinical databases. In an era when much research funding is directed at hypothesis-driven research, the importance of these clinical databases in developing clinical research hypotheses should not be overlooked.
Statistical Programming - the heart of clinical reports
Statistical Programming - based on SAS standards
SAS is a leader in business analytics. Through innovative analytics it caters to business intelligence and data management software and services. SAS transforms data into insight which can give a fresh perspective on business. SAS takes an extensive programming approach to data transformation and analysis rather than a pure drag drop and connect approach. That makes it stand out from the crowd as it gives much finer control over data. SAS has a very large number of components customized for specific industries and data analysis tasks.
elderbrook provides programmings skills:
- Junior Programmer
- Senior Programmer
- Principal Programmer
- Expert Programmer
- Principal Statistician
- Expert Statistician
Support for Trial Management
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.
elderbrook supports you with:
elderbrook supports you with:
- Clinical protocol development
- Regulatory processes
- Clinical site selection, training and management
- Clinical monitoring
- Safety Monitoring
- Data management
- Statistical analysis of clinical data
- Human subject protection and ethics