The right data management solution can make all the difference in a clinical study. We can take you through the entire process to help you understand the best options for your trial.

Symbios Clinical provides data management development services including both case report forms and database design as well as full support for data cleaning and query resolution.

Symbios Clinical provides a wide array of clinical databases and is “vendor neutral” when it comes to the selection process. This flexibility helps us to recommend the right database for each project. We support both paper-based and Electronic Data Capture (EDC) systems, and are our data managers are experienced with a variety of systems.

Our Data Management Development & Design Services include:

Case Report Form Design
Symbios Clinical develops the CRFs to ensure that they meet the needs of everyone involved in the data management process, starting with the statistician, and including regulatory, reimbursement, marketing, and others.

Automatic Edit Checks
Symbios Clinical develops a thorough set of automatic edit checks ensuring your data is consistently cleaned and reviewed. This reduces the overall time from when a form is received until it is fully cleaned.

Database Development
Symbios Clinical database developers are able to quickly create a database once the case report forms are designed. This minimizes the backlog of CRFs and data review needed. Our quality control process ensures that the database is completed in as few iterations as possible and that all of the case report forms and edit checks are built exactly to the specifications in the data management plan.

Symbios Clinical manages data based on a real-time data cleaning model. Other models waited to review data for accuracy and completeness until a monitor visited the site. This model timeline could take several months. This model also puts the burden on a monitor who might have a limited number of days on site or may need to extend their visit adding additional costs.

Our model has internal data managers review the data as soon as we receive it. In most cases data is reviewed within hours of being received. This technique ensures issues are addressed immediately and systematic issues are corrected before they become problematic. When a monitor then visits a site, their time will be spent more efficiently, focusing on their essential task - verifying the data in the medical records.

This model results in increased site personnel satisfaction because they receive immediate feedback regarding data completion errors. This increases patient safety by improving the quality of interim FDA reports, reports to DSMBs and Clinical Event Committees.