Quality Commitments
NovoBliss Research comprehends that the key to any successful clinical trial is having reliable and accurate data entered in a timely fashion. We set high expectations for ourselves in regard to the data that we provide to the Sponsors, and the care that we provide to our study participants.
NovoBliss Research has a number of SOP’s, Training Manuals, and Training Programs, policies, working instructions, templates and forms to assist in the quality of our data collection. Our QA performs study audits on a regular basis. The following is an abbreviated list of duties our Quality Assurance Department performs in order to ensure you receive data of the utmost quality:
- Review study protocols, EDC screen shots, and source documents to ensure that the source accurately and completely reflects the protocol’s requirements and site’s documentation requirements
- Review completed source documents for accuracy, completeness, and legibility
- Compare data in source documents to data transcribed in EDC for accuracy
- Identify trends in errors to initiate improvements in source document flow, collection and site processes
- Review trial master files, regulatory binders for proper organization, filing, delegation of authority, documentation and completeness of training
- Review site processes and forms and suggest revisions that will make the collection of data more streamlined
Adherence to the above processes, in combination with relevant guidelines for clinical research and good clinical practices is what leads NovoBliss to constantly evolve, improve, and efficiently provide your company with quality data.