When clinical trial study stakeholders are able to complete and sign important documents electronically, significant time and money savings can be realized. SureWorkflow provides cloud-based, automated clinical trial document acquisition, signing and completion with FDA 21 CFR Part 11 and EC Annex 11 compliance.
By ensuring that your documents follow a preset process of completion, routing and approval you can streamline manual paper handling clinical trial processes and enhance regulatory document quality. Investigators and study team members complete, sign and upload digital document information such as FDA regulatory forms, trip reports, and other study content. Document Signing is supported with digital certificates that meet FDA and EU Annex 11 requirements.
- Save time and complete trials in less time through automation of manual tasks
- Lower clinical trial costs
- Enhance clinical trial document quality and integrity through automated enforcement of SOPs and processes
- Automate manual work tasks such as form acquisition, document indexing, document uploading and archiving to eTMF repositories
- Integrated electronic document signing that conforms to FDA CFR 21 Part 11
- Use existing Adobe® Acrobat® Forms to design forms and add them to an electronic document workflow
- Support for Business Process Modeling Notation (BPMN) concepts of Processes and Tasks to model workflows