Automate Your Work
SureClinical – Collaborative Cloud for Clinical Trials
SureClinical offers collaborative cloud application solutions that automate manual content management processes in health sciences. Built on an FDA Part 11 and HIPAA certified cloud platform with integrated high-trust digital signing, BioPharma companies can eliminate paper and accelerate the delivery of new therapies to market with significant cost and time savings.
SureETMF™ is a cloud-based, next generation regulatory content management application to manage electronic trial master files via a secure web portal. The solution enables clinical trial organizations and stakeholders to automate the capture, classification and digital signing of content online. Clinical trial stakeholders can collaboratively view, share, comment on and manage content from mobile, web or desktop. SureETMF maximizes productivity and enhances document quality for clinical trials by automating manual paper-handling processes. Labor and paper-intensive tasks such as document signing, classification, indexing, archiving and other labor intensive clinical trial content management processes can be automated through secure clinical trial portals. SureETMF ensures that study documents, medical images and eRecords for BioPharma clinical trials are always available to all stakeholders, either online or offline. Using industry standard technologies, SureETMF lets you create an interoperable eTMF model with published templates, or ‘content classification models.’ SureETMF lets you use any eTMF content model, or you can modify and edit provided content model templates to meet your needs. SureETMF is used by clinical trial Sponsors, Investigators, Clinical Research Associates and others who wish to install automated, secure, and cost-effective eRecord handling for global clinical trials.
SureArchive™ Cloud Service enables the secure, long-term retention of clinical trial documents, accessible online for instant viewing and sharing by your clinical study team, auditors or regulators. Typically clinical trial data must be accessible over the long term, with the terms being largely dependent on the governing regulatory agency. For example, the FDA requires investigators to retain clinical trial documentation for a period of two years post marketing approval, whereas the Canadian GCP stipulates that sponsors must keep trial documents for a period of twenty five years.
Given these regulations and the associated requirement to deliver archived documents to inspectors upon request within relatively short periods of time, sponsors are seeking ways to meet their archiving requirements through the application of cost-effective, cloud-based solutions. The SureArchive Cloud Service provides sponsors with an accessible yet indelible clinical trial document archive, offering sponsors assurance that their document management regulatory obligations are being met and ensuring the integrity of their records. Inspectors and other authorized study personnel can access and search for archived clinical trial documentation online instantly, without the time consuming job of sifting manually through paper records in a physical storage facility.
- Save time and complete trials in less time
- Lower clinical trial costs
- Enhance clinical trial document quality and integrity
- Deploy eTMF on new studies in days not months with SureClinical Secure Cloud
- Integrated suite of applications for quality, compliance, medical imaging and more using an open, standards-based platform that integrates with most popular content management solutions
- Automate manual paper handling processes for higher electronic document and eRecord quality
- SureClinical’s Triple-View™ provides users a view of the document hierarchy, metadata and document viewing in a single view
- Advanced search and reporting capabilities with custom reports by site, by person, by study subject and custom reports
- Create collections of content and share it securely with internal or external team members using secure content sharing technology
- SureDesigner content model tool enables rapid customization to maximize flexibility and interoperability
- Flexible set of predefined views for clinical trials or create your own custom views with the view wizard
- Web downloadable desktop clients for Windows PCs or Apple Mac OS
- Support for both online or offline operation
Eliminate paper at the point of creation – deploy SureClinical eTMF cloud for clinical trials.