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SureClinical eTMF validation

SureClinical eTMF
FDA, EC and HIPAA compliance validated electronic trial master file application
Automate your clinical study with Adobe digital signing, task management, medical imaging and more in a cloud portal
Instant activation, zero setup fees, choose a package or customize a solution - buy only what you need to succeed
Enterprise class eTMF app feature set starting as low as $600/month per study
Want to learn more? Call Sales at 916-265-2000 or contact us:More
Select a SureClinical eTMF package by study size:
eTMF 100
Starter eTMF ideal for Phase 1 or Pilot Trials
Up to 2 Sites
4 Adobe eSign users
eTMF 200
Basic eTMF ideal for Phase 2 or Medium Pilot Trials
Up to 4 Sites
8 Adobe eSign users
eTMF 300
Medium Study ideal for Phase 3 or Pivotal Trials
Up to 25 Sites
100 Adobe eSign users
eTMF 400
Large Trials
Up to 50 Sites
100 Adobe eSign users
eTMF 500
Very Large Trials
Up to 100 Sites
200 Adobe eSign users
eTMF Unlimited
Unlimited sites
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SureClinical SNAP Platform
Cloud Storage, Adobe eSigning, Workflows, Compliance Portal, QA and Training Environment
SureDrive: FDA & EC compliance validated content management portal - Save and share files, forms, templates, SOPs and more
Document collaboration, team annotations, tracking, tagging and audit trail. Perfect for use as a QMS / Quality Management System!
Integrated Adobe PDF Digital eSigning with unlimited document signing for up to 30 users/yr (additional signers available)
Automated document review and approve workflows, document eSign, upload workflows and more for internal and external teams
Archive up to 3 clinical trials via SureArchive cloud
Compliance Portal: On demand access to validation docs, cert's, test scripts and reports
QA and training environment: Separate application instance and cloned study data for QA test and training
Certified Cloud Clinical Trial Archiving - FDA & EC Compliance Validated
Cost effective long term online eTMF archiving for completed studies
Access by auditors, inspectors to documents, medical images and reports
Allows addition of content and tagging for first 90 days, then becomes read-only

SureClinical eTMF Application Pricing FAQ

Q: What features are included with each eTMF application package?

A: Regardless of the eTMF application package that you select for your clinical trial study, each eTMF application package includes the same rich set of eTMF cloud options, with support for zero-footprint web, mobile and desktop clients.

Q: What is the fee to setup a trial with SureClinical?

A: Unlike other vendors who charge thousands of dollars and take months to setup a study, we don’t charge any fees for standard study startup — you can create a new study in as little as five minutes with our cloud.

Q: I have multiple clinical studies.  Can I mix eTMF application packages?

A: Yes.  We allow you to select application packages based on the size and phase of your clinical trial need.  You can mix application packages based on your needs.  Regardless of the packages that you select, you get the same feature set for all packages, from a small starter study all the way to a mega-study with thousands of study subjects.

Q: What is SureClinical’s SNAP Platform?

A: SureClincal’s SNAP Platform provides you with a set of FDA & EC compliance validated content management, collaboration, Esigning, workflow and cloud study archiving services including:  SureDrive – Save, share, collaboratively annotate files, forms, templates, SOPs and more in a content management portal;  SureArchive – Study Archiving for completed studies with access by external auditors; SureEsign – Document review, approve, Adobe eSign with automated task tracking and completion for your internal and external team.  Compliance Portal – SureClinical’s online compliance portal with user acceptance test scripts, QA and training instance, and validation documents, accessible via a web portal by auditors.   SureClinical’s SNAP Platform is a required component to license any SureClinical application.

 Q: What is SureArchive?

SureArchive is a cloud-based archiving service for closed studies.  It offers full access to documents, reports, medical images and the study audit trail.   It has a pre-defined limit of three users per study archive. Additional SureArchive users can be added for a fee; please contact us for a quote.

SureClinical eTMF Pricing FAQ

Q: How many studies can we conduct with each package?

A: Each package is priced for a single study. You can add new studies easily on your own with the click of a button at any time. You will only be invoiced for studies that are activated.

Q: How many users/investigators can I have for a study?

A: When you start a study it’s often difficult to estimate how many users you will have, making it difficult to budget. With SureClinical eTMF, we don’t limit the number of users for a study.

Q: How many sites can I have for a study?

A: Each eTMF application packages includes licensing based on the number of sites per study. If you need more sites than we provide for the eTMF application package that you select, you can add additional sites or you can upgrade for a fee (does not apply to the starter package, eTMF 100).

Q: Do I need to buy Adobe digital signing certificates?

A: SureClincal provides digital signing certificates from Adobe.  We provide two types of certificates:  High-trust digital signature certificates that are validated on trust lists for up to 15 years, or our standard certificates.  Other free digital signing certificates on the market are only valid for a year, and then expire, which isn’t consistent with the retention period of clinical documents. We believe this higher trust level is what discriminating clinical practitioners both desire and need to comply with varying regulations across geographies.

Q: Are there overages or hidden fees?

A: In most cases SureClinical provides plenty of space for you to run your studies without any additional fees. However, if you approach or exceed space or bandwidth limits, we may proactively reach out to you to increase your resource utilization package.

Q: What happens at the end of my study?

A: Unlike other cloud vendors, we make it very simple to export your documents and metadata from your eTMF at any time. However, if you maintain your subscription, you can start a new study and can continue to access completed studies in perpetuity.  For completed studies that you wish to lock from further editing, we offer SureArchive, which provides long-term cost-effective cloud storage for access by inspectors, auditors and stakeholders via a portal.   Our goal is that you see the value in maintaining SureClinical’s service for all of your regulatory document needs. This is our commitment to you.

Q: What is the minimum study term?

A:  SureClinical works with our customers to offer flexible licensing terms that work for your organization.  Typical minimum study terms are one year for Phase 2-3.  We’d love to tell you more about our products and packaging. When we get in touch, we will work to create a solution that’s just right for you.

Q: What are the SureClinical training requirements?

A: SureClinical believes that training your staff is critical to your success using our regulatory content platform, and user training is also required by the FDA under 21 CFR Part 11 for compliance. Given the size and complexity of your engagement, we tailor different training packages to fit your needs. All trainees receive a certificate of training completion. We also provide additional services from advance configuration, process re-engineering, form development, program management, to name a few.

Download - High Trust Digital Signing for Health Sciences

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Download - Evaluating Microsoft® SharePoint® based eTMF applications

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Download - Estimating TMF Costs

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Download - Cloud Compliance White Paper

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Download - SureClinical eTMF Flyer

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Download - Enhancing Clinical Trial Operations with Collaborative Cloud Portals

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