Electronic Trial Master File Archive
Completed Study eTMF Archive
SureArchive is an Electronic Trial Master File (ETMF) Cloud Archiving service. SureArchive 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. An indelible audit trail and audit report is provided for inspection readiness by agencies.
With data centers that are continuously independently FDA Part 11, EU Annex 11 and HIPAA compliance validated, and standards based data storage, SureArchive is your trusted partner in long term study data archiving. SureClinical Services can assist in migrating existing digital or paper study documents and data to SureArchive.
Certified Study Archiving
Ensure Clinical Study Archive Integrity
In addition to storing documentation online, SureETMF and SureArchive both allow for documents to be exported at any time to various standard formats, including the well-established ZIP/HTML/PDF and PDF Portfolio formats, at no extra charge. Securing exported documents is easy with the integrated archive encryption feature, helping to ensure compliance with HIPAA and other regulatory compliance laws requiring data security and privacy. File content tree structures, documents and associated metadata are included in these portable exports, enabling large archives to be burned to golden DVD’s for added redundancy, long term storage and risk management.
The need for affordable, stable, long term archiving solutions mandates a multimedia approach: Both cloud and offline methods using ISO-32000 standard PDF based content archiving are recommended to ensure long term data access and availability to inspectors. Typically the FDA requires sponsors to retain clinical trial documentation for a period of two years post marketing approval, whereas the Canadian GCP and EU may stipulate that sponsors retain clinical trial documents for a period of twenty five years.
The exports of digitally-signed documents and records to a digitally-signed PDF portfolio format using SureEsign, provides additional archive integrity and assurance of the originating party. This technology is referred to as SureClinical’s Certified Archive™ format. A certified archive is a collection of PDF documents and clinical trial metadata records that are digitally signed by the originator with an encrypted Adobe Digital Certificate, sealing and certifying the entire clinical archive. Our Certified Archive uses the same technology required by the FDA for online device and drug application submissions. The certified archive can be viewed by any third party recipient in both online and offline modes via the SureArchive cloud service or in Adobe Reader. When the recipient opens a digitally signed archived document, all documents are tested for integrity to determine if they have been modified since creation. The archive author’s identity can be verified by the viewer through a third party certificate authority, similar to how an SSL certificate is used to verify the identity of a website.
Features
On Demand Study Document Access
Online, secure read-only access to archived clinical trial documents for viewing and sharing content.
Wizard based creation of a secure clinical Certified Archive™ from cloud documents and records.
Create a digitally-signed Certified Archive™ which ensures clinical study archive integrity, reliability, using Adobe Digital Certificate signing, the gold standard in content integrity and authentication.
Integrated trust verification feature lets recipients instantly verify who created the archives.
Encryption of archives using NIST standard encryption, is both FDA and HIPAA compliant, ensuring security when sharing archives.
Export wizard enables bulk save and export of archived documents to PDF, HTML and XML formats.
Export to multiple standards based formats, including Adobe PDF, HTML format (.ZIP) and more.
View archives in SureArchive, Adobe Reader, or any standard Web browser.
Full use setup and configuration period for establishing the SureArchive repository prior to study data lock. After study data lock, the system becomes read-only.
Benefits
Immediate ROI
Cut clinical trial operations costs through automated business processes
Gain an immediate return on investment
Save staff time and hassle through outsourced operations
Accelerate clinical product delivery through reduced time to market
Data Center Certifications
FDA Part 11, EC Annex 11, GDPR and more
FDA CFR Part 11 Application Certification: SureClinical cloud applications are independently audited and validated across all global data centers through an ongoing program of continuous QA, validation and certification. These in-depth evaluations of our cloud applications and cloud infrastructure are done against a rigorous set of FDA regulations. Ask for a free copy of our independent FDA Part 11 compliance opinion letter and certification.
HIPAA Business Associate: SureClinical maintains policies and procedures necessary to act as a HIPAA Business Associate for customers whose application maintains data covered by HIPAA regulations.
SOC 1, SOC 2, SOC 3 Compliance: Support for all major AICPA SOC compliance certifications with independent audit opinion letters continually updated.
SSAE-16 Type I and Type II Attestation: Support for both SSAE-16 Type I and Type II attestations in conjunction with auditor SSAE 16 Solutions.
EU GDPR Certification: SureClinical is committed to privacy protection. SureClinical’s applications and data centers are fully GDPR compliant. We maintain GDPR compliance through our policies, training and application features that protect privacy under applicable GDPR regulations.
PCI Compliance: Maintenance of a PCI-compliant environment. Certification is optional for customers who purchase the PCI compliance service.
U.S. Commerce Department Safe Harbor Certification: SureClinical’s cloud is certified under the U.S Commerce Department’s Safe Harbor program, which signifies that the SureClinical cloud employs policies and procedures that meet the privacy standards of the European Commission’s Directive on Data Protection. By certifying under the program, SureClinical’s customers can be assured that their personal information is private and protected.
FIPS-140-2 Level 3 compliance: SureClinical’s Certified Cloud is the first cloud solution for health sciences to offer a secure cloud-based digital signing service that enables investigators to electronically sign documents outside the firewall making 100% paperless operations a physical reality. Our patent-pending signing services support digital certificate signing (PKI x.509). All PKI signing transactions utilize US NIST tested and approved FIPS-140-2 Level 3 technologies.
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