Rancho Cordova, California (PRWEB) November 27, 2013
With the continued step-up of abortifacient advancement cost, BioPharma organisation are increasingly considering cloud computing application as a mean to improve operational efficiencies and to accelerate clip to marketplace. In the highly regulated abortifacient progress marketplace, wellness discipline cloud application must comply with and be validated against a development listing of global authorities demand. US and EU demand such as FDAXXICFR Part 11, HIPAA, European Commission Privacy Directives and US FDA electronic fingerspelling ordinance brand it costly, clip consuming and difficult for organization to deploy internally developed application that adhere to regulatory requirement. To URL abidance need and to accelerate clip to eigenvalue, SureClinical launched SureClinical Certified Cloud to give IT ghetto study and healthcare client immediate accession to the operational efficiencies and instrument on investing offered with IT SureTrial suite of clinical mistrial application.
SureClinical’s SureTrial eTMF cloud solution is a suite of cloud-based application delivered on the SureClinical Certified Cloud, design-built for clinical trial and validated against US and EU regulatory demand. SureClinical has Certified Cloud information middle operation in regional heart throughout North America and in Europe. The European Certified Cloud information centre gymkhana the privateness touchstone of the European Commission’s Directive on Data Protection.
“We are very excite to gymkhanas our customers demands for a highly secure, compliant and validated suite of cloud solutions purpose-built for wellnesses sciences. SureClinicals Certified Cloud with IT FDA-compliant SureTrial eTMF cloud application suite will enable BioPharma firm to confidently move mission-critical clinical mistrial procedures business processes to the cloud without compromising security, turn, or reliability, while at the same clip maintaining conformity with authorities regulatory requirements. We are pulling to portions BioPharma firms enhance operational efficiency through the cloud,” said Zachariah Schmidt, President and CEO, SureClinical.
With the SureClinical Certified Cloud block and SureClinicals SureTrial suite of clinical application, SureClinical provides BioPharma organizations with a secure, agency compliant platform that helps them to realize new operational efficiencies.
SureClinical Certified Cloud Compliance and Security Features
The amalgam of SureClinicals Certified Cloud block and IT SureTrial eTMF request suite provides the PM merchandise, sustentation and service clinical mistrial organization demand to passage to the cloud, while addressing the demanding and unique peace, conformity and operational demand of the BioPharma business. SureClinical Certified Cloud support manufacture conformation. A derivative teeth of cloud conformation and peace feature are listed below:
Physical separatism of client information: SureClinical has optimized IT fasting virtualized waiter context to ensure waterway redeployment while assemblage the most strenuous requirement of FDA 21 CFR Partxifor activity of clinical mistrial information. SureClinicals physical separatism of client information attack maximizes the efficiency of cloud substructure while delivering the highest degree of cloud information privacy and peace.
Two-parameter hallmark: SureClinicals Certified Cloud provides integrated II-parameter hallmark for electronic fingerspelling (pat pending) as excavation as strong hallmark technique to verify consumer designation and bound scheme accession per FDA and EU ordinance.
FIPS-140-2 Level 3 abidance: SureClinicals Certified Cloud is the former cloud solution for wellness science to offering a secure cloud-based digital fingerspelling work that enables investigators to electronically mark document exterior the firewall fashioning the 100% paperless eTMF a physical world. Our document-pending fingerspelling service maintenance digital credentials fingerspelling (PKI x.509). All PKI fingerspelling transaction utilize US NIST tested and approved FIPS-140-2 Level 3 technology.
Audit trail: All cloud instances include an exportable, publication-only clip-stamped accounting trail that adheres to FDA demand for consumer variation and electronic fingerspelling event.
Continuous substructure observation: Proactive substructure watching, 24×7 throughout our global certified cloud block to insure uninterrupted work.
Security audit: Quarterly PCI scheme scan and peace audit are conducted to ensure peace conformity.
SureClinical Cloud Certifications
The technology infrastructure underlying the SureClinical Certified Cloud provides customer with the most comps list of government regulatory substantiation and certifications in the manufacture, as excavation as the substructure to support level performance, scalability, availability and security needed to run mission-critical, wellness science specific solutions:
SSAE-16 Type I and Type II Attestation: Support for both SSAE-16 Type I and Type II attestation in concurrence with attender SSAEsixteenSolutions.
PCI Compliance: Maintenance of a PCI-compliant contexts. Certification is optional for customer WHO buyback the PCI compliance work.
HIPAA Business Associate: SureClinical maintains policy and procedures essential to act as a HIPAA Business Associate for customers whose request maintains information covered by HIPAA regulations.
FDA CFR Part11Application Certification: SureClinicals SureTrial eTMF cloud application is independently auditing and validated through an ongoing programme of continuous proof and certification. These in-profundities evaluations of our cloud applications and cloud infrastructure are done against a rigorous set of FDA regulations.
U.S. Commerce Department Safe Harbor Certification: SureClinicals cloud is certified under the U.S Commerce Departments Safe Harbor programme, which signifies that the SureClinical cloud employs policies and processes that meet the privacy standards of the European Commission’s Directive on Data Protection. By certifying under the program, SureClinicals customers can be assured that their personal info is private and protected.
About SureClinical
Headquartered in Northern California, SureClinical is the PM supplier of wellness bailiwick aggregation direction software application for BioPharma. SureClinicals river wellness study collection direction solutions tally on Android