LifeSphere eTMF Reviews

Streamline your clinical studies with Clinvigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us for thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The Clinvigilant eClinical suite includes: EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. Every interaction and data exchange creates Audit Trails, which provide compliant real-time data visibility across all relevant roles. Our products are modular, highly customizable, and available on the web, iPad, and Mobile App for both Android and iOS. We also support Patient's Own Device (BYOD) and interface with Devices and Wearables. Clinvigilant💊, your one-stop🌐solutions provider for clinical trials☁️ .

Streamline regulatory operations within your organization to improve compliance. Veeva SiteVault simplifies clinical trial management by connecting all regulatory operations. This improves efficiency and compliance. A single system that integrates regulatory and source documents supports 21 CFR Part 11 compliance and HIPAA requirements. SiteVault Enterprise provides real-time visibility across trials and speeds study activation. It also enables faster and more quality trial execution. To speed up study activation and reduce manual work, you can replace manual processes with your own workflows. Monitors will have secure, direct access into your source and regulatory documents. This will eliminate the need to redact or grant EMR access. You can create your own workflows, reports and dashboards to gain greater insight into regulatory processes and start-up timelines.