Solutions

All of our solutions are off-the-shelf ready, offered in the cloud, and are fully compliant with FDA regulations.

Biostatistical Programming Studio (BPS)

Get biostatistical data programmed, validated, and reviewed from a single and easy interface.

BPS is the only statistical computing environment (SCE) on the market that directly interacts with SAS and optimizes your SAS programming environment while offering compliance, efficiency, and standardization.

BPS fills the gap between the limitation of metadata in Windows or Linux where SAS is typically installed and the regulatory requirements. BPS brings in automations and streamlines workflows, which makes collaboration in BPS truly a breeze. From one single interface, programmers, statisticians, and management get their job done.

Benefits

Hassle-free compliance: BPS is 21 CFR part 11 compliant, and the system is always audit ready.

Efficiency: BPS is a one-stop shop that reduces your workload through automation and standardization.

Easy Collaboration: BPS’s system notification, in-app instant messaging, and in-app permission management make collaboration seamless.

Related Functions: Biostatistical Programming, Biostatistics, Data Management, Biometrics, Clinical, etc.

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Nonclinical Study Tracker (NCST)

Access nonclinical studies and full documentation in just a couple of clicks.

NCST brings you total control over nonclinical studies/sub-studies and compliance to Master Schedule and 21 CFR Part 11/EU Annex 11 requirements. Whether it is GLP/Non-GLP or conducted by Sponsor/CRO, you can easily track real-time status and access any relevant information and study documentation, all within 1-2 clicks. Study finance gives you ability to monitor if study spending is on track with study progress, while forecast function allows you to plan future study resource requirements.

Benefits

Flexible: Easy to create custom fields and study reports. Capable of tracking any information.

Efficient: One web application that meets the study management needs for your entire nonclinical team.

Robust: The system is accessible from any device anywhere, can scale up from a few studies to tens of thousands of studies, is ready for inspection at any time.

Organized: Manage the study documents that include reports, summaries, data, protocols, amendments, literature, and admin with full audit trail. All information is accessible within clicks.

Related Functions:  Toxicology, Pharmacokinetics, Pharmacology, Bioanalytical Research/Development, Research, etc.

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Biodigital Library (BDL)

Literature lifecycle management just got easier.

BDL is the industry’s first end-to-end literature life cycle management web app dedicated to the life science vertical. It streamlines the drug development and commercialization processes across all relevant functions to fully utilize literature and manage digital knowledge. BDL allows you to search, purchase if needed, and access full text articles within minutes instead of hours or days, without the hassle of a credit card. Our solution also allows you to remain compliant when sharing literature with 3rd parties. And, with BDL’s private interface, business development team can keep literature for a potential program confidential until it can be publicized.

Benefits

Fast: Instant access to your existing full text articles and acquire new full text quickly in minutes and without having to provide your payment information.

Convenient & compliant: Share literature internally with your team or externally with clinical sites or other external collaborators, knowing you are compliant with the copyright and Sunshine Act. It’s easy in BDL to tag submission-ready versions and use them for regulatory submissions.

Accessibility: Easy to create small libraries for your group and insert citations from your library into their writing; the application is securely accessible from any device anywhere.

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Recently Released Applications

Site Training and Document Review (SiteTrained)

We made site training easy. You don’t have to travel to sites to get the job done.

SiteTrained streamlines the site training process, either self-paced or instructor-led. It makes the entire training, quizzing, certification issuing incredibly simple. Our solution offers training materials management, site personnel and study training resources management, and quiz creation and certificate management once passing quiz.

SiteTrained also lets you perform site document review and offers instant notification on workflow status change, quickly identify and track any issues within testing CRF forms and resolve those issues efficiently.

Benefits

Simple: Quiz creation and certification management has never been easier.

Intuitive: Study training resource planning and site personnel management features will have you up and running in no time.

Full control: You decide who has access to the information. An audit trail will help you stay in charge.

Related Functions:  Clinical, Medical Affairs, etc.

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Electronic Trial Master File (eTMF)

Built on best practices of industry experts to keep you fully compliant.

Viitai implements eTMF in a different way than other vendors. Our solution features automatic metadata population and easier review/approval workflow.

Our solution is built upon the standard eTMF Reference Model 3.0 and utilizes the best practices from industry TMF experts in processing trial master files. With full audit trail, digital signature and status reports, you can ensure you’re always ready for audits and inspections.

Benefits

Less work: Why spend hours populating metadata when uploading documents? We’ll do all the heavy lifting for you.

Better security: Control access using role-based security.

Efficient management: Manage study, country, and site level binders.

Related Functions:  Clinical, Medical Affairs, Regulatory, etc.

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Regulatory (ChronoLog)

Stay on top of submissions and related correspondence all the time.

ChronoLog can help you track and manage hundreds or even thousands of submissions and more related correspondence efficiently. If you’ve been tracking and managing using Excel, ChronoLog is about to make your life easier. If you have key team members leave your organization, no problem, ChronoLog covers it for you.

Benefits

Comprehensive tracking: Track everything about a regulatory submission either by internal resources or by a 3rd-party CRO as well as all related correspondence.

Full reporting: Easily create annual reports and customizable chronological reports.

Alerts: Never miss a deadline enforced by regulatory agencies.

Related Functions:  Regulatory, etc.

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Medical Writing Management (mWrite)

Imagine literature references, data, and TLFs are at your fingertips.

Medical writing involves writing scientific documents of different types, including regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, content for healthcare websites, health-related magazines or news articles. Gathering sources for all of this content can be a real nightmare.

mWrite organizes all of your source documents so they are readily accessed. You can track documents by study, milestone, author, status and more, and have a complete version history and auditing trail. Additionally, if working together with BDL, mWrite offers a brand-new way of writing effortlessly.

Benefits

Customizable: You decide how you want to track your source documents.

Instant: Have instant access to any document you need.

Secure: Lock documents to prevent unwanted changes, plus have complete control over who can edit and view them.

Related Functions:  Medical Writing, etc.

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Aggregate Spend Compliance Analytics (ASCA)

Stay compliant and avoid penalties with comprehensive transactional reporting.

History proves that violation of the Sunshine ACT or Transparency law could incur heavy penalties. ASC is an easy, secure and scalable cloud application that helps life science organizations report transactions with healthcare professionals (HCPs) to stay compliant with the regulatory agencies from around the world.

Benefits

Never lose sleep: No more need to worry that your organization has unreported transactions or that someone changed the records without your knowledge.

Robust organization: In case of an audit, easily find the details of the transactions as required by regulations.

Comprehensive reporting: View status of compliance at a glance.

Related Functions:  Enterprise

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