Solutions

Biostatistical Programming Studio (BPS)

Never worry about compliance again.

BPS is the only software on the market that interacts with and optimizes your SAS programming environment while offering 100% compliance, efficiency, and standardization.

BPS closes the gap between traditional documentation methods and compliance so quality assurance is always satisfied. In addition, BPS offers innovative solutions to automation and workflow and makes collaboration a breeze.

Benefits

Hassle-free compliance: Always stay one step ahead of regulatory requirements.

Efficiency: Forget working overtime and reduce your workload with 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.

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 all relevant functions throughout the drug/medical device development and commercialization processes to fully utilize literature and manage digital knowledge. BDL allows you to access relevant articles within minutes instead of hours and without need of a credit card. Our solution also allows you to remain 100% compliant when sharing literature with 3rd parties. And, with BDL’s private interface, your literature remains confidential until you choose for it to go public.

Benefits

Fast: Get full texts quickly and easily and without having to provide your payment information.

Convenient & compliant: Share literature internally with your team or externally with clinical sites, knowing you are compliant with the copyright and Sunshine Act. Tag submission-ready versions and use them for regulatory submissions.

Accessibility: Easily create small libraries for your group, who can then insert citations from your library into their writing.

Nonclinical Study Tracker (NCST)

Access research studies and full documentation in just a few clicks.

NCST brings you total control over nonclinical/bioanalytical/research studies/sub-studies and compliance to Master Schedule and 21 CFR Part 11/EU Annex 11 requirements. Whether it is GLP/Non-GLP or Sponsor/CRO, you can easily track real-time status and access relevant information and study documentation all within 1-2 clicks.

Benefits

Customized: Create a custom study report for all or a certain drug program(s) at any time.

Efficient: Plan your team resources with upcoming studies.

Robust: Track the status of these internally-conducted studies or ones collaborated with CROs.

Organized: Manage the study documents/reports related to each study full audit trail.

Related Functions:  Nonclinical, Research, Bioanalytical Research/Development, etc.

Site Training and Document Review (SiteTrained)

Worried about QA audits and agency inspections? Not anymore.

SiteTrained streamlines the site training process, either self-paced or instructor-led. It makes the entire training/quiz/issuing certification incredibly simple. Our powerful solution offers training materials and processes management, quiz creation and certificate management, and study training resource planning.

SiteTrained lets you perform site document review and offers instant notification on workflow status change. Quickly find 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.

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.

Regulatory (ChronoLog)

Superior tracking at the click of a mouse.

ChronoLog can help you track and manage hundreds or even thousands of submissions and even more related correspondence efficiently. If you’ve been tracking and managing using Excel, ChronoLog is about to make your life easier.

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.

Medical Writing Management (mWrite)

Imagine literature references and tables and figures 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 easily and quickly accessed. You can track documents by study, milestone, author, status and more, and also have a complete version history and auditing trail. And, 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.

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. ASCA 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