Clinical Trials Requirements

While Clinical study requirements vary from country to country and type of product, the need for more and more data  to ensure patient safety and efficacy will be ongoing.

Vistaar covers Pre-clinical testing requirements, clinical needs, application needs, documents needed for submission, clinical safety requirements, clinical IMP procedures and several other data points.

Vistaar also provides access to global clinical research information covering drugs, biologics, vaccines, devices, and diagnostics. Clin Intel helps global health researchers and Bio-pharmaceutical companies to better understand trial design trends to empower data-driven development and portfolio strategy decisions using insights spanning 750k clinical trials globally.

Marketing Approval

Health agencies have different requirements and guidelines for approvals that vary based on the product’s nature and the regulatory authority’s assessment.

Vistaar covers regulatory pathway, options based on product type, dossier applications submission process, checklists of documents needed, formats to be followed, fee, timelines and several other data points that are essential for the marketing of the product.

When any changes happen in any country, you can be sure of not missing those updates from Vistaar.

Post-Approval / Life Cycle Requirements

As part of life cycle and post-approval changes, Vistaar covers regulatory requirements for product safety reporting, vigilance, renewals, variations, filing requirements, fee, timelines and change approvals. Ensure to stay to keep product compliance in each country minimizing risks.

CMC

Vistaar provides details for all your CMC requirements and scenarios pertaining to Pharma and Biologics.

• Covers regulatory requirements for CMC spanning Clinical IMP to Registration and Post-Approval requirements
• Search side-side-by side and download comparison reports
• Granular details included 50+ CMC data points
• For Post-approval, search by change (use either free-text or filters) to get change specific requirements and documentation needed for submissions
• Health Authority documents included as well
• Do your change impact assessments faster
• Be sure about the CMC requirements for various countries and different scenarios

Labeling

Every health agency looks very closely on labeling as it directly impacts patient safety and most companies fall short in label compliance. Leverage Vistaar to ensure you get all label requirements, content needs, when to submit changes, primary/secondary labeling, machine-to-machine options (XML, UDI, etc), and other steps involved.

In addition, Vistaar also database of over 300k approved labels (both drugs and devices) pre-loaded and updated daily from Canada, USA, UK and EU. You can subscribe to alerts when new labels matching your criteria added in DB. Compare Labels by drug exposure and clinical response variability, mechanisms of drug action, polymorphic drug target, genotype-based dosing, disposition pathways, risk for adverse events, precautions/alerts, drug–drug interactions, contraindications, and nutritional management across the medicines and medicinal products.

Standards

Keeping up to date with required standards is key for medical devices to be compliant in different countries. As standards are developed by several agencies/bodies, keeping track of all the associated questions as who’s updating and what is being updated has always been a manual and time-consuming task. Vistaar Standards module keeps you current on the standards on each and every update along with the current versions with extensive details.

Ingredients Database

A detailed database covering cosmetic, dietary and food additives ingredients. This database is designed to empower food manufacturers, nutritionists, and consumers with accurate, up-to-date information on a wide range of ingredients. Whether you're seeking details for product development, regulatory compliance, or simply making informed choices, our database help you accomplish those goals.

Features of Our Database:

1. Extensive Library

   Explore a vast collection of cosmetic, dietary and food additives, including preservatives, colorants, emulsifiers, sweeteners, and more. This library is updated continuously to and alerted to users when changes happen.

2. Detailed metadata:

   Access in-depth information about each ingredient, including its Alternate Names, Maximum Permissible Limits, Permissible Claims, Categories, Functional Class, INS/CAS numbers and Warnings and Precautions.

3. Search and Filter Functionality

   Efficiently navigate through the database with our user-friendly search and filter options. Find specific ingredients, explore categories, or refine your search based on regulatory specifications.