Pintels Intelligence Analytics platform delivers Pintels BioPharMed Intelligence solutions. The BioPharMed intelligence emcompasses Competitive landscape intelligence, Drug Patent intelligence, Drug Product Intelligence as well as post market drug safety intelligence, Adverse Event Reporting Intelligence, FDA Enforcement Reports including the Product Recalls and Market Withdrawals. Pintels BioPharMed Intelligence also includes FDA Adverse Event Reporting intelligence providing insights to all adverse events and patient outcomes. Leveraging this information businesses can improve the patient outcomes, improve drug safety, detect safety signals and improve drug quality.
Key Challenges:
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Why Pintels BioPharMed Intelligence?
Business Executives are constantly challenged to address competition, improve revenues and generate value for stakeholders. To accomplish this, they need comprehensive information including patents, products and post market safetey intelligence - patient outcomes, adverse event reports, Enforcement reports - Product Recalls and Withdrawals.
The Big Data driven Pintels BioPharMed Intelligence analytics solution provides Analytics on Demand. The analytics include Competitive Intelligence, Drug Patent Intelligence, Drug Product Intelligence, Drug Safety Intelligence - Adverse Event Reporting, Enforcement Reports - Product Recalls & Market Withdrawals, Drug Master Files (DMFs) and Bioresearch Monitoring Information System (BMIS). You can also track competitor patent portfolio, patent families, key technology classes, patent litigation, Drug classes, Active Ingredients, Formulations, Dosages & Administration information. You can also gain deep insights into drug drug interactions (DDI's), Adverse Drug Reactions (ADRs) and Adverse Events such as deaths, disabilities, hospitalization and other serious conditions and thereby improve patient outcomes and increase drug safety.
Another unique aspect of Pintels BioPharMed Intelligence analytics is that you can leverage the deep insights to detect drug safety signals, improve drug effectiveness, reduce medication errors, identify and assess risks, evolve risk mitigation plans as well as creating opportunities to new products and services and improve the health outcomes.
Pintels Intelligence Analytics platform delivers Pintels BioPharMed Intelligence solutions. The BioPharMed intelligence emcompasses Competitive landscape intelligence, Drug Patent intelligence, Drug Product Intelligence as well as post market drug safety intelligence, Adverse Event Reporting Intelligence, FDA Enforcement Reports including the Product Recalls and Market Withdrawals. Pintels BioPharMed Intelligence also includes FDA Adverse Event Reporting intelligence providing insights to all adverse events and patient outcomes. Leveraging this information businesses can improve the patient outcomes, improve drug safety, detect safety signals and improve drug quality.
Patent Intelligence - Provides you indepth information on the patents, patent families, patent technology classes, bibliographic information, patent prosecution history, patent expiration and patient use codes. A key feature of Pintels Intelligence analytics platform is that the patents are mapped to products, providing you not only contextual information but deep insights on patent to product mapping. This potentially reduces the IP Due Diligence time needed during Mergers & Acquisitions.
Drug Product Intelligence:
Pintels BioPharMed intelligence analytics is a comprehensive intelligence tool providing you up-to-date information on all FDA approved products as well as NDC listed products and span across biosimilars to biologics, over-the-counter (OTC) drugs, Prescription (Rx) drugs and generic drug categories. Pintels BioPharMed intelligence analytics provisions indepth information on over 500,000 drug products including - IND applications, NDA applications, ANDA applications, BLA applications, 505 (b)(2), product details, drug dosage, delivery information, drug product labels, revisions, approval letters, manufacturer information, Risk Evaluation and Mitigation Strategy (REMS) and more.
Enforcement Reports:
Pintels Drug Safety Intelligence analytics provide detailed information on drug recalls, market withdrawals and safety alerts across all the FDA regulated products.
Using Pintels Intelligence platform you can leverage information on all the product recalls and market withdrawals either volunteered recalls or FDA enforced withdrawals across not only drugs but also biologics, medical devices and cosmetics.
FDA Adverse Event Reporting System:
Pintels Drug Safety Intelligence provisions FDA Adverse Event Reporting System (FAERS), providing the data on patient outcomes especially the cases with death, disabilities or hospitalization events, drug-drug interactions (DDI's), Adverse Drug Reactions (ADR's).
The patient outcomes are defined as per the U.S. reporting regulations (21 CFR 310.305, 314.80, 314.98, 600.80) and Forms FDA 3500 and 3500A. All the cases reported in these formats can be instantly leveraged using Pintels Drug Safety Intelligence analytics.
Drug Master File (DMF):
Pintels Safety Intelligence provisions Drug Master File (DMF) data. This data encompasses confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Another unique aspect of Pintels intelligence platform is that it provides collaboration with eCTD Submission Management tool and using the Electronic Common Technical Document (eCTD) DMF submissions can be expedited making it win-win for customers.
Bioresearch Monitoring Information System (BMIS):
Pintels Safety Intelligence tools encompasses Bioresearch Monitoring Information System (BMIS) Data. Leveraging this tool, the clinical research community, CRO's can get clinical research information. This includes information with respect to clinical investigators, contract research organizations, and institutional review boards involved in the conduct of FDA Investigational New Drug (IND) studies with human investigational drugs and therapeutic biologics.