SCIMAX ARIN

Response Package Composer

Assembles a complete response package with the appropriate documents, templates, and formats for MedInfo teams to review.

Ease the Flow of Medical Information with Review-Ready Complete Response Packages

Medical Information teams face mounting pressure to deliver accurate, compliant responses faster than ever. Response prep can take hours per submission when considering having to source the right documents, choose the right templates, format everything correctly and remain compliant. The ARIN’s Response Package Composer agent automates this process by dynamically assembling comprehensive response packages with all of the required documentation, templates, and formatting specifically curated for each distinct request.

Key Benefits

Features

Smart Document Selection and Assembly

The agent reads your document library, and looks at the context, the therapeutic area and complexity of each question, and automatically picks the relevant parts of your response past stuff. It smartly integrates into all Standard response templates by inquiry type, therapeutic area supporting documents by indication, Regulatory approved cover letter/disclaimer, and product safety and prescribing information.

Each package is prepared based on your format guidance, so that all responses are consistent yet flexible to unique question requirements.

Dynamic Format Optimization

Response packages are formatted automatically by the agent as sender preferences, regulations, and the type of delivery dictates. It also features multi-regions document compilation (for global searches), channel specific formatting (email, postal, secure portal), Regulatory adjustments (for different markets) and accessibility for multiple healthcare professional requirements. Sophisticated formatting for professional look that is also compliant with local pharmaceutical industry regulations and communication standards.

Quality Assurance and Audit Trail

Inherent quality controls prevent any package of responses from reaching your review that doesn’t meet your organizations standards. The platform includes Automated completeness verification (ensuring no documents are missing), Version control tracking (assuring all documents and templates are current and pre-approved), Audit trail recording (for regulatory compliance and quality assurance), and Real-time analytics (to view assembly patterns and optimization points).

Full logging provides means of the quality control as well as the possibility to continuously optimize the grinding process, aside of regulatory inspections.

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Recommends the most relevant FAQs and response documents to use for fulfilment (based on the question and historical data).

Response Package Composer

Assembles a complete response package with the appropriate documents, templates, and formats for MedInfo teams to review.

Response Fulfilment Engine

Creates and sends a response package to the HCP, including relevant response documents, enclosures, and covering letters.

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Automatically creates AE and PC reports and forwards them to the appropriate end systems or departments for next steps.

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Utilizes predictive analytics using case data to reveal unidentified Adverse Events or Product Complaints.

Retrospective QA Engine

Archived cases are re-reviewed to identify any such Adverse Events and Product Complaints that may have been overlooked during review of the original cases.

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Medical Information Smart Chatbot agent acts as a digital front line, instantly addressing frequently asked medical queries, ensuring regulatory-compliant answers.

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Learn how we can optimize your organization’s Scientific and Medical Affairs Programs with ARIN

Latest Resources

Insights

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Success Stories

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Launching a Global Medical Information System for a BioPharma Company that specializes in Rare Diseases

Announcements

November 14, 2023

JAMP Pharma Group Chooses SciMax Global as Their Medical Information Provider

Events & Webinars

May 2, 2025

Medical Affairs Professional Society EMEA 2025, 12-14 May 2025, London