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Regulatory LifeSphere Investigational Product (IP RIMS)

LifeSphere Investigational Product is a “right sized” RIMS solution

Reduce complexity by focusing on investigational submissions, clinical trial authorization and health authority commitments

OVERVIEW

Realize a greater return on your initial investment by focusing on the high-impact capabilities your company needs at this stage of clinical drug development, implementing a pre-validated, turnkey solution in weeks, not months, and establishing a strong regulatory foundation that will yield future savings and support growth.

LifeSphere Investigational Product allows you to:

  • Comply with global regulatory and international product data standards from the start
  • Align your authoring plan with your regulatory submission outline directly in RIMS
  • Improve cross-functional and third-party collaboration
  • Effectively manage and track health authority commitments
  • Step into powerful functionality like global product registration tracking when you’re ready
Benefits

Discover how LifeSphere Investigational Product RIMS adds value

LifeSphere Regulatory Submission Process List

Enable more effective collaboration

Cross-functional teams have 360° visibility to project- and task-level deadlines and status updates through dashboards and reporting in a single interface. Additionally, interoperability with third-party technologies promotes collaboration with partners like Contract Research Organizations (CROs).

LifeSphere Regulatory Dashboard

Speed to value

Focus on what’s right in front of you with purpose-built functionality to lower initial costs, a pre-validated, turnkey solution that can be implemented in weeks, not months, and a renewable annual contract term that gives you the ability to convert a short-term investment into sustained success.

LifeSphere Regulatory Precise Automation

Investor-ready product assets

By establishing compliance with global data standards and naming conventions for the exchange of information and storing approved investigational submission content in a validated system, investigational-stage companies can present a more polished package of product assets to potential investors and commercialization partners.

LifeSphere Regulatory Overview

Condensed marketing authorization timeline

As you receive the green light from health authorities, quickly repurpose approved investigational submission content for your marketing applications worldwide.

LifeSphere Regulatory Overview

Step into robust functionality

Harness the full power of LifeSphere Regulatory by simply upgrading your license to step into the more complex capabilities needed to manage marketing authorizations and track global product registrations. There’s no need to migrate data, rebuild workflows and import data standards.

Seeing is believing

Schedule a LifeSphere Regulatory Investigational Product RIMS demo to see how functionality is tailored to the needs of life sciences companies working through the clinical phases of drug development.

Features

Purpose-built for investigational-stage companies

LifeSphere Investigational Product is purpose-built with the functionality you need today, nothing more. Organizational complexity and cost are reduced by focusing on high-priority capabilities like investigational submission and dossier planning, clinical trial authorization tracking, and health authority commitment management.

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Investigational submission and dossier planning

with precision automation and activity triggers to drive efficiency

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Clinical trial authorization tracking

to meet regulatory deadlines and expedite time to market

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Health authority commitment management

for end-to-end planning and tracking of interactions, commitments, and obligations

Why

Don’t Take Our Word for It, Here’s What Industry Voices Say about LifeSphere Regulatory

No matter your size, your organization is in good company. LifeSphere Regulatory services over 30 customers worldwide, including 4 of the top 20 life sciences organizations. Validated by industry-leading voices, your organization can trust that LifeSphere Regulatory provides modern solutions that are forward-thinking and ready to grow with your organization

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Gens & Associates IDMP Readiness Review

LifeSphere Regulatory IDMP is ranked number one in IDMP readiness out of all vendors on this review ahead of the 2023 implementation deadline and worked within the industry to enable customers with internal experts.

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Frost & Sullivan Customer Value Leadership

LifeSphere solutions in both Regulatory and Clinical are recognized for their customer value in North America as a cloud-enabled, data-first customer solution in Life Sciences.

Resources

Resources for Your Regulatory Journey

Checklist: What to Look for in Your Investigational Product RIMS Solution

Investigational-stage firms that invest in their own RIMS solution early on can drive efficiencies, ensure future market readiness, and adapt to changing regulatory requirements.

Webinar: 'Right-Sized' RIMS

Join ArisGlobal leaders to discover how a regulatory information management solution tailored to investigational-stage company needs can reduce complexity and provide immediate value.

Fact Sheet: LifeSphere Investigational Product 

Purpose built RIMS with the critical functionality life sciences companies and their partners need during the clinical phases of drug development.

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