R&D and Clinical Trial


R&DExpert is an advanced solution which consists of pre-configured set of business processes addressing document, content, and workflow management needs, as well as project planning and tracking needs in the product development area.

With this solution, users can plan and manage documents up to submission readiness. Combined with other modules from our Life Sciences Suite – SubmissionExpert and RIMExpert – this solution offers the functionality to find out where (in which submissions) a specific document (or version) has been used, at any time. Document distribution covers delivering documents to all participants in the process and to other users of this corporate information system. Document control is implemented, and the document lifecycle, roles, workflows and forms are predefined for all documents comprised in the dossier, including automatic prompting and reporting.

FEATURES

R&DExpert promotes cross-functional collaboration within and outside the company, and enables you to replace multiple siloed applications and establish a single authoritative R&D asset repository.

Planning

Pilot development

Process validation

Packaging materials

Stability testing

Formulation development

Manufacturing procedure

Batch records

Labelling

Project management

Achieve established milestones and product launch objectives

BENEFITS

Achieve established milestones and product launch objectives. Provide timely and accurate reports to senior management regarding the status of new product development projects.

LEAVE LEGACY SYSTEMS BEHIND
LEAVE LEGACY SYSTEMS BEHIND

Do not rely on dispersed tools. Get rid of siloed applications and allow your business to flow faster using integral R&D asset repository. Streamline the time to market.

EASILY PLAN AND TRACK ACTIVITIES
EASILY PLAN AND TRACK ACTIVITIES

Manage, track, and communicate project activities, timelines, progress and deliverables among core team members and management.

PREPARE HIGH-QUALITY DOCUMENTATION, WITHOUT DELAYS
PREPARE HIGH-QUALITY DOCUMENTATION, WITHOUT DELAYS

Drive consistency, quality, and process standardization across all phases of R&D in a collaborative way. Ensure adherence with FDA, EMA, and other regional regulations and standards.

LIFE SCIENCES SOLUTIONS

ProductExpert

ProductExpert is part of AMPLEXOR Life Sciences Suite. It is the first ISO IDMP compliant solution available on the market that enables users to meet IDMP related requirements.

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R&DExpert

R&DExpert is the most advanced and highly flexible solution, which enables users to efficiently manage R&D project and document management, including trial management. One environment. One authoritative source of truth.

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QualityExpert

QualityExpert is part of AMPLEXOR Life Sciences Suite. It enables users to manage all QA/QC processes and documents through a single user-friendly interface in one environment.

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RIMExpert

RIMExpert is part of AMPLEXOR Life Sciences Suite. It is a business intelligence tool designed to standardize the data management process across your company and product lifecycle.

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SubmissionExpert

SubmissionExpert is part of AMPLEXOR Life Sciences Suite. It is the most advanced solution that helps users create, compile, and manage regulatory submissions and publishing.

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