Use case

Marketing Authorization in the pharmaceutical industry

Improving the Drug Product File Review and Evaluation Process

Area(s)

BPM, Governance

Sector(s)

Industries & Services

Specialities(s)

Back office and Mail management

Business issue

The process of reviewing and evaluating a pharmaceutical product file, and the authorization granted by a country’s regulatory agencies to support commercialization (Marketing Authorization).

These Marketing authorizations (MA) files include collections of hundreds and thousands of documents which contain detailed administrative, chemical, pre-clinical, and clinical data.

The objective is to build a new platform for these pharmaceutical files and meet the requirements of this highly regulated sector and eCTD processes.

 

Before

Medical content was closely linked to applications.

Data governance needed to be improved.

The performance of the document process display capabilities was insufficient.

Opportunities for annotation and collaboration were not satisfactory.

After

It is now possible to hide, delete, or modify Personal Identification Information (PII) and Protected Health Information (PHI) from data (Digital Imaging and Communications in Medicine (DICOM).

DICOM imaging exams make it possible to work on patient records with different stakeholders.

Health care data are prepared and shared for use in research.

Display and annotation capabilities are efficient, including for large PDF documents, images and videos.

The rendering is dynamic and a new bookmark structure is available.

Different browsers and mobile devices are supported providing more flexibility of use.

Capabilities

  • Implementation of the ARender Viewer.
  • Ability to configure granular security levels.
  • Traceability of the use and modification of documents.
  • Ability to add context to content, collaboratively review critical documents after creating, modifying, and managing shared content.

Gains

Respect for patient privacy.

Increased performance to reach processing limits never before considered possible.

Improved compliance and data security.

Contact us

Areas

$

Dematerialization

$

ECM

$

Business Process Management

$

Robotic Process Automation & IA

$

Compliance

Use Cases

By Specialities

Customer Experience

Accounting / Finance Process
HR Process
Legal Process

Back Office & mail management

IT Management
Cas d’usage
By Sectors

Insurances & Protection

Banking & Financial Services

Industries & Services

Public

Services

$

Consulting & Innovation

$

Solutions design

$

Agile intregration

$

Services Center

Arondor’s Technologies

ARender Content Viewer

FlowerDocs ECM / BPM Platform

Fast2 Migration Platform

Flower Courrier and e-Envelop Solutions

Partners’ Technologies

Strategic Partners

Technology Partners

Outsourced Documentary Processes