Mediscribe is a healthcare company but focused extensively on technology orientation of Drug safety / Pharmacovigilance domain. A dedicated division of Mediscribe is currently focused on technology orientation in drug safety and pharmacovigilance. Specialists at Mediscribe combine their pharmacovigilance and information technology proficiency by stringently adhering to the current regulations of FDA, EMEA and PMDA thereby aiding pharmaceutical and life science companies meet achievements in pharmacovigilance with ease.

Our Expertise

Mediscribe’s pharmacovigilance team constitutes of individuals with industry expertise in Oracle health sciences

• Oracle Argus safety
• Oracle Argus interchange
• Oracle Argus insight
• Oracle Empirica signal
• Oracle Argus Perceptive
• Oracle Argus Affiliate

Mediscribe services and solutions are delivered with precise, timely and cost effective execution helping clients achieve and sustain regulatory compliance and manage risk.

Additionally, Mediscribe team support for the implementation of Argus safety-Japan enables global Pharmaceutical companies to fully integrate Argus Japanese model into their worldwide business process, enabling significant productivity benefits.

Mediscribe Core Services:

Our Pharmacovigilance techno-functional consultants understand business challenges and provide customized services for clients including

Implementation and Up gradation

• Implementation and installations of safety databases such as Oracle Argus safety suite, ArisGlobal ARISg, Oracle AERS, Oracle Empirica signal
• Medical dictionary’s (MedDRA and WHO-DD) up gradation
• Installation of E2B gateway such as Axway cyclone and BizTalk

Testing and Validation

• Validation strategy and planning
• Validation scripts development and execution such as IQ, OQ and PQ
• UAT planning and execution

Application Administration and configuration

• Console Access management configuration such as user accounts, including roles, privileges and security
• Configure business work flow and process such as Business, system and code list

Product support

• Support for import, export, and tracking of ICSRs via the E2B standard, ensuring cases are reported instantly and accurately.
• Complete product support with 24*7* 365 days availability

Data Migration

• Perform data migration from 2 different versions of Argus Safety
• Perform data migration from two different applications (old to new) such as
  Oracle Argus Safety, ArisGlobal ARISg, AERS and Emprica Trace etc…

Data Integration
Mediscribe provides services for integration of Oracle health sciences products such as

• Argus Safety and Siebel Clinical Trial Management System (CTMS)
• Argus Safety and Oracle clinical
• Argus Safety with inform
• Integration of Clinical (OC/RDC/TMS) data and Argus safety data into oracle Life Sciences Data Hub (LSH)
• Clinical, Pharmacovigilance and Healthcare Data warehouse