MPR provides comprehensive services in all aspects of adverse events processing and reporting for drugs, biologics and medical devices, whether in clinical trials or after approval.

 

Planning and Optimizing Pharmacovigilance Requirements

 

We can assist you in planning and optimizing the methods and resources needed to meet safety reporting requirements. Whether your project involves one regulatory body or several, we can optimize a cost effective model that utilizes appropriate technologies and tools to meet your requirements.

 

Pharmacovigilance Reporting and Processing Tools

 

Whether you have your own in-house solution or you would like to use a commercial tool, our experienced IT and operational staff can compliment your project and assist you to meet your requirements. We are not biased to any tool and we do not advocate any specific solution, realizing that each available software has certain strengths. We support all available pharmacovigilance solutions including:

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• Oracle AERS

• Medidata Rave

• Empirica

 

Successful Pharmacovigilance Plan

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• A pharmacovigilance plan starts with defining process and requirements that comply with major regulatory reporting guidelines, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

• In a proactive approach it reviews these requirements against any exceptions for other regulatory bodies in countries regulated by other agencies.

• Guarantees integration and Interchange between sponsor and  companies to exchange information with regulators.

• The plan has to be scalable and most importantly flexible, especially when used to report events in locations with limited resources or primitive infrastructure.

• When using electronic tools, it is critical that the software or web solution supports standard dictionaries, including MedDRA, CoSTART, WHO-ART, WHO-DRUG and ICD-9-CM.