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Planning and optimizing Pharmacovigilance requirements:
We can assist you in planning and optimizing the methods and recourses 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 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:
- Oracle AERS
- Medidata Rave’s
- Empirica
Successful Pharmacovigilance plan
- A Pharmacovigilance plan starts with defining process and requirements that comply with major regulatory reporting guidelines, including U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
- Secondly and in a proactive approach it reviews these requirements against any exceptions for other regulatory bodies in countries regulated by other agencies.
- Guarantee 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 tool, it is critical that the software or web solution to support standard dictionaries, including MedDRA, CoSTART, WHO-ART, WHO-DRUG, and ICD-9-CM.