Phase IV Trials & Post Marketing Research

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Undoubtedly, Phase IV trials are the fastest-growing area of clinical research today. At an annual growth rate of 24%, companies are investing in post-marketing research and the totals will probably reach $12 billion in this year alone.

Why Now?

The regulatory environment is constantly changing. New concerns about the safety of new medicines, and various uses for large-scale, real-world data on marketed drugs' patient safety and efficacy, as well as, new combination and comcomitant therapies are the primary growth "drivers".

Post-marketing research is a critical element of pharmaceutical marketiing - enabling companies to expand existing markets, enter new markets, develop and deliver value-add messaging that differentiates their products with the competition, creating a niche position in already crowded markets. The fact is, regulators are requiring more post-marketing data from drug companies, which makes absolute sense.

Given the increasing importance of phase IV trial research, increased competition and a real need for a rapid understanding of how their drugs are performing in the real-world, it is mission critical for companies to integrate a strong data capture and analysis tool or "system" to help them truly understand statistical trends and patient outcomes.

ClinicalQuest, GVT's strategic patient registry software program is a great answer to the question... "How can I collect real-time data... securely and rapidly, from physician sites that are using our drugs?"

Items to consider for your Phase IV Trials:

	HIPAA compliant/patient privacy
	Secure, private electronic data capture to help satisfy Part 11 of Title 21 of the Code of Federal
	Regulations; Electronic Records; Electronic Signatures
	Rapid data collection instrument
	Remove resistance barriers / user friendly
	Strong statistical and analysis tools
	Able to collect Serious Adverse Event and Safety data
	Real-time data collection and analysis
	Security
	Patient Compliance Adherence Tools