Phase IV Trials Software

Phase IV Clinical Trials Research & Post Marketing Research Software

 

Phase IV ResearchUndoubtedly, Phase IV clinical trials and Post Marketing Research 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 marketing - 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 web-based clinical data capture and analysis tool or "system" to help them truly understand statistical trends and patient outcomes.

ClinicalPURSUIT Patient Registry Software 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 Clinical Trials:

 

  • HIPAA compliant/patient privacy
  • Multi-center collaborative research
  • 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