Learn the five requirements for designing effective, local, observational research that can support global product strategies.
Late-Stage Clinical Operations
More Tools to Simplify Your Journey Before and After Approval
When it’s time to shift your development journey toward commercialization to gain first market access, PAREXEL® Access can help you do it seamlessly, securely, and cost-effectively. For over a decade, our global late phase specialists have customized scientific, strategic, and market-savvy solutions that help our clients overcome every obstacle to reach their destination: Getting important medications to the people who need them most.
PAREXEL has the global infrastructure, multi-disciplinary expertise, and integrated technologies to help you implement a market strategy that will quickly build your brand value and establish a strong market position – all while continuing to monitor your new drug’s long-term effects and manage related safety data and other regulatory information. At a time when exclusivity and patent protections are decreasing and regulatory demands are increasing, having a late phase specialist with world-class experience and resources to guide you through could extend your marketplace presence substantially.
Our Late Phase expertise also simplifies your journey using:
• Dedicated Project Management Staff with global and local late phase experience.
• Global Presence with Local Market Penetration to customize solutions to the target market.
• Focused Site Management with worldwide remote monitoring capacity to manage costs.
• Integrated SaaS-based Technologies that optimize data flow, trial management, and reporting.
Learn the best way to move your product from development to the marketplace to insure your best chances for commercial success.
Learn how real-world data from a broad spectrum of patients and physician-prescribing patterns can deliver new insights.
Learn more about a road map to success for phase IV, observational, and registry studies in the Middle East.
Late Phase Interventional Trials
PAREXEL® Access supports clients with strategies and systems specifically developed for late phase interventional trials. Our experience spans many therapeutic areas and ranges from single-country studies to those carried across multiple national boundaries and continents.
Monitoring the safety of medicinal products is a key concern throughout the product's lifecycle. At the time of product launch, drugs will have been tested on, at most, only a few thousand patients. This very fact is a concern to the EMEA, the FDA, and other regulatory agencies...
Observational / Non-interventional Research
Observational research encompasses several study designs in which groups of patients are observed within routine clinical practices. In the biopharmaceutical and medical device industries, observational studies can provide valuable insights into the causal association between…
PAREXEL® understands that requirements regarding post-marketing safety monitoring are more stringent now than ever. Numerous incidents involving marketed pharmaceuticals and over-the-counter (OTC) medicines in recent years have brought the issues of safety monitoring…