7 Ways to Reduce Inflammation Study Challenges

4 Jun 2014

The following whitepaper offers seven approaches recommended by Covance to reduce common inflammation clinical study challenges. These proactive approaches are based on our experience carrying out clinical trials in this area, as well as an acknowledgement that the re-applicability of therapies to different Immune-Mediated Inflammatory Disorders (IMIDs) also enables operational improvements to the conduct of IMID clinical trials.

Covance Clinical Development (Phase I-III) Service

Covance Laboratories Inc.

Your product development plans deserve the best integrated program of research services available - so choose Covance. With pressure to substantially increase numbers of trial participants, increased scrutiny on product safety and stringent regulatory controls throughout the world, Covance is ready to partner and bring to the fore the expertise, resources and insight required to guide you through the complex and challenging course of biopharmaceutical development.Our integrated clinical development services are unique to Covance. Acquire the global reach and therapeutic record of success from one of the few truly global drug development companies positioned to provide comprehensive clinical support from First-in-Human studies through pivotal Phase III global clinical trials.

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Covance Clinical Development (Phase II-IV) Service

Covance Laboratories Inc.

Total flexibility. Covance's Clinical Development services are customized to your specific needs. The stakes are high as your drug enters clinical development in Phase II-III. With your drug’s future on the line, you need to navigate a global maze of patient populations, practice patterns and regulatory requirements, often also languages and time zones, before the goal of regulatory approval is in sight. It’s challenging and requires a broad range of expert resources.That’s why Clinical Development Phase II-III is there to help you manage the complex clinical development experience simply, efficiently, comprehensively and successfully.Service Features: Comprehensive planning through Covance’s P3 (predictive, proactive, preventative) Operating Platform - builds quality into your trials before they begin, helping to prevent errors, proactively minimize delays and mitigate risks, and optimize performance. Access to Covance’s end-to-end suite of services - offers all the resources you need for global clinical trials in Phase II-III High quality data, on time and without surprises - based on our ability to coordinate and align numerous global data streams Clinical trial support in more than 55 countries - an unparalleled reach through our worldwide network of scientific and operational professionals, who are experts in local regulatory, health, and research issues A simplified approach to contracting and vendor management - that frees you from the burden of coordinating subcontractors, making internal decisions, and supervising operational hand-offs, letting you spend more time on core tasks. You access these and other benefits through your project manager, a seasoned professional with relevant scientific and therapeutic expertise who serves as your central contact throughout the entire process. And whose sole mission is your success.

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Covance Regulatory Services

Covance Laboratories Inc.

Superior Regulatory Service Helps Transform Your Clinical Trials. Strong regulatory strategies are pivotal in getting products to market. While many countries’ drug regulations are similar, there are still significant differences. These similarities and differences are the basis of a global regulatory strategy that encompasses the needs of all regions. Serving you where you need to be, our Regulatory Affairs teams are located throughout North America, Latin America, Asia Pacific and Europe.As global regulatory requirements continue to evolve, Covance’s expertise helps you increase your chance of regulatory approval. With over 150 regulatory affairs professionals in more than 14 countries around the world, we help you navigate regulatory requirements throughout your product’s development lifecycle.Services include: Course corrections throughout development when necessary Orchestrating Agency interactions Managing regulatory submissions, including the filing of global Marketing Applications

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7 Ways to Reduce Inflammation Study Challenges