Health Decisions: The CRO of choice for forward-looking biopharma & device companies

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Prepare for the challenges of 2015 by downloading Top 10 Clinical Development Trends for 2015: Regulatory, Operational, Design and Commercial Considerations for Successful Trials and Programs.

Clinical development executives will face intense and widespread change in 2015. The shift from development of drugs for large populations to greater focus on targeted therapeutics will accelerate. FDA emphasis on including important subgroups in trials and on patient-focused development may raise new issues in recruitment and communication. In Europe, the new Clinical Trials Regulation will evolve toward its final form, complicating planning. Orphan Drugs will be central to plans of many companies and yet inherently small target markets and persistent reimbursement issues will demand careful analysis and timely decisions. The boom in oncology development will continue, with growing emphasis on immunotherapies. We will see increased utilization of risk-based monitoring, Electronic Health Records, Bayesian statistics and adaptive designs, a quest for greater clarity in endpoints in CNS trials, and new challenges in infectious disease in the wake of the Ebola outbreak in West Africa.

This white paper will help clinical development experts prepare for the challenges associated with such trends as:

  • Patient-focused drug development
  • Growth in Orphan Drug development and targeted therapeutics
  • Collection and analysis of data on demographic subgroups
  • Adoption of risk-based monitoring
  • Increasing utilization of Bayesian statistics and adaptive design
  • The growing importance of Electronic Health Records

Individualized Information and Strategic Advice

For expert advice on program planning and trial design as well as precise project governance and high-quality, high-speed trial execution, please contact the clinical development experts at Health Decisions. For a personalized discussion of your development priorities and challenges, click below to schedule a time to talk with a Health Decisions expert.

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