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Top issues facing ClinOps executives

Never before have operating conditions for clinical studies been more difficult. Clinical operations groups face growing pressure to get drugs to market faster while improving efficiencies and study quality. Development costs continue to rise. At the same time, the logistics of conducting a clinical trial have become more complex in the increasingly competitive and regulated environment.

Renewed attention for investigator-initiated trials

After a five- to eight-year decline, investigator-initiated trials (IITs) are gaining renewed interest as more biopharmaceutical companies are using them as a creative and cost-effective way to innovate and further improve patient safety.

Also in this issue:

• The changing landscape of clinical trials in Asia and the Pacific Rim
• The research site: Contract negotiation underdog
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline