The FDA has released a flurry of guidance that signals its growing willingness to accept flexible study designs and real-world evidence in drug submissions for rare disease trials — welcome news for study sponsors because it opens the door for new technology and new models to recruit and retain rare disease patients.

More Sites Seek ‘Partner of Choice’ Label

Investigative sites have stepped up efforts to become more attractive as “partners of choice” in clinical research, eager to move toward the top of highly competitive preferred provider lists, as they increasingly recognize the importance of meeting sponsor and CRO needs for greater efficiency and collaboration in order to win more business.

• Five Steps To Enhance The Clinical Trial Patient Experience
• Why patient engagement is critical to clinical trials
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline