Clinical Strategy and Operations

Clients often have access to or relationships with clinical Key Opinion Leaders (KOLs) in therapeutic areas relevant to their development programs.  However, KOLs who may be leaders in clinical research often can use our M.D. clinical experts who are knowledgeable about regulatory expectations in clinical trial design and execution.  Our experts provide, among other things: 

• Clinical development plans, budgets and timelines 
• Protocol design and supporting documentation 
• Clinical Regulatory Statistics 
• Preparation of IB, Informed Consent and similar documents 
• Pediatric Investigation Plan 
• CRO selection and management 
• Medical monitoring 
• Clinical operations