Clinical Development & Medical Affairs

Are Your CROs Well Managed?

NovusLife clinical development and medical affairs services are focused on providing careful management of your CROs in order to efficiently advance product candidates through clinical development. Our clinical professionals have a depth and breadth of clinical experience and therapeutic expertise to get you what you need, when you need it. We see the big picture, while maintaining focus on the day-to-day details of trial and CRO oversight. We drive your Phase 1-4 clinical studies to a successful conclusion, through services such as these:

Program/Project Management
Endpoint development and validation
Optimal protocol design, writing and management
KOL engagement
Site selection, start-up and management
Contract management and investigator reimbursement
Global study site management
Oversight of clinical trial execution
Data review/auditing
Biostatistics and Medical Writing
Clinical Evidence to optimize disease messaging and approvals
Special expertise in Orphan indications
Design & management of Registry and REMS studies
Regulatory strategy to achieve product label goals
Creation of regulatory documents (Pre-IND/EOP2/NDA/BLA/IDE/510k)

Our goal is to help you advance your product candidates or devices to the next value inflection point, or all the way to the market and the patients in need. Toward that end, NovusLife consultants will lead your clinical development project from concept through to final study reports – or to specific points in between to meet your business needs. Working together with you, we will quickly identify your study’s critical path, milestones, and go/no-go decision points. Most important of all, we serve as seamless members of your team, helping you to get the most out of your chosen CRO, be they local or global.

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