The Camden Group provides clinical development services to fit a broad range of clinical needs. Our experience working with multiple divisions of the FDA through all phases of drug development assures our clients of regulatory insight and compliance. We work flexibly with each client, and are equally comfortable and experienced working as an extension of the client’s project team, or independently to provide deliverables tailored to the individual needs of our clients. We pride ourselves in our commitment to excellence and to exacting professional standards.
The Camden Group’s clinical development services include:
Design of Clinical Development Programs
Preparation of Clinical Development Plans for targeted indications
Design of Phase I – IV studies
Generation of full study and clinical program budgets
Preparation of clinical protocol synopses for internal client discussion
Preparation of clinical protocol synopses for vendor selection and funding exploration
Preparation of full clinical study protocols Phase I through Phase IV
Preparation of Pre-IND, IND, NDA (including ISS and ISE), and other regulatory submissions