Since 1999, The Camden Group has provided clinical development consulting and implementation services to the pharmaceutical industry in a wide variety of therapeutic areas. We are familiar with the U.S. and global regulatory environments and applicable guidances and requirements, have extensive FDA experience, and have worked with clients to successfully launch products globally.
Rheumatology
Metabolic Disease
Pain
Dermatology
Cardiovascular
Neurology
Oncology
Urology
Infectious Disease
Osteoporosis
The Camden Group has worked with Sponsors to develop small molecules (NCEs), biologics, and biosimilars for oral, intravenous, intramuscular, subcutaneous, topical, and epidural administration.
Assessment of market potential
Assessment of development potential
Evaluation of in-licensing opportunities and new product candidates
Phase I-IV clinical program development and trial design
Clinical Project Management
Clinical Monitoring
Medical Monitoring
Generation of full study and clinical program budgets
Preparation of clinical protocol synopses for internal Sponsor discussion and funding exploration
Preparation of full clinical study protocols Phase I through Phase IV
Preparation of study- and site-specific documents
Preparation of Pre-IND, IND, NDA (including ISS and ISE), and other regulatory submissions
Definition of regulatory strategy for both traditional and novel indications and claims
Clinical Study Implementation Phase I through Phase IV
Since 1999, The Camden Group has provided clinical development consulting and implementation services to the pharmaceutical industry in a wide variety of therapeutic areas. We are familiar with the U.S. and global regulatory environments and applicable guidances and requirements, have extensive FDA experience, and have worked with clients to successfully launch products globally. 
