Therapeutic Areas St. Louis | Biotechnology Companies

About Us
Our Services
Experience

Smart Advice. Exacting standards.
Meticulous Execution.

Exceptional Results.

The Camden Group, LLC brings over 40 years of combined experience and a track record of excellence in clinical research in a wide variety of therapeutic areas. We bring FDA knowledge and experience from pre-IND through Phase IV.

The Camden Group, LLC works with R&D teams in large pharmaceutical and small biotechnology companies. Our working relationships with each of our clients are directed by the demands of the project and the preferences of the client. We have worked with clients both on-site and remotely, tailoring our work style and degree of involvement with the client’s in-house staff to the project and program needs. We work with clients for whom the requested deliverable is modest and requires hours or days, and those for whom we are able to provide guidance over several years.

Our Work

Since 1999, The Camden Group, LLC has provided clinical development consulting and implementation services to the pharmaceutical industry in a wide variety of therapeutic areas. We are familiar with the US and global regulatory environments and applicable guidances and requirements, have extensive FDA experience, and have worked with clients to successfully launch products globally.

Therapeutic Areas of Expertise

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Rheumatology
Metabolic Disease
Pain
Dermatology
Endocrinology
Fibromyalgia

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Cardiovascular
Neurology
Oncology
Women's Health
Allergy
Sleep

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Urology
Infectious Disease
Osteoporosis
Virology
Inflammation
Alcoholism

The Camden Group, LLC has worked with Sponsors to develop small molecules (NCEs), biologics, biosimilars, and nutritional/dietary supplements for oral, intravenous, intramuscular, subcutaneous, topical, and epidural administration.

Development Guidance and Assistance From Bench to Bedside

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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

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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/BLA (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

Our Clients

Past Clients Include:

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8 Fortune 500 Pharmaceutical Companies
5 of the Top 20 International Pharmaceutical Companies

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Over 30 Biotechnology Companies

Venture Capital Firms

What Clients Are Saying About the Camden Group, LLC

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“Provided invaluable assistance in successfully planning, executing, and reporting a variety of clinical studies”

“Demonstrated solid judgment"

"Excellent ability to simplify complex problems and present realistic practical solutions”

"Responsive to our needs and accommodated to short notice and sudden changes in development programs”

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“Their breadth of experience allows for an integrated approach to drug development”

“Unique combination of a sound scientific base coupled with a ‘real world’ business sense”

“Clear thinkers with great anticipatory skills”

“Proficient organizers who rapidly isolate, focus, and frame the issues”

“Problem solvers who make clear practical recommendations”